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Notice to buy kamagra oral jelly wholesale Reader. This guidance clarifies the new amended Medical Device Regulations that deal with incident reporting, in effect as of June 23, 2021. See the guidance clarifying the Medical Devices Regulations that are currently in effect buy kamagra oral jelly wholesale. Download in PDF format(819 KB, 21 pages) Effective Date. New provisions under sections 59 to 61.1 effective June 23, 2021Supersedes.

October 3, 2011 Foreward Guidance documents are meant to provide assistance on how to comply with governing statutes and regulations buy kamagra oral jelly wholesale. They also serve to provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent and effective. Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided buy kamagra oral jelly wholesale they are supported by adequate justification. Alternate approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, in order to allow the Department to adequately assess the safety, efficacy or quality of marketed health products. Health Canada is committed to ensuring that such requests are justifiable buy kamagra oral jelly wholesale and that decisions are clearly documented. This document should be read in conjunction with relevant sections of other applicable guidance documents. On this page 1 Introduction 1.1 Purpose The purpose of this guidance document is to assist manufacturers, importers and authorization holders in understanding and complying with the Medical Devices Regulations concerning incident reporting (sections 59 through 61.1(2)). 1.2 Background The incident reporting provisions in the Regulations are intended to improve monitoring and reduce the recurrence of incidents related to medical devices in Canada, and to ensure that the risk to Canadians of problematic devices is managed buy kamagra oral jelly wholesale appropriately.

Since Health Canada and its regulatory partners have similar reporting requirements, the Regulations enable Health Canada's participation in international alert systems. Health Canada, along with its international partners in the Global Harmonization Task Force (GHTF), has developed agreements and documents to promote a harmonized approach to medical device regulation around the world. One of the study groups within the GHTF buy kamagra oral jelly wholesale has produced a document entitled " Medical Devices Post Market Surveillance. Global Guidance for Adverse Event Reporting for Medical Devices" (N54) which sets out criteria for adverse event reporting. In discussing the incident reporting requirements of the Regulations, this document is also intended to illustrate Health Canada's support of the general principles of harmonization and the goals of the GHTF.

1.3 Scope This guidance document is intended as a supplement to the Regulations, to aid in the interpretation of the buy kamagra oral jelly wholesale incident reporting requirements. 1.4 Definitions The following definitions are set out for the purposes of interpretation of this document. Abnormal use An act, or omission of an act, by the user of a medical device as a result of conduct that is beyond any reasonable means of risk control by the manufacturer. Foreseeable misuse that is warned against in the instructions for use is considered abnormal use if buy kamagra oral jelly wholesale all other reasonable means of risk control have been exhausted. See Appendix A for examples of potential abnormal uses.

Note. Abnormal use includes intentional use for a non-approved purpose. Authorization holder Holder of a therapeutic product authorization, as defined in section 2 of the Food and Drugs Act. Complainant The person who made the initial report of the incident to a representative of the manufacturer or the importer. The complainant may be the patient, the user of the device or other person.

Correction Action to eliminate a detected nonconformity including the repair, modification, adjustment, relabelling, or inspection (including patient monitoring) of a device without its physical removal to some other location. A correction can be made in conjunction with a corrective action. A correction can be, for example, rework or regrade (International Standards Organization, ISO 13485 Medical Devices quality management systems - System requirements for regulatory purposes). A correction can also be a recall to address nonconforming devices in distribution. Note.

A nonconformity may include a problem or malfunction with the device Corrective Action Action to eliminate the cause of a detected nonconformity or other undesirable situation. There can be more than one cause for a nonconformity. Corrective action is taken to prevent recurrence, whereas preventive action is taken to prevent occurrence. There is a distinction between correction and corrective action (ISO 13485 Medical Devices quality management systems - System requirements for regulatory purposes). Note.

A nonconformity may include a problem or malfunction with the device. If the corrective action meets the definition of a recall, according to the Regulations, then recall reporting requirements would apply Importer A person, other than the manufacturer of a device, who causes the medical device to be brought into Canada for sale. Incident In the context of incident reporting, information on the incident refers to the circumstances required to be reported under section 59 of the Medical Device Regulations. Malfunction or deterioration A failure of a device to perform in accordance with its intended purpose when used in accordance with the manufacturer's instructions. Malfunction is synonymous with "fault".

Manufacturer As is defined in section 1 of the Regulations, this term means a person who sells a medical device under their own name, or under a trade mark, design, trade name or other name or mark owned or controlled by the person, and who is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the device, or for assigning it to a purpose, whether those tasks are performed by that person or on their behalf. Preventive action Action to eliminate the cause of a potential nonconformity or other undesirable potential situation. There can be more than one cause for a potential nonconformity. Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence. Note.

A nonconformity may include a problem or malfunction with the device Radiation emitting device As per the Radiation Emitting Devices Act, it refers to:(a) any device that is capable of producing and emitting radiation, and(b) any component of or accessory to a device described in paragraph (a);where radiation means energy in the form of electromagnetic waves or acoustical waves. Recall As is defined in section 1 of the Regulations, in respect of a medical device that has been sold, recall means any action taken by the manufacturer, importer or distributor of the device to recall or correct the device, or to notify its owners and users of its defectiveness or potential defectiveness, after becoming aware that the device ( a) may be hazardous to health. ( b) may fail to conform to any claim made by the manufacturer or importer relating to its effectiveness, benefits, performance characteristics or safety. Or ( c) may not meet the requirements of the Act or the Regulations. Reporter The person required to report incident reports to Health Canada, in accordance with the Regulations.

Serious deterioration in the state of health As is defined in section 1 of the Regulations, this term means a life-threatening disease, disorder or abnormal physical state, the permanent impairment of a body function or permanent damage to a body structure, or a condition that necessitates an unexpected medical or surgical intervention to prevent such a disease, disorder or abnormal physical state or permanent impairment or damage. Note. Serious deterioration in health also includes a serious public health threat which is any incident type, which results in imminent risk of death, serious deterioration in health, or serious illness that requires prompt remedial action. Serious risk of injury to human health Where it is likely that a serious deterioration in the state of health will occur and elicits risk mitigating actions or measures to prevent it. Use error Act, or omission of an act, that has a different result to that intended by the manufacturer or expected by the user.

Use error includes slips, lapses, mistakes and reasonably foreseeable misuse. See Appendix A for examples of potential use errors. User Person responsible for the use of the device. This could be, for example, a health professional, a family member, or even the patient (in the case of a glucose meter, for example). 2 Interpretation 2.1 Interpretation For the purpose of this document, the manufacturer, importer (subject to section 61.1 of the Regulations) and authorization holder (subject to Section 61.2), are considered to be reporters of the incident to Health Canada.

The complainant is the patient, user, or other person who initially brought the incident to the attention of the reporter. 2.2 What is an incident report?. An incident report is required under section 59 of the Regulations for any incident involving a medical device that is sold in Canada when the incident. Occurs within Canada (section 59(1));occurs outside Canada for a Class I medical device (section 59(1.1));relates to a failure of the device or a deterioration in its effectiveness, or any inadequacy in its labelling or in its directions for use (section 59(1)(b)(i)). Andhas led to the death or a serious deterioration in the state of health of a patient, user or other person, or could do so if it were to recur (section 59(1)(b)(ii)).Note.

This guidance document interprets "sold" to mean "authorized for sale" (for Class II, III, IV medical devices), regardless of whether any units have yet been distributed. The manufacturer and importer are each required to make both a preliminary and a final mandatory report, unless the manufacturer provides the Minister written authorization to permit the importer to report on its behalf (see section 61.1(1)-61.1(2) of the Regulations). Manufacturers remain responsible for ensuring that the information in the incident report is both complete and accurate. An incident report is required under section 59(1.1) of the Regulations for any incident, involving a Class I medical device, occurring outside Canada (foreign incidents). Under this provision, incident reports for foreign incidents are no longer required for Class II-IV devices.

Class II-IV devices must adhere to section 61.2 a notification provision of a foreign action, where there is a serious risk of injury to human health. Guidance on this provision can be found here. Note. A manufacturer or importer of a radiation emitting device who sends a report to MHPD for the Mandatory Medical Device Problem Reporting Program which concerns a matter within the scope of section 6 of the Radiation Emitting Device Act does not have to be re-submit it to the Consumer and Clinical Radiation Protection Bureau (CCRPB) in order to fulfil the notification requirements set out in that section. 2.3 How do I decide if the incident is reportable to Health Canada?.

2.3.1 All Incidents In accordance with section 59 of the Regulations, any incident which meets all of the three basic reporting criteria described in section 2.4 below, is considered a reportable incident and must be reported to Health Canada. Note. When a manufacturer, or importer, receives a complaint about a device which meets the three basic criteria described in section 2.4, it must be reported even if the device no longer holds a market authorization in Canada. It is possible that the reporter will not have enough information to decide on the reportability of an incident. In such a case, the reporter should make reasonable efforts to obtain additional information to aid in the decision.

Where applicable, the reporter should consult with the medical practitioner or the health professional involved, and make all reasonable efforts to retrieve the device for evaluation. 2.3.2 Foreign Incidents Foreign incidents, for Class I devices only, must be reported in accordance with section 59(2) of the Regulations. Foreign incidents, involving Class I device(s), which occurred prior to the specific incident which resulted in the decision to report a corrective action to a foreign regulatory authority (or to the request by the foreign regulatory authority for a corrective action to be undertaken) need not be reported to Health Canada. These incidents should, however, be considered in the rationale for undertaking any future corrective action(s). The specific foreign incident which resulted in the decision to undertake a corrective action should be reported to Health Canada.

Foreign incidents occurring after the decision to undertake a corrective action, and having the same root cause as the incident which precipitated that decision, need not be reported to Health Canada, unless they result in another, separate corrective action. Note. Guidance on the timing of reporting foreign incidents to Health Canada is found in section 2.9 below. 2.4 What are the criteria to determine reportability?. 2.4.1 An incident has occurred - Section 59(1) The reporter becomes aware of information regarding an incident which has occurred with its device.

This may include information from device testing performed by the manufacturer, user or other party. 2.4.2 The device contributed to the incident - Section 59(1)(b)(i) In assessing the link between the device and the incident, the reporter should take into account. the opinion, based on available information, from a health professional. Information concerning previous, similar incidents. Complaint trends.

And any other information held by the reporter. This judgment may be difficult when there are multiple devices and drugs involved. If, after becoming aware of a potentially reportable incident, there is uncertainty about whether it is reportable, the reporter should submit a report within the timeframe required for that type of incident. 2.4.3 The incident lead to one of the following outcomes - Section 59(1)(b) 2.4.3.1 Death of a patient, user or other person When the first two criteria to determine whether an incident is reportable (sections 2.4.1 and 2.4.2 above) are met, and when death is the result of an incident, a report to Health Canada must be submitted within 10 calendar days, in accordance with section 60(1)(a)(i) of the Regulations. 2.4.3.2 Serious deterioration in the state of health of a patient, user or other person When the first two criteria to determine whether an incident is reportable (sections 2.4.1 and 2.4.2 above) are met, and when serious deterioration in the state of health is the result of an incident, a report to Health Canada must be submitted within 10 calendar days, in accordance with section 60(1)(a)(i) of the Regulations.

Under the Regulations, a serious deterioration in health means a life-threatening disease, disorder or abnormal physical state, the permanent impairment of a body function or permanent damage to a body structure, or a condition that necessitates an unexpected medical or surgical intervention to prevent such a disease, disorder or abnormal physical state or permanent impairment or damage. The interpretation of the term "serious" should be made in consultation with a medical professional, when appropriate. The term "permanent" means irreversible impairment or damage to a body structure or function, and necessarily excludes minor impairment or damage. Medical intervention is not in itself a serious deterioration in health. The reason that motivated the medical intervention should be used to assess the reportability of an incident.

2.4.3.3 Potential for death or serious deterioration in health of a patient, user or other person Not all incidents lead to a death or to a serious deterioration in health, either owing to circumstances or to the timely intervention of health care personnel, for example. These situations are known as near incidents. If the incident, in the case of recurrence, could lead to a death or to a serious deterioration in health, a report to Health Canada must be submitted within 30 calendar days, in accordance with section 60(1)(a)(ii) of the Regulations. This requirement also applies if the examination of the device, or a deficiency noted in the information supplied with the device, or any information associated with the device, indicates some factor which could lead to an incident involving death or serious deterioration in health. In the report to Health Canada, it is recommended that all relevant information that might impact the understanding or evaluation of the incident be included.

For example, "the patient was confused prior to becoming trapped in the bedsides". "the patient was a very low birth weight premature delivery and had a central line placed three days before onset of cardiac tamponade". "the X-ray machine was over 20 years old and had been poorly maintained at the time of the incident ", etc. This information should also include an explanation of how this incident could have led to a death or to a serious deterioration in health. 2.5 Examples of reportable incidents Loss of sensing after a pacemaker has reached "end of life".

Elective replacement indicator did not show up in due time, although it should have according to device specification. During patient examination, the "C" arm on an X-ray vascular system had uncontrolled motion. The patient was hit by the image intensifier. The system was installed, maintained, and used according to manufacturer's instructions. It was reported that a monitor suspension system fell from the ceiling when the bolts holding the swivel joint broke off.

No one was injured in the surgical theatre at that time but a report is necessary (near incident). The system was installed, maintained, and used according to manufacturer's instructions. Sterile, single-use device packaging was labelled with the caution, "Do not use if package is opened or damaged". By incorrect design, the label is placed on the inner packaging. Device was subsequently stored only in the inner packaging, which did not offer a sufficient sterile barrier.

Outer package was removed, but device was not used during procedure. A batch of out-of-specification blood glucose test strips is released by manufacturer. Patient uses strips according to instructions, but readings provide incorrect values leading to incorrect insulin dosage, resulting in hypoglycemic shock and hospitalization. Premature revision of an orthopaedic implant due to loosening. No cause yet determined.

An infusion pump stopped, due to a malfunction, but failed to give an alarm. Patient received under-infusion of needed fluids and required extra days in hospital to correct. Patients undergoing endometrial ablation of the uterus suffered burns to adjacent organs. Burns of adjacent organs due to thin uterine walls were an unanticipated side effect of ablation. Manufacturer does not change the label of the ablation device, and fails to warn users of this side effect which may be produced when the device is working within specification.

Health professional reported that during implant of a heart valve, the sewing cuff is discovered to be defective. The valve was abandoned and a new valve was implanted and pumping time during surgery was extended. During the use of an external defibrillator on a patient, the defibrillator failed to deliver the programmed level of energy due to malfunction. Patient was not revived. Note.

If patient was revived, this would be considered a near incident and would also be reportable. Testing of retained samples identified inadequate manufacturing process, which led to detachment of tip electrode of a pacemaker lead, which did, or could, result in the death or serious deterioration in health of an individual. A user reported that there were insufficient details in the instructions for use regarding cleaning methods for reusable surgical instruments used in brain surgery, despite obvious risk of transmission of variant Creuzfeld-Jacob Disease (vCJD). 2.6 Multiple incidents with the same device Reportable incidents involving a medical device that affected one or more patients, users or other persons, on the same, or different, dates are to be reported to Health Canada as separate incidents, because each incident was a separate event. However, in the case of a medical device, such as an automated chemistry analyzer, a reportable incident concerning a particular run or rack of analyses (containing samples from one or more patients) should be reported to Health Canada as a single incident, because the entire rack of analyses represent a single event.

2.7 Use error As with all reported device complaints, all potential use error incidents must be evaluated by the reporter (see Appendix A for examples). The evaluation should include principles of risk management, usability engineering, design validation, and corrective and preventive action processes. Importers may need to coordinate their evaluation with the manufacturer, in order to ensure that these elements are addressed. Results should be available, upon request, to Health Canada. Please refer to section 2.8.4, below, for guidance on abnormal use ("off-label" use).

2.7.1 Reporting of use error There is increased international focus on errors in the use of medical devices. Incidents associated with use error must be evaluated by the reporter and the results documented. These types of incidents can be controlled by the manufacturer's quality systems corrective and preventive action requirements, design validation, usability engineering, and risk management processes. By their nature, incidents involving use error usually involves a degree of uncertainty as to the root cause, but the risks can be managed by the manufacturer through consultation with Health Canada. 2.7.2 Use error resulting in death or serious deterioration in health Use errors related to medical devices, which did result in death or serious deterioration in health, must be reported to Health Canada, providing the criteria specified in 2.4 above were also met.

2.7.3 Use error not resulting in death or serious deterioration in health Use errors related to medical devices, which did not result in death or serious deterioration in health, but which have the potential to result in death or serious deterioration in health, also need to be reported to Health Canada, providing the criteria specified in section 2.4 above were also met. 2.8 What types of common incidents or situations do not meet the reporting criteria?. 2.8.1 Deficiency of a device found by the user prior to patient use Deficiencies of devices that would always be detected by the user, and where death or serious deterioration in health has not occurred, do not need to be reported, because they do not meet requirements of section 59(1)(b) of the Regulations. In these situations, "always" means that even if the incidents were to recur, the user would, again, always detect the defect or malfunction prior to use. Examples of non-reportable incidents.

User performed an inflation test prior to inserting the balloon catheter in the patient as required in the instructions for use accompanying the device. A malfunction on inflation was detected. Another balloon was used. Packaging of a sterile, single-use device was labelled with the caution, "Do not use if package is opened or damaged", but damage to the packaging was obvious, was discovered, and occurred after manufacture. The device was not used.

2.8.2 Incident caused by a patient's condition When the reporter has information that the root cause of the incident is definitely due solely to a patient's condition, the incident does not need to be reported, because it does not meet the requirements of section 59(1)(b)(i) of the Regulations. These conditions could be pre-existing or occurring during device use. To justify not submitting a report, the reporter should have documented information available to conclude that the device performed as intended and did not cause, or contribute to, death or serious deterioration in health. A person qualified to make a medical judgment would accept the same conclusion. Examples of non-reportable incidents.

Revision of an orthopaedic implant owing to loosening caused by the patient developing osteoporosis. A patient died after dialysis treatment. The patient had end-stage-renal disease and died of renal failure. The death of a patient that was unrelated to any implanted device or device used to treat the patient. 2.8.3 Malfunction protection operated correctly Incidents which did not lead to a death or to a serious deterioration in health because a design feature protected against a malfunction becoming a hazard, do not need to be reported, because they do not meet the requirements of section 59(1)(b)(i) of the Regulations.

Examples of non-reportable incidents. After a malfunction of an infusion pump that was not related to a manufacturing defect, the pump gives an appropriate alarm and stops. There was no harm to the patient.Microprocessor-controlled radiant warmer malfunctions, reverts to an appropriate default condition and provides an audible, appropriate alarm. There was no harm to the patient.During radiation treatment, the automatic exposure control is engaged. Treatment stops.

In accordance with the relevant standards, the actual dose is displayed. Although patient receives less than optimal dose, patient is not exposed to excess radiation.During radiation treatment, the automatic exposure control is engaged. Treatment stops. In accordance with the relevant standards, the actual dose is displayed. Although patient receives less than optimal dose, patient is not exposed to excess radiation.

2.8.4 Consideration for handling abnormal use Abnormal use includes intentional use for a non-approved purpose ("off-label" use). It should not be confused with use error (see section 2.7). As with all reported device complaints, all potential abnormal use incidents must be evaluated by the reporter (see Appendix A for examples). Abnormal use need not be reported to Health Canada under mandatory reporting regulations. Abnormal use should be managed by the health care facility and the appropriate provincial or territorial departments of health under specific and appropriate schemes not covered by this document.

2.9 What time frames are specified for reporting an incident to Health Canada?. All reporting time frames refer to when Health Canada must first be notified. This notification may be in the form of a preliminary report, or a combination of a preliminary and final report. The choice of report type depends on whether all the required information is available within the appropriate report timeframe. The Mandatory Medical Device Problem Reporting Form for Industry can be used to report preliminary, updates, final, or preliminary and final reports to Canada Vigilance - Medical Device Problem Reporting Program.

Note. The date that a representative of the reporter is notified of the issue ("awareness date") is considered by Health Canada to be day zero. 2.9.1 Preliminary report for an incident occurring in Canada Section 60(1)(a) of the Regulations requires that if the death or serious deterioration in health of the patient, user or other person has occurred, a report must be submitted to Health Canada within 10 calendar days. If death or serious deterioration in health did not occur as a result of the incident, but might if the incident were to recur, then the report must be submitted to Health Canada within 30 calendar days. If, after becoming aware of a potentially reportable incident, there is uncertainty about whether it is reportable, the reporter should submit a report within the timeframe required for that type of incident.

2.9.2 Preliminary report for an incident occurring outside Canada When the decision has been made to report a foreign incident to Health Canada (see section 2.3.2 above, for the criteria), section 60(1)(b) of the Regulations requires that a preliminary report be submitted as soon as possible after the manufacturer has informed the foreign regulatory agency of the intention to take corrective action, or, as soon as possible after the foreign regulatory agency has required the manufacturer to take corrective action. Note. In this case, Health Canada interprets "as soon as possible" to mean within 48 hours after the decision. A combined preliminary and final report may be submitted to Health Canada if the incident investigation is complete. 2.9.3 Requirement regarding a timetable for submission of the final report for an incident Section 60(2)(h) of the Regulations requires, as part of the preliminary report, that the reporter propose a timetable for carrying out any corrective actions and for submitting the final report.

Health Canada will review the proposed timetable to ensure that it does not jeopardize the safety of patients and users. The reporter should provide a final report as soon as the information is available, or as requested by Health Canada. The timetable should include proposed dates relating to the action plan for resolving the issue, and should not merely include the proposed date for submission of the final report. If the investigation is still in a very preliminary state (e.g.. For a 10-day report), it may be that the timetable only indicates the immediate actions taken (or to be taken) and the proposed date(s) for any updates and for the final report.

Note. A report that contains the information required for a combined preliminary and final report may be submitted to Health Canada, provided that the results of the investigation are available within the 10-calendar-day or 30-calendar-day timeframe for submitting a preliminary report. 2.10 What content is required for an incident report?. 2.10.1 Preliminary report The purpose of a preliminary report is to inform Health Canada that, 1) a reportable incident has taken place, and 2) the reporter has begun the investigative process required to determine the root cause. 2.10.1.1 What information must be submitted in the preliminary report?.

Section 60(2) of the Regulations sets out the information requirements for a preliminary report. The required information is listed below by section number, with a brief explanation where necessary. References made to the reporter mean the reporter of the incident to Health Canada, and not the complainant. Section 60(2)(a) requires the reporter to submit information which will allow for ready identification of the device involved in the incident. This shall include the name of the device (for example.

The trade name), the medical device identifier, the device catalogue number, device license number, the model number, serial number, lot number, etc. Sections 60(2)(b)(i) and (ii) require the reporter to specify the manufacturer and the importer (as appropriate) of the device involved in the incident. Information required includes the name and address of the manufacturer and of the importer of the device (as appropriate). Additional information includes the name, title, telephone and facsimile numbers of the reporter, in order to facilitate contact for any additional information concerning the incident that may be requested by Health Canada. Section 60(2)(c) requires the submission of the incident awareness date, which is the date the incident came to the attention of the reporter.

Section 60(2)(d) requires the submission of the details known in respect of the incident, including the date the incident occurred and the consequences for the patient, user or other person. The details may include but are not limited to the following. What happened (where, when, how, to whom)?. Is this the first time the device was used by the hospital?. the health care worker?.

the patient?. the user?. If not, how long has the device been in use?. When was it used previously?. Have there been any previous problems with the device?.

If so, how often have these problems occurred?. Was the device used according to directions?. What were the environmental conditions surrounding the incident (if applicable)?. What were the parameters or control settings at the time of the incident?. How many other units of the device were involved in the incident?.

Was the device misused in any way (for example. Reuse of a single-use device)?. What method was used to clean, sterilize or re-sterilize the device?. Was this consistent with the manufacturer's recommendations?. How was the product stored or maintained?.

Consequences referenced in section 60(2)(d) are the details of any harmful health effect(s) from the incident, the severity of the effect(s) and any treatment required. Section 60(2)(e) requires the reporter to submit the name, address and telephone number, etc, if known, of the person who reported the incident to the manufacturer or importer. Section 60(2)(f) requires the reporter to submit the identity of any other medical devices or accessories involved in the incident, if known. This refers to any other equipment that was used with the device or in the vicinity of the device. It is also useful to include information concerning drugs used concomitantly with the device.

Section 60(2)(g) requires the reporter to submit their preliminary comments with respect to the incident. The comments should include a discussion of the preliminary findings of the investigation and an assessment of the risk to patients/users. Section 60(2)(h) requires the reporter to submit their course of action in respect of the incident, including an investigation, that they propose to follow and a timetable for carrying out any proposed actions and for submitting a final report. This should also include a discussion of whether the device was repaired or replaced following the incident and the details of the repair or replacement, if available when submitting the preliminary report. Section 60(2)(i) requires the reporter to submit a statement concerning the submission of a previous report for the device and the date of that report.

This is interpreted to mean the last incident with the same root cause for the device. This statement should include both the reporter's and Health Canada's file number for that incident. The proposed interim correction(s) and corrective action(s) must reduce the risk of the device to patients, users and other people to acceptable levels. Proposed interim actions may include a temporary stop-sale or recall, including communication of information about the risk to all users. The situation should be monitored to confirm that the interim actions have reduced the risk to acceptable levels.

2.10.1.2 What criteria will Health Canada use to assess the adequacy of the proposed course of action and timetable?. In general, Health Canada will use the following criteria. Does the proposed course of action determine if the incident is device-related?. Does the proposed course of action determine if there is a systemic design defect, a quality control defect (lot-related), or a defect specific to that individual device?. Does the proposed timetable jeopardize the safety of other patients/users?.

Are there any unexplained gaps in the proposed timetable?. Are there any interim actions (for example. Safety alert, temporary stop-sale, interim design change) required to protect the safety of other patients/users while the investigation is under way?. Does the proposed course of action include an assessment of the risk (severity of hazard and frequency of occurrence)?. Does the proposed course of action include an analysis of previous similar incidents?.

Does the assessment of the health risk take all known relevant information into account?. Is it based on sound methodology and reasonable assumptions?. Is there a need to test samples of the device?. If so, has the manufacturer arranged testing?. Are the proposed test methods appropriate?.

2.10.1.3 What criteria will Health Canada use to assess the adequacy of the interim corrective actions proposed in the preliminary report?. In general, Health Canada will use the following criteria based on all information available. Is there a significant risk of death or serious injury without interim corrective action?. If so, will the proposed interim corrective action reduce the risk to other patients/users to acceptable levels (for example. To a remote chance of device-related death or serious deterioration in health)?.

Is there a need for a temporary stop-sale, or recall, including risk communication to users of the device?. If so, has the manufacturer proposed this action?. Does it appear from the plan of action that it would be timely and effective?. Will critical information about the risk be communicated to all users via alert letters, supplemental warnings, advisories, public announcements, media releases or other means?. Have the most timely, efficient and effective methods of communication been selected?.

Is the manufacturer adequately monitoring the situation to confirm that the interim actions have reduced the risk to an acceptable level?. 2.10.2 Final report The purpose of a final report is to inform Health Canada of, 1) the results and conclusions of the investigation, and 2) the corrective actions and preventive actions (as appropriate) that have been, or will be, undertaken. 2.10.2.1 What information must be submitted in the final report?. Section 61 of the Regulations sets out the information requirements for a final report. The required information is listed below by section number, with a brief explanation where necessary.

References made to the reporter, mean the reporter of the incident to Health Canada. Section 61(2)(a) requires the reporter to submit a description of the incident, including the number of persons who have experienced a serious deterioration in the state of their health or who have died. All new information obtained since the submission of the preliminary report must be included so that the description of the incident in the final report is unambiguous and complete. This would also include a discussion of whether the device was repaired or replaced following the submission of the preliminary report, and the details of the repair or replacement. Section 61(2)(b) requires the reporter to submit a detailed explanation of the root cause of the incident and a justification for the actions taken in respect of the incident.

The explanation should be clear, scientifically sound, and consistent with the data provided and other relevant available information. The justification should present evidence that the proposed course of action will resolve the problem and mitigate the risk of its recurrence. Note. If no corrective actions are to be undertaken, a detailed rationale must be included in the report. Section 61(2)(c) requires the reporter to submit any actions taken as a result of the investigation, which may include, (i) increased post-market surveillance of the device, (ii) corrective and preventive action respecting the design and manufacture of the device, and (iii) recall of the device.

Note. Section 61(2)(c)(ii) is interpreted to mean the following. Corrective action on the device to prevent recurrence of the issue respecting the design and manufacture of the device, and may also include preventive action taken on similar product lines / devices to prevent occurrence of the same issue. 2.10.2.1.1 Increased post-market surveillance If increased post-market surveillance is required, the final report must present an action plan for increased monitoring and trending of incidents associated with devices already on the market, including the following details. Which users will be monitored and by what method(s)?.

How long will the increased post-market surveillance continue?. The provisions for the timely reporting of the surveillance results to Health Canada. 2.10.2.1.2 Providing information to users of the device If there is a need to provide information to users of the device, the final report must include details of the risk communication plan. This may be done by referring, in the final report, to the recall notification which was already submitted to Health Canada. 2.10.2.1.3 Preventive action regarding the design and manufacture of the device Although the Regulations refer to preventive actions in section 61(2)(c)(ii), it should be noted that if an incident has occurred, it is not possible to take a preventive action.

The manufacturer should always look across its product lines to evaluate whether the issue that resulted in an incident with one product may also occur in another product line, if no action is taken. In this case, since the other product lines have not yet experienced the issue, any action taken is considered to be preventive. This is documented in the manufacturer's quality management system. It is not reported to Health Canada under the incident reporting provisions of the Regulations. 2.10.2.1.4 Corrections and corrective actions If a correction is required for any units of the device still in use, the final report should include a detailed action plan and timetable for carrying out the correction.

If the investigation indicates that there is a design or manufacturing defect, the final report must include a detailed plan of action and timetable to correct this defect and to prevent its recurrence. Note. Trending is not considered to be a corrective action, but is part of a post-market surveillance program. Corrections and corrective actions fall under recall activities. 2.10.2.2 What do I do if the device is not returned for evaluation?.

It should be noted that in the event a device is not returned for evaluation, an investigation into the root cause of the incident must still be conducted to the extent possible. This investigation may include the evaluation of retained samples from the same lot, and from earlier and later lots of production from the device in question, as well as the evaluation of all related or similar incident records for that lot, for example. 2.10.2.3 What criteria will Health Canada use to determine the adequacy of the final report?. In general, Health Canada will use the following criteria based on all information available. Is the description of the incident clear and complete?.

Is the explanation consistent with the data provided and other relevant, available information?. Does the evidence presented suggest that the proposed course of action will resolve the problem and mitigate its recurrence?. Do the corrective actions and preventive actions address problems with existing devices (for example. Units already on the market) and future devices, respectively?. 2.10.2.4 What criteria will Health Canada use to assess the adequacy of the actions taken?.

In general, Health Canada will use the following criteria based on all information available. If there is a design defect, is there reasonable evidence that the manufacturer's actions will correct it?. Will the device continue to be safe and effective after these actions?. If the problem concerns one or more defective lots, have these lots been recalled?. Have users been adequately notified of the risk associated with the defective device(s)?.

2.11 Inadequacies in reporting It should be noted that absences from an incident report of any elements outlined in this guidance document may necessitate additional questions, requests for information and compliance verifications by Health Canada. Submission of inadequate incident reports by reporters, for which Canada Vigilance - Medical Device Problem Reporting Program is consistently required to request additional information, will result in the forwarding of this information to the Health Products and Food Branch Inspectorate, to determine regulatory compliance. 2.12 Follow-up activities If there are any questions relating to the device or the incident in the report, Health Canada will contact the reporter/manufacturer/importer listed on the incident report. 2.13 What is the process for submission of an incident report to Health Canada?. Incident reports may be submitted to Health Canada using one of the following methods.

E-mail. Although Health Canada accepts reports submitted by mail/courier, facsimile, and email, the preference is that they be submitted by email (hc.mdpr-dimm.sc@canada). In order to receive an automated response acknowledging receipt of your report, you must include the acronym "MDPR" in the subject line of the email. Facsimile. Reports may be submitted by facsimile to 613-954-0941.

Mail. Reports may be submitted by postal mail or courier to the following address. Canada Vigilance - Medical Device Problem Reporting Program Marketed Health Products Directorate Health Canada Address Locator 0701E 200 Tunney's Pasture Driveway Ottawa, Ontario K1A 0K9 Once the report has been received and entered into our database, a letter confirming receipt of the report will be sent to the reporter. This letter will contain information concerning the name of the device in the incident, the reporter's file number, Health Canada's file number and the date the report was received by Health Canada. Please ensure that Health Canada's file number and the Reporter file number is included on all further correspondence concerning the incident.

Appendix A. Examples of Potential Use Error and Potential Abnormal Use A.1 Potential use errors Complaint reports received of incidents occurring despite adequate instructions and design according to manufacturer's analysis. Examples include the following. User presses the wrong button. User misinterprets the icon and selects the wrong function.

User enters incorrect sequence and fails to initiate infusion. User fails to detect a dangerous increase in heart rate because they have set the alarm limit too high and user is over-reliant on the device's alarm system. User cracks catheter connector when tightening. A centrifugal pump is made from material that is known to be incompatible with alcohol according to the labelling, marking, and product warnings provided with the pump. Some pumps are found to have cracked owing to inadvertent cleaning with alcohol.

Unintentional use of pipette out of calibration range. Analyzer placed in direct sunlight causing higher reaction temperature than specified. MRI system and suite have large orange warning labels concerning bringing metal near the magnet. Technician brings an oxygen tank into presence of magnet and it moves swiftly across the room into the magnet. A.2 Potential abnormal uses Potential abnormal uses include complaint reports received of incidents occurring despite proper instructions.

Proper design. Or proper training, and are, according to manufacturer's analysis, determined to be beyond any reasonable means of the manufacturer's risk control. Examples include the following. Use of a medical device during installation, prior to completing all initial performance checks as specified by the manufacturer. Failure to conduct device checks prior to each use as defined by the manufacturer.

Continued use of a medical device beyond the manufacturer-defined, planned maintenance interval as a result of user's failure to arrange for maintenance. Pacemaker showed no output after use of electrocautery device on the patient, despite appropriate warnings. Product analysis showed that the device was working in accordance with specifications. Further investigation revealed that the user was inadequately trained due to failure to obtain proper training. During the placement of a pacemaker lead, an inexperienced physician or other non-qualified individual perforates the heart.

The labelling for a centrifugal pump clearly indicates that it is intended for use in by-pass operations of less than 6 hours duration. After considering the pump options, a clinician decides that the pump will be used in paediatric extra-corporeal membrane oxygenation (ECMO) procedures, most of which may last several days. A pump fails due to fatigue cracking and patient bled to death. Safety interlock on a medical laser removed by the user. Filter removed, and intentionally not replaced, resulting in particulate contamination and subsequent device failure.

Tanks delivered to a health care facility are supposed to contain oxygen but have nitrogen in them with nitrogen fittings. The maintenance person at the health care facility is instructed to make them fit the oxygen receptacles. Nitrogen is delivered by mistake resulting in several serious injuries. Use of an automated analyzer regardless of the warnings on the screen that calibration is to be verified. Pacemaker-dependant patient placed in a MRI system with the knowledge of the physician.

Ventilator alarm is disabled, preventing detection of risk condition..

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As part of this project, the Peterborough Police Service is working with local partners to create a community-based outreach team to increase the what is in kamagra capacity for front-line community services to help people https://kingdomconnection.eu/buy-flagyl-online-cheap/ at risk who are referred by police. With the help of this new team, people who use drugs or experience mental health issues will be redirected from the criminal justice system to harm reduction, peer support, health and social services. Additionally, this initiative will increase access to culturally appropriate services for Indigenous Peoples, LGBTQ2+ populations, youth, women, and those living with HIV through partnerships with other organizations such as Nogojiwanong Friendship Centre and Peterborough AIDS Research Network. The Government of Canada is committed to working with partners, peer workers, people with lived and living experience and other stakeholders to ensure Canadians receive the support they need to reduce the what is in kamagra harms related to substance use.Notice – Release of ICH M9. Biopharmaceutics Classification System (BCS) Based Biowaivers August 26, 2020Our file number.

20-109235-116 Health Canada is pleased to announce the implementation of International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) Guidance M9. Biopharmaceutics Classification System (BCS) Based Biowaivers what is in kamagra. This guidance has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. The ICH Assembly has endorsed the final draft and recommended its implementation by membership of ICH. In implementing the ICH M9 guideline, it replaces the Health Canada what is in kamagra guidance document.

Biopharmaceutics Classification System Based Biowaiver. It is recommended that the Health Canada BCS Based Biowaiver Evaluation Template be completed for drug submissions that include a biowaiver request. As per its commitment to ICH as a standing member, Health Canada is implementing this guidance with what is in kamagra no modifications. In implementing this ICH guidance, Health Canada endorses the principles and practices described therein. This document should be read in conjunction with this accompanying notice and with the relevant sections of other applicable Health Canada guidances.

This and what is in kamagra other Guidance documents are available on the ICH Website. Please note that the ICH website is only available in English. If you would like to request a copy of the French version of the document, please contact the HPFB ICH inbox. Should you have any questions or comments regarding what is in kamagra the content of the guidance, please contact. Health Canada - ICH CoordinatorE-mail.

HPFB_ICH_DGPSA@hc-sc.gc.caDate published. August 26, 2020On what is in kamagra this page Backgrounderectile dysfunction treatment is an infectious disease caused by the erectile dysfunction erectile dysfunction. The World Health Organization declared a global kamagra in March 2020, and the Minister of Health signed the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to erectile dysfunction treatment on March 18, 2020. The Interim Order (IO) allows us to quickly address large-scale public health emergencies.This IO allows for faster authorization of Class I-IV medical devices for erectile dysfunction treatment.This document presents the criteria for safety and effectiveness that apply to test swabs used for erectile dysfunction treatment sampling. It also provides guidance on how to meet these criteria in an what is in kamagra application under the IO pathway.

Diagnostic testing is a key element in both. identifying cases of preventing the spread of the erectile dysfunction A test swab may be used to collect a sample for either Polymerase Chain Reaction (PCR) laboratory testing or point-of-care testing. Point-of-care testing can be done directly in a hospital or doctor’s what is in kamagra office. Once the sample has been taken, the swab is either placed in a preserving liquid and sent to a laboratory for testing, or placed directly in a testing device (point-of-care).Swabs may be packaged in a variety of kamagra transport media (VTM). Specifications for individual VTMs are beyond the scope of this document.

Swabs play a role in what is in kamagra the accuracy of erectile dysfunction treatment diagnostic testing. For example, false negatives can occur in PCR tests if. the swab material inhibits the test reaction or the swab design doesn’t provide enough surface area to obtain a sufficient sample Test swabs that are not safe and effective may cause or lead to harm. For example what is in kamagra. A swab that breaks during sample collection can cause physical injury a non-sterile swab that produces an incorrect test result can lead to harmHealth Canada has published a guidance document to support the preparation of applications submitted under the IO.

It should be read in conjunction with this document. We are processing applications as quickly what is in kamagra as possible. To avoid delays, please ensure you have completed your application properly.Medical Devices Regulations (MDR) classification In the Canadian regulatory framework, Class I devices present the lowest potential risk and Class IV the highest. Swabs are classified according to their labelling and intended use. For example, if a swab is labelled for nasopharyngeal (NP) what is in kamagra or oropharyngeal (OP) use only, it will be classified as a Class I medical device according to Classification Rule 2(2) of the MDR.

If a swab is not exclusively for use in oral or nasal cavities, or its use is not explicitly stated, it will be classified as a Class II device by Rule 2(1). These swabs belong to a higher risk class because their use in other body orifices for the collection of tissue samples (for example, to test for chlamydia or ureaplasma) is associated with greater risk. Rule 2 Subject to subrules (2) to (4), all invasive devices that penetrate the body through a body orifice or that come into contact with the surface of the eye are classified as what is in kamagra Class II. A device described in subrule (1) that is intended to be placed in the oral or nasal cavities as far as the pharynx or in the ear canal up to the ear drum is classified as Class I.Regulatory pathways for erectile dysfunction treatment devicesManufacturers of Class I swabs may seek authorization to import and sell their products under either. A Medical Device Establishment Licence (MDEL) MDEL is an establishment oversight framework that is not product-specific and not designed to assess safety and effectiveness an IO authorization information on safety and effectiveness are required as part of the application Health Canada is encouraging a sub-group of swab manufacturers to use the IO authorization pathway for Class I swabs, especially if they are.

New to the manufacturing of swabs and manufacturing in Canada what is in kamagra (such as a company that has re-tooled to manufacture), or using a new manufacturing process or design for swabs (such as 3D printing or honeycomb design)IO applications for swabs should include the following information.Device description The device description should include. A picture and/or engineering drawing identification of all materials used in the production of the swab the intended use(s) (for example, NP swabs)Quality manufacturingManufacturers must either. demonstrate compliance with Quality Manufacturing Systems (for example, ISO 13485 certificate) applicable to the swab, or provide a clear description of the planned quality manufacturing systems that are consistent with similar existing manufacturing systemsDesign verificationProvide swab design verification (bench testing) data in a summary report. It should show what is in kamagra that the essential minimum design characteristics are met. These data should be based on test samples representative of finished swabs that have undergone sterilization prior to bench testing.Dimensions Swabs should have minimum length specifications and minimum and maximum head diameter specifications in order to be safe and effective.

Minimum length specification for example, adult NP swabs require ≥14 cm to reach the posterior nasopharynx minimum and maximum head diameter specification for example, adult NP swabs require 1–4 mm to pass into the mid-inferior portion of the inferior turbinate and maneuver well FlexibilitySwab flexibility is assessed through. Durability for example, tolerate 20 what is in kamagra rough repeated insertions into a 4 mm inner diameter clear plastic tube curved back on itself with a curve radius of 3 cm bendability for example, bend tip and neck 90º without breaking ability to maintain initial form for example, restore to initial form following 45º bending Manufacturers may describe the test performed, the number of samples, and a summary of the results.Strength/Breakpoint (failure) To limit the potential for patient harm, the minimum breakpoint distance should be approximately 8 to 9 cm from the nasopharynx. However, no breaks or fractures should occur following reasonable manipulation. Applicants should submit a rationale for the design of the breakpoint distance from the swab tip. It should demonstrate that the breakpoint length can be accommodated by commercially available swab/media tubes.Surface propertiesThe what is in kamagra swab surface should be free of.

processing aids (such as disinfectants) foreign materials degreasers mold release agents For injection molded swabs, no burrs, flashing, or sharp edges should be present. Design validationProvide swab validation (performance) data in a summary report that demonstrates that the swab. can acquire samples comparable to a what is in kamagra commercially available swab control, and will not inhibit the PCR reactionThese data should be based on test samples representative of finished swabs that have undergone sterilization prior to testing.Comparable sample acquisition to a control, and PCR compatibilityThe manufacturer should demonstrate test swab cycle threshold (Ct) recovery values (RT-PCR) that are statistically comparable to those obtained from a commercially available swab control using erectile dysfunction (or a scientifically justified surrogate).Pass/Fail criteria. Values ≥ 2Cts indicate significantly less efficient ribonucleic acid collection and/or elution.Clinical feasibility/suitability simulationManufacturers should submit either. A clinical test report or previous clinical data Clinical test reportThe clinical test report should describe the use of the proposed finished swab (sterilized) in a sufficient number of individuals by trained healthcare professionals in a minimum of 30 patients that have tested positive for erectile dysfunction, or a scientifically justified surrogate kamagra.

Include comparisons of the proposed swab against a flocked swab commercially available in Canada with respect what is in kamagra to. flexibility fit ability to navigate to the nasopharynx (or other areas specified in the indications) ability to collect a specimen/respiratory epithelial cells for example, using the RNase P housekeeping gene test results agreement for example, ≥ 90% positive % agreement using a composite control (positive % agreement calculation that includes all positive findings from control and test swabs) Clinical testing considerations A scientifically justified surrogate kamagra may be used if erectile dysfunction treatment-positive patients are not available. Positive % agreement should not be determined using high Ct samples. One-half (1/2) to two-thirds (2/3) what is in kamagra of erectile dysfunction treatment-positive samples should have a high viral loads (Cts <. 30).

Report agreement between control and test swabs in terms of quantitative (Ct) and qualitative (+/- test) values with appropriate descriptive statistics. Include patient symptomatology for samples what is in kamagra. For example, days from symptom onset, known vs. Suspected erectile dysfunction treatment status. Use of different VTM/universal transport media (V/UTM) across erectile dysfunction treatment-positive samples may contribute to Ct what is in kamagra variability.

Ensure consistency by using the same media/tubes for each specimen within a clinical evaluation. Validate the chosen V/UTM media/tubes to show they will not interfere with the PCR test results. For example, allowing 7 days of swab positive what is in kamagra specimen incubation with the chosen media/vial is considered a worst-case transportation scenario to evaluate maximal leaching/interaction potential). Use a single PCR test platform throughout each clinical evaluation. The platform should have been previously authorized by HC or another jurisdiction.

Location (for example, left vs right nostril) and order what is in kamagra of sampling (for example, control vs. Test swab) can affect specimen quality and results variability. Location and swab sampling order should be randomized.For additional information on collecting, handling, and testing erectile dysfunction treatment specimens, please refer to the Centers for Disease Control and Prevention (CDC) Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens for erectile dysfunction treatment.Previous clinical dataPreviously obtained clinical data may be submitted in lieu of clinical testing. Those data should demonstrate the safe and effective use of a swab of identical design and materials in human what is in kamagra subjects. The proposed swab should be compared against a flocked swab commercially available in Canada with respect to.

flexibility fit ability to navigate to the nasopharynx (or other areas specified in the indications) ability to collect a specimen/respiratory epithelial cells for example, using the RNase P housekeeping gene test results agreement for example, ≥ 90% positive % agreement) using a composite control (positive % agreement calculation that includes all positive findings from control and test swabs) Sterility Provide sterilization validation data in a summary report. It should demonstrate that the chosen sterilization method will achieve a minimum Sterility Assurance Level (SAL) of 10-6 for the proposed swab, using an what is in kamagra appropriate biological indicator (BI) organism (see below). If the swab will be sterilized using an ethylene oxide (EtO) method, you should demonstrate that EtO and ethylene chlorohydrin (ECH) residuals meet the tolerable contact limits (TCL) specified in ISO 10993-7. Commonly used swab materials, compatible sterilization methods, and appropriate biological indicators are described below. Sterilization Method Swab Materials EtO(for example, ISO 11135) Gamma Irradiation(ISO 11137) Polystyrene handle, polyester bicomponent fiber tipFootnote * X(for example, Puritan 25-3316-H/U) Not applicable what is in kamagra Polystyrene handle, nylon flocked fiber tipFootnote * X(for example, Copan 503CS01) X(for example, BD 220252) Footnote * The CDC provides guidance on the types of swabs that should be used for optimal specimen collection for PCR testing.

They include swabs that are made of polyester (for example, Dacron), rayon, or nylon-flocked. Cotton-tipped or calcium alginate swabs are not acceptable because residues present in those materials inhibit the PCR reaction. Return to footnote * referrer Appropriate BIIf ionizing radiation will be what is in kamagra used to sterilize the swab. Bacillus pumilus spores are recommended for doses of 25 kGy Bacillus cereus or Bacillus sphaericus spores are recommended for doses of >. 25 kGy (World Health Organization, The International Pharmacopoeia, 9th Ed., 2019) Sterilization Process Spore (Indicator Organism) Steam Geobacillus stearothermophilus(formerly Bacillus stearothermophilus) Dry Heat Bacillus atrophaeus (formerly Bacillus subtilis var.

Niger) Ethlylene Oxide Bacillus atrophaeus what is in kamagra (formerly Bacillus subtilis var. Niger) Hydrogen Peroxide Geobacillus stearothermophilus(formerly Bacillus stearothermophilus) Source. US Food and Drug Administration, "Biological Indicator (BI) Premarket Notification [510(k)] Submissions," October 2007. [Online].Packaging validation Provide packaging what is in kamagra validation data in a summary report. It should demonstrate that the swab packaging system will maintain a sterile environment across the labelled shelf life (for example, ASTM F1980).

without leakage (for example, ASTM D3078-02) with adequate seal strength (for example, ASTM F88/EN 868-5)Test packaging samples should be representative of finished swab packages that have undergone sterilization prior to testing.Biocompatibility Provide biocompatibility data in a summary report. It should demonstrate compliance with biocompatibility tests recommended for devices in limited contact (≤24 hrs) with mucosal membranes, as per ISO 10993-1. These include. cytotoxicity sensitization irritation/intracutaneous reactivityThese data should be based on test samples representative of finished swabs that have undergone sterilization prior to testing.LabellingSwabs should be individually packaged and labelled. The application must include the swab label, which must include.

As part of this project, the Peterborough Police Service is working with local partners to create a community-based outreach team to increase the capacity for front-line community services to help people buy kamagra oral jelly wholesale at risk who are referred by police. With the help of this new team, people who use drugs or experience mental health issues will be redirected from the criminal justice system to harm reduction, peer support, health and social services. Additionally, this initiative will increase access to culturally appropriate services for Indigenous Peoples, LGBTQ2+ populations, youth, women, and those living with HIV through partnerships with other organizations such as Nogojiwanong Friendship Centre and Peterborough AIDS Research Network. The Government of Canada is committed to working with partners, peer workers, people with lived and living experience and other stakeholders to ensure Canadians receive the support they need to reduce buy kamagra oral jelly wholesale the harms related to substance use.Notice – Release of ICH M9.

Biopharmaceutics Classification System (BCS) Based Biowaivers August 26, 2020Our file number. 20-109235-116 Health Canada is pleased to announce the implementation of International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) Guidance M9. Biopharmaceutics Classification System (BCS) Based buy kamagra oral jelly wholesale Biowaivers. This guidance has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process.

The ICH Assembly has endorsed the final draft and recommended its implementation by membership of ICH. In implementing the buy kamagra oral jelly wholesale ICH M9 guideline, it replaces the Health Canada guidance document. Biopharmaceutics Classification System Based Biowaiver. It is recommended that the Health Canada BCS Based Biowaiver Evaluation Template be completed for drug submissions that include a biowaiver request.

As per buy kamagra oral jelly wholesale its commitment to ICH as a standing member, Health Canada is implementing this guidance with no modifications. In implementing this ICH guidance, Health Canada endorses the principles and practices described therein. This document should be read in conjunction with this accompanying notice and with the relevant sections of other applicable Health Canada guidances. This and other Guidance documents are available on buy kamagra oral jelly wholesale the ICH Website.

Please note that the ICH website is only available in English. If you would like to request a copy of the French version of the document, please contact the HPFB ICH inbox. Should you buy kamagra oral jelly wholesale have any questions or comments regarding the content of the guidance, please contact. Health Canada - ICH CoordinatorE-mail.

HPFB_ICH_DGPSA@hc-sc.gc.caDate published. August 26, 2020On this page Backgrounderectile dysfunction treatment buy kamagra oral jelly wholesale is an infectious disease caused by the erectile dysfunction erectile dysfunction. The World Health Organization declared a global kamagra in March 2020, and the Minister of Health signed the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to erectile dysfunction treatment on March 18, 2020. The Interim Order (IO) allows us to quickly address large-scale public health emergencies.This IO allows for faster authorization of Class I-IV medical devices for erectile dysfunction treatment.This document presents the criteria for safety and effectiveness that apply to test swabs used for erectile dysfunction treatment sampling.

It also provides guidance on how to meet these criteria in an application under the IO buy kamagra oral jelly wholesale pathway. Diagnostic testing is a key element in both. identifying cases of preventing the spread of the erectile dysfunction A test swab may be used to collect a sample for either Polymerase Chain Reaction (PCR) laboratory testing or point-of-care testing. Point-of-care testing can be buy kamagra oral jelly wholesale done directly in a hospital or doctor’s office.

Once the sample has been taken, the swab is either placed in a preserving liquid and sent to a laboratory for testing, or placed directly in a testing device (point-of-care).Swabs may be packaged in a variety of kamagra transport media (VTM). Specifications for individual VTMs are beyond the scope of this document. Swabs play buy kamagra oral jelly wholesale a role in the accuracy of erectile dysfunction treatment diagnostic testing. For example, false negatives can occur in PCR tests if.

the swab material inhibits the test reaction or the swab design doesn’t provide enough surface area to obtain a sufficient sample Test swabs that are not safe and effective may cause or lead to harm. For example buy kamagra oral jelly wholesale. A swab that breaks during sample collection can cause physical injury a non-sterile swab that produces an incorrect test result can lead to harmHealth Canada has published a guidance document to support the preparation of applications submitted under the IO. It should be read in conjunction with this document.

We are processing applications as quickly buy kamagra oral jelly wholesale as possible. To avoid delays, please ensure you have completed your application properly.Medical Devices Regulations (MDR) classification In the Canadian regulatory framework, Class I devices present the lowest potential risk and Class IV the highest. Swabs are classified according to their labelling and intended use. For example, if a swab is labelled for nasopharyngeal (NP) buy kamagra oral jelly wholesale or oropharyngeal (OP) use only, it will be classified as a Class I medical device according to Classification Rule 2(2) of the MDR.

If a swab is not exclusively for use in oral or nasal cavities, or its use is not explicitly stated, it will be classified as a Class II device by Rule 2(1). These swabs belong to a higher risk class because their use in other body orifices for the collection of tissue samples (for example, to test for chlamydia or ureaplasma) is associated with greater risk. Rule 2 Subject to subrules (2) to (4), all invasive devices that penetrate the body through a body orifice or that buy kamagra oral jelly wholesale come into contact with the surface of the eye are classified as Class II. A device described in subrule (1) that is intended to be placed in the oral or nasal cavities as far as the pharynx or in the ear canal up to the ear drum is classified as Class I.Regulatory pathways for erectile dysfunction treatment devicesManufacturers of Class I swabs may seek authorization to import and sell their products under either.

A Medical Device Establishment Licence (MDEL) MDEL is an establishment oversight framework that is not product-specific and not designed to assess safety and effectiveness an IO authorization information on safety and effectiveness are required as part of the application Health Canada is encouraging a sub-group of swab manufacturers to use the IO authorization pathway for Class I swabs, especially if they are. New to the manufacturing of swabs and manufacturing in Canada (such as a company that has re-tooled to manufacture), or using a new manufacturing process or design buy kamagra oral jelly wholesale for swabs (such as 3D printing or honeycomb design)IO applications for swabs should include the following information.Device description The device description should include. A picture and/or engineering drawing identification of all materials used in the production of the swab the intended use(s) (for example, NP swabs)Quality manufacturingManufacturers must either. demonstrate compliance with Quality Manufacturing Systems (for example, ISO 13485 certificate) applicable to the swab, or provide a clear description of the planned quality manufacturing systems that are consistent with similar existing manufacturing systemsDesign verificationProvide swab design verification (bench testing) data in a summary report.

It should buy kamagra oral jelly wholesale show that the essential minimum design characteristics are met. These data should be based on test samples representative of finished swabs that have undergone sterilization prior to bench testing.Dimensions Swabs should have minimum length specifications and minimum and maximum head diameter specifications in order to be safe and effective. Minimum length specification for example, adult NP swabs require ≥14 cm to reach the posterior nasopharynx minimum and maximum head diameter specification for example, adult NP swabs require 1–4 mm to pass into the mid-inferior portion of the inferior turbinate and maneuver well FlexibilitySwab flexibility is assessed through. Durability for example, tolerate 20 rough repeated insertions into a 4 mm inner diameter clear plastic tube curved back on itself with a curve radius of 3 cm bendability for example, bend tip and neck 90º without breaking ability to maintain initial form for example, restore to initial form following 45º bending Manufacturers may describe the test performed, the number of samples, and a summary of the results.Strength/Breakpoint (failure) To limit the potential for patient harm, the buy kamagra oral jelly wholesale minimum breakpoint distance should be approximately 8 to 9 cm from the nasopharynx.

However, no breaks or fractures should occur following reasonable manipulation. Applicants should submit a rationale for the design of the breakpoint distance from the swab tip. It should buy kamagra oral jelly wholesale demonstrate that the breakpoint length can be accommodated by commercially available swab/media tubes.Surface propertiesThe swab surface should be free of. processing aids (such as disinfectants) foreign materials degreasers mold release agents For injection molded swabs, no burrs, flashing, or sharp edges should be present.

Design validationProvide swab validation (performance) data in a summary report that demonstrates that the swab. can acquire samples comparable to a commercially available swab control, and will not inhibit the PCR reactionThese data should be based on test samples representative of finished swabs that have undergone sterilization prior to testing.Comparable sample acquisition to a control, and PCR compatibilityThe manufacturer should demonstrate test swab cycle threshold (Ct) recovery values (RT-PCR) that are statistically comparable to those obtained from buy kamagra oral jelly wholesale a commercially available swab control using erectile dysfunction (or a scientifically justified surrogate).Pass/Fail criteria. Values ≥ 2Cts indicate significantly less efficient ribonucleic acid collection and/or elution.Clinical feasibility/suitability simulationManufacturers should submit either. A clinical test report or previous clinical data Clinical test reportThe clinical test report should describe the use of the proposed finished swab (sterilized) in a sufficient number of individuals by trained healthcare professionals in a minimum of 30 patients that have tested positive for erectile dysfunction, or a scientifically justified surrogate kamagra.

Include comparisons buy kamagra oral jelly wholesale of the proposed swab against a flocked swab commercially available in Canada with respect to. flexibility fit ability to navigate to the nasopharynx (or other areas specified in the indications) ability to collect a specimen/respiratory epithelial cells for example, using the RNase P housekeeping gene test results agreement for example, ≥ 90% positive % agreement using a composite control (positive % agreement calculation that includes all positive findings from control and test swabs) Clinical testing considerations A scientifically justified surrogate kamagra may be used if erectile dysfunction treatment-positive patients are not available. Positive % agreement should not be determined using high Ct samples. One-half (1/2) to two-thirds (2/3) of erectile dysfunction treatment-positive samples should have a high viral loads (Cts buy kamagra oral jelly wholesale <.

30). Report agreement between control and test swabs in terms of quantitative (Ct) and qualitative (+/- test) values with appropriate descriptive statistics. Include patient symptomatology buy kamagra oral jelly wholesale for samples. For example, days from symptom onset, known vs.

Suspected erectile dysfunction treatment status. Use of buy kamagra oral jelly wholesale different VTM/universal transport media (V/UTM) across erectile dysfunction treatment-positive samples may contribute to Ct variability. Ensure consistency by using the same media/tubes for each specimen within a clinical evaluation. Validate the chosen V/UTM media/tubes to show they will not interfere with the PCR test results.

For example, allowing 7 days of swab positive specimen incubation with the chosen media/vial is considered a worst-case transportation buy kamagra oral jelly wholesale scenario to evaluate maximal leaching/interaction potential). Use a single PCR test platform throughout each clinical evaluation. The platform should have been previously authorized by HC or another jurisdiction. Location (for example, left vs right nostril) buy kamagra oral jelly wholesale and order of sampling (for example, control vs.

Test swab) can affect specimen quality and results variability. Location and swab sampling order should be randomized.For additional information on collecting, handling, and testing erectile dysfunction treatment specimens, please refer to the Centers for Disease Control and Prevention (CDC) Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens for erectile dysfunction treatment.Previous clinical dataPreviously obtained clinical data may be submitted in lieu of clinical testing. Those data should demonstrate the safe and effective use of a swab of identical design and materials buy kamagra oral jelly wholesale in human subjects. The proposed swab should be compared against a flocked swab commercially available in Canada with respect to.

flexibility fit ability to navigate to the nasopharynx (or other areas specified in the indications) ability to collect a specimen/respiratory epithelial cells for example, using the RNase P housekeeping gene test results agreement for example, ≥ 90% positive % agreement) using a composite control (positive % agreement calculation that includes all positive findings from control and test swabs) Sterility Provide sterilization validation data in a summary report. It should demonstrate that the chosen sterilization method will achieve a minimum Sterility Assurance Level (SAL) of 10-6 buy kamagra oral jelly wholesale for the proposed swab, using an appropriate biological indicator (BI) organism (see below). If the swab will be sterilized using an ethylene oxide (EtO) method, you should demonstrate that EtO and ethylene chlorohydrin (ECH) residuals meet the tolerable contact limits (TCL) specified in ISO 10993-7. Commonly used swab materials, compatible sterilization methods, and appropriate biological indicators are described below.

Sterilization Method Swab Materials EtO(for example, ISO 11135) buy kamagra oral jelly wholesale Gamma Irradiation(ISO 11137) Polystyrene handle, polyester bicomponent fiber tipFootnote * X(for example, Puritan 25-3316-H/U) Not applicable Polystyrene handle, nylon flocked fiber tipFootnote * X(for example, Copan 503CS01) X(for example, BD 220252) Footnote * The CDC provides guidance on the types of swabs that should be used for optimal specimen collection for PCR testing. They include swabs that are made of polyester (for example, Dacron), rayon, or nylon-flocked. Cotton-tipped or calcium alginate swabs are not acceptable because residues present in those materials inhibit the PCR reaction. Return to footnote * referrer Appropriate BIIf ionizing radiation will be used to sterilize buy kamagra oral jelly wholesale the swab.

Bacillus pumilus spores are recommended for doses of 25 kGy Bacillus cereus or Bacillus sphaericus spores are recommended for doses of >. 25 kGy (World Health Organization, The International Pharmacopoeia, 9th Ed., 2019) Sterilization Process Spore (Indicator Organism) Steam Geobacillus stearothermophilus(formerly Bacillus stearothermophilus) Dry Heat Bacillus atrophaeus (formerly Bacillus subtilis var. Niger) buy kamagra oral jelly wholesale Ethlylene Oxide Bacillus atrophaeus (formerly Bacillus subtilis var. Niger) Hydrogen Peroxide Geobacillus stearothermophilus(formerly Bacillus stearothermophilus) Source.

US Food and Drug Administration, "Biological Indicator (BI) Premarket Notification [510(k)] Submissions," October 2007. [Online].Packaging validation Provide packaging validation buy kamagra oral jelly wholesale data in a summary report. It should demonstrate that the swab packaging system will maintain a sterile environment across the labelled shelf life (for example, ASTM F1980). without leakage (for example, ASTM D3078-02) with adequate seal strength (for example, ASTM F88/EN 868-5)Test packaging samples should be representative of finished swab packages that have undergone sterilization prior to testing.Biocompatibility Provide biocompatibility data in a summary report.

It should demonstrate compliance with buy kamagra oral jelly wholesale biocompatibility tests recommended for devices in limited contact (≤24 hrs) with mucosal membranes, as per ISO 10993-1. These include. cytotoxicity sensitization irritation/intracutaneous reactivityThese data should be based on test samples representative of finished swabs that have undergone sterilization prior to testing.LabellingSwabs should be individually packaged and labelled. The application must include the swab label, which must include.

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If you notice any changes in your vision while taking this drug, call your doctor or health care professional as soon as possible. Call your health care provider right away if you have any change in vision. Contact you doctor or health care professional right away if the erection lasts longer than 4 hours or if it becomes painful. This may be a sign of a serious problem and must be treated right away to prevent permanent damage. If you experience symptoms of nausea, dizziness, chest pain or arm pain upon initiation of sexual activity after taking Kamagra, you should refrain from further activity and call your doctor or health care professional as soon as possible. Using Kamagra does not protect you or your partner against HIV (the kamagra that causes AIDS) or other sexually transmitted diseases.

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NCHS Data thailand kamagra have a peek at this web-site Brief No. 286, September 2017PDF Versionpdf icon (374 KB)Anjel Vahratian, Ph.D.Key findingsData from the National Health Interview Survey, 2015Among those aged 40–59, perimenopausal women (56.0%) were more likely than postmenopausal (40.5%) and premenopausal (32.5%) women to sleep less than 7 hours, on average, in a 24-hour period.Postmenopausal women aged 40–59 were more likely than premenopausal women aged 40–59 to have trouble falling asleep (27.1% compared with 16.8%, respectively), and staying asleep (35.9% compared with 23.7%), four times or more in the past week.Postmenopausal women aged 40–59 (55.1%) were more likely than premenopausal women aged 40–59 (47.0%) to not wake up feeling well rested 4 days or more in the past week.Sleep duration and quality are important contributors to health and wellness. Insufficient sleep is associated with an increased risk for chronic conditions thailand kamagra such as cardiovascular disease (1) and diabetes (2). Women may be particularly vulnerable to sleep problems during times of reproductive hormonal change, such as after the menopausal transition. Menopause is “the permanent cessation of menstruation thailand kamagra that occurs after the loss of ovarian activity” (3).

This data brief describes sleep duration and sleep quality among nonpregnant women aged 40–59 by menopausal status. The age range selected for this analysis reflects the focus on midlife sleep health. In this analysis, 74.2% of women are premenopausal, 3.7% thailand kamagra are perimenopausal, and 22.1% are postmenopausal. Keywords. Insufficient sleep, menopause, National Health Interview Survey Perimenopausal women were more likely than premenopausal and postmenopausal women to sleep less than 7 hours, on average, in a 24-hour thailand kamagra period.More than one in three nonpregnant women aged 40–59 slept less than 7 hours, on average, in a 24-hour period (35.1%) (Figure 1).

Perimenopausal women were most likely to sleep less than 7 hours, on average, in a 24-hour period (56.0%), compared with 32.5% of premenopausal and 40.5% of postmenopausal women. Postmenopausal women were significantly more likely than premenopausal women to sleep less than 7 hours, on average, in a 24-hour period. Figure 1 thailand kamagra. Percentage of nonpregnant women aged 40–59 who slept less than 7 hours, on average, in a 24-hour period, by menopausal status. United States, 2015image icon1Significant quadratic thailand kamagra trend by menopausal status (p <.

0.05).NOTES. Women were postmenopausal if they had gone without a menstrual cycle for more than 1 year or were in surgical menopause after the removal of their ovaries. Women were perimenopausal if thailand kamagra they no longer had a menstrual cycle and their last menstrual cycle was 1 year ago or less. Women were premenopausal if they still had a menstrual cycle. Access data table for thailand kamagra Figure 1pdf icon.SOURCE.

NCHS, National Health Interview Survey, 2015. The percentage thailand kamagra of women aged 40–59 who had trouble falling asleep four times or more in the past week varied by menopausal status.Nearly one in five nonpregnant women aged 40–59 had trouble falling asleep four times or more in the past week (19.4%) (Figure 2). The percentage of women in this age group who had trouble falling asleep four times or more in the past week increased from 16.8% among premenopausal women to 24.7% among perimenopausal and 27.1% among postmenopausal women. Postmenopausal women were significantly more likely than premenopausal women to have trouble falling asleep four times or more in the past week. Figure 2 thailand kamagra.

Percentage of nonpregnant women aged 40–59 who had trouble falling asleep four times or more in the past week, by menopausal status. United States, 2015image thailand kamagra icon1Significant linear trend by menopausal status (p <. 0.05).NOTES. Women were postmenopausal if they had gone without a menstrual cycle for more than 1 year or were in surgical menopause after the removal of their ovaries. Women were perimenopausal if they no thailand kamagra longer had a menstrual cycle and their last menstrual cycle was 1 year ago or less.

Women were premenopausal if they still had a menstrual cycle. Access data table thailand kamagra for Figure 2pdf icon.SOURCE. NCHS, National Health Interview Survey, 2015. The percentage of women aged 40–59 who had trouble staying asleep four times or more in thailand kamagra the past week varied by menopausal status.More than one in four nonpregnant women aged 40–59 had trouble staying asleep four times or more in the past week (26.7%) (Figure 3). The percentage of women aged 40–59 who had trouble staying asleep four times or more in the past week increased from 23.7% among premenopausal, to 30.8% among perimenopausal, and to 35.9% among postmenopausal women.

Postmenopausal women were significantly more likely than premenopausal women to have trouble staying asleep four times or more in the past week. Figure 3 thailand kamagra. Percentage of nonpregnant women aged 40–59 who had trouble staying asleep four times or more in the past week, by menopausal status. United States, thailand kamagra 2015image icon1Significant linear trend by menopausal status (p <. 0.05).NOTES.

Women were postmenopausal if they had gone without a menstrual cycle for more than 1 year or were in surgical menopause after the removal of their ovaries. Women were perimenopausal if they thailand kamagra no longer had a menstrual cycle and their last menstrual cycle was 1 year ago or less. Women were premenopausal if they still had a menstrual cycle. Access data table for Figure thailand kamagra 3pdf icon.SOURCE. NCHS, National Health Interview Survey, 2015.

The percentage of women aged 40–59 who did not wake up feeling well rested 4 days or more in the past week varied by menopausal status.Nearly one in two nonpregnant women aged 40–59 did not wake up feeling well rested 4 days or more in the past week (48.9%) (Figure 4). The percentage of women in this age group who did not wake up feeling well rested 4 days or more in the thailand kamagra past week increased from 47.0% among premenopausal women to 49.9% among perimenopausal and 55.1% among postmenopausal women. Postmenopausal women were significantly more likely than premenopausal women to not wake up feeling well rested 4 days or more in the past week. Figure 4 thailand kamagra. Percentage of nonpregnant women aged 40–59 who did not wake up feeling well rested 4 days or more in the past week, by menopausal status.

United States, 2015image icon1Significant linear trend by menopausal status (p <. 0.05).NOTES. Women were postmenopausal if they had gone without a menstrual cycle for more than 1 year or were in surgical menopause after the removal of their ovaries. Women were perimenopausal if they no longer had a menstrual cycle and their last menstrual cycle was 1 year ago or less. Women were premenopausal if they still had a menstrual cycle.

Access data table for Figure 4pdf icon.SOURCE. NCHS, National Health Interview Survey, 2015. SummaryThis report describes sleep duration and sleep quality among U.S. Nonpregnant women aged 40–59 by menopausal status. Perimenopausal women were most likely to sleep less than 7 hours, on average, in a 24-hour period compared with premenopausal and postmenopausal women.

In contrast, postmenopausal women were most likely to have poor-quality sleep. A greater percentage of postmenopausal women had frequent trouble falling asleep, staying asleep, and not waking well rested compared with premenopausal women. The percentage of perimenopausal women with poor-quality sleep was between the percentages for the other two groups in all three categories. Sleep duration changes with advancing age (4), but sleep duration and quality are also influenced by concurrent changes in women’s reproductive hormone levels (5). Because sleep is critical for optimal health and well-being (6), the findings in this report highlight areas for further research and targeted health promotion.

DefinitionsMenopausal status. A three-level categorical variable was created from a series of questions that asked women. 1) “How old were you when your periods or menstrual cycles started?. €. 2) “Do you still have periods or menstrual cycles?.

€. 3) “When did you have your last period or menstrual cycle?. €. And 4) “Have you ever had both ovaries removed, either as part of a hysterectomy or as one or more separate surgeries?. € Women were postmenopausal if they a) had gone without a menstrual cycle for more than 1 year or b) were in surgical menopause after the removal of their ovaries.

Women were perimenopausal if they a) no longer had a menstrual cycle and b) their last menstrual cycle was 1 year ago or less. Premenopausal women still had a menstrual cycle.Not waking feeling well rested. Determined by respondents who answered 3 days or less on the questionnaire item asking, “In the past week, on how many days did you wake up feeling well rested?. €Short sleep duration. Determined by respondents who answered 6 hours or less on the questionnaire item asking, “On average, how many hours of sleep do you get in a 24-hour period?.

€Trouble falling asleep. Determined by respondents who answered four times or more on the questionnaire item asking, “In the past week, how many times did you have trouble falling asleep?. €Trouble staying asleep. Determined by respondents who answered four times or more on the questionnaire item asking, “In the past week, how many times did you have trouble staying asleep?. € Data source and methodsData from the 2015 National Health Interview Survey (NHIS) were used for this analysis.

NHIS is a multipurpose health survey conducted continuously throughout the year by the National Center for Health Statistics. Interviews are conducted in person in respondents’ homes, but follow-ups to complete interviews may be conducted over the telephone. Data for this analysis came from the Sample Adult core and cancer supplement sections of the 2015 NHIS. For more information about NHIS, including the questionnaire, visit the NHIS website.All analyses used weights to produce national estimates. Estimates on sleep duration and quality in this report are nationally representative of the civilian, noninstitutionalized nonpregnant female population aged 40–59 living in households across the United States.

The sample design is described in more detail elsewhere (7). Point estimates and their estimated variances were calculated using SUDAAN software (8) to account for the complex sample design of NHIS. Linear and quadratic trend tests of the estimated proportions across menopausal status were tested in SUDAAN via PROC DESCRIPT using the POLY option. Differences between percentages were evaluated using two-sided significance tests at the 0.05 level. About the authorAnjel Vahratian is with the National Center for Health Statistics, Division of Health Interview Statistics.

The author gratefully acknowledges the assistance of Lindsey Black in the preparation of this report. ReferencesFord ES. Habitual sleep duration and predicted 10-year cardiovascular risk using the pooled cohort risk equations among US adults. J Am Heart Assoc 3(6):e001454. 2014.Ford ES, Wheaton AG, Chapman DP, Li C, Perry GS, Croft JB.

Associations between self-reported sleep duration and sleeping disorder with concentrations of fasting and 2-h glucose, insulin, and glycosylated hemoglobin among adults without diagnosed diabetes. J Diabetes 6(4):338–50. 2014.American College of Obstetrics and Gynecology. ACOG Practice Bulletin No. 141.

Management of menopausal symptoms. Obstet Gynecol 123(1):202–16. 2014.Black LI, Nugent CN, Adams PF. Tables of adult health behaviors, sleep. National Health Interview Survey, 2011–2014pdf icon.

2016.Santoro N. Perimenopause. From research to practice. J Women’s Health (Larchmt) 25(4):332–9. 2016.Watson NF, Badr MS, Belenky G, Bliwise DL, Buxton OM, Buysse D, et al.

Recommended amount of sleep for a healthy adult. A joint consensus statement of the American Academy of Sleep Medicine and Sleep Research Society. J Clin Sleep Med 11(6):591–2. 2015.Parsons VL, Moriarity C, Jonas K, et al. Design and estimation for the National Health Interview Survey, 2006–2015.

National Center for Health Statistics. Vital Health Stat 2(165). 2014.RTI International. SUDAAN (Release 11.0.0) [computer software]. 2012.

Suggested citationVahratian A. Sleep duration and quality among women aged 40–59, by menopausal status. NCHS data brief, no 286. Hyattsville, MD. National Center for Health Statistics.

2017.Copyright informationAll material appearing in this report is in the public domain and may be reproduced or copied without permission. Citation as to source, however, is appreciated.National Center for Health StatisticsCharles J. Rothwell, M.S., M.B.A., DirectorJennifer H. Madans, Ph.D., Associate Director for ScienceDivision of Health Interview StatisticsMarcie L. Cynamon, DirectorStephen J.

Blumberg, Ph.D., Associate Director for Science.

NCHS Data Brief buy kamagra oral jelly wholesale No http://en.cubcadet.eu/symbicort-price-canada/. 286, September 2017PDF Versionpdf icon (374 KB)Anjel Vahratian, Ph.D.Key findingsData from the National Health Interview Survey, 2015Among those aged 40–59, perimenopausal women (56.0%) were more likely than postmenopausal (40.5%) and premenopausal (32.5%) women to sleep less than 7 hours, on average, in a 24-hour period.Postmenopausal women aged 40–59 were more likely than premenopausal women aged 40–59 to have trouble falling asleep (27.1% compared with 16.8%, respectively), and staying asleep (35.9% compared with 23.7%), four times or more in the past week.Postmenopausal women aged 40–59 (55.1%) were more likely than premenopausal women aged 40–59 (47.0%) to not wake up feeling well rested 4 days or more in the past week.Sleep duration and quality are important contributors to health and wellness. Insufficient sleep is associated with an increased risk for chronic conditions such as cardiovascular disease (1) and diabetes buy kamagra oral jelly wholesale (2). Women may be particularly vulnerable to sleep problems during times of reproductive hormonal change, such as after the menopausal transition. Menopause is “the permanent cessation of menstruation that occurs after the loss of ovarian buy kamagra oral jelly wholesale activity” (3).

This data brief describes sleep duration and sleep quality among nonpregnant women aged 40–59 by menopausal status. The age range selected for this analysis reflects the focus on midlife sleep health. In this analysis, 74.2% of women are buy kamagra oral jelly wholesale premenopausal, 3.7% are perimenopausal, and 22.1% are postmenopausal. Keywords. Insufficient sleep, menopause, National Health Interview Survey Perimenopausal women were buy kamagra oral jelly wholesale more likely than premenopausal and postmenopausal women to sleep less than 7 hours, on average, in a 24-hour period.More than one in three nonpregnant women aged 40–59 slept less than 7 hours, on average, in a 24-hour period (35.1%) (Figure 1).

Perimenopausal women were most likely to sleep less than 7 hours, on average, in a 24-hour period (56.0%), compared with 32.5% of premenopausal and 40.5% of postmenopausal women. Postmenopausal women were significantly more likely than premenopausal women to sleep less than 7 hours, on average, in a 24-hour period. Figure 1 buy kamagra oral jelly wholesale. Percentage of nonpregnant women aged 40–59 who slept less than 7 hours, on average, in a 24-hour period, by menopausal status. United States, 2015image icon1Significant quadratic trend by menopausal status (p buy kamagra oral jelly wholesale <.

0.05).NOTES. Women were postmenopausal if they had gone without a menstrual cycle for more than 1 year or were in surgical menopause after the removal of their ovaries. Women were perimenopausal buy kamagra oral jelly wholesale if they no longer had a menstrual cycle and their last menstrual cycle was 1 year ago or less. Women were premenopausal if they still had a menstrual cycle. Access data table for Figure 1pdf buy kamagra oral jelly wholesale icon.SOURCE.

NCHS, National Health Interview Survey, 2015. The percentage of women aged 40–59 who had trouble falling asleep four times or more in the past week varied by menopausal status.Nearly one in five nonpregnant women aged 40–59 had trouble falling asleep four times or more in the past week (19.4%) (Figure 2) buy kamagra oral jelly wholesale. The percentage of women in this age group who had trouble falling asleep four times or more in the past week increased from 16.8% among premenopausal women to 24.7% among perimenopausal and 27.1% among postmenopausal women. Postmenopausal women were significantly more likely than premenopausal women to have trouble falling asleep four times or more in the past week. Figure 2 buy kamagra oral jelly wholesale.

Percentage of nonpregnant women aged 40–59 who had trouble falling asleep four times or more in the past week, by menopausal status. United States, 2015image icon1Significant linear buy kamagra oral jelly wholesale trend by menopausal status (p <. 0.05).NOTES. Women were postmenopausal if they had gone without a menstrual cycle for more than 1 year or were in surgical menopause after the removal of their ovaries. Women were perimenopausal if they no longer had a menstrual cycle and their last menstrual cycle was 1 year ago or less buy kamagra oral jelly wholesale.

Women were premenopausal if they still had a menstrual cycle. Access data table buy kamagra oral jelly wholesale for Figure 2pdf icon.SOURCE. NCHS, National Health Interview Survey, 2015. The percentage of women aged 40–59 who had trouble staying asleep four times or more in the past week varied by menopausal status.More than one in four nonpregnant women aged 40–59 had trouble staying asleep buy kamagra oral jelly wholesale four times or more in the past week (26.7%) (Figure 3). The percentage of women aged 40–59 who had trouble staying asleep four times or more in the past week increased from 23.7% among premenopausal, to 30.8% among perimenopausal, and to 35.9% among postmenopausal women.

Postmenopausal women were significantly more likely than premenopausal women to have trouble staying asleep four times or more in the past week. Figure 3 buy kamagra oral jelly wholesale. Percentage of nonpregnant women aged 40–59 who had trouble staying asleep four times or more in the past week, by menopausal status. United States, 2015image icon1Significant linear trend by menopausal status buy kamagra oral jelly wholesale (p <. 0.05).NOTES.

Women were postmenopausal if they had gone without a menstrual cycle for more than 1 year or were in surgical menopause after the removal of their ovaries. Women were perimenopausal if they no longer buy kamagra oral jelly wholesale had a menstrual cycle and their last menstrual cycle was 1 year ago or less. Women were premenopausal if they still had a menstrual cycle. Access data table for Figure buy kamagra oral jelly wholesale 3pdf icon.SOURCE. NCHS, National Health Interview Survey, 2015.

The percentage of women aged 40–59 who did not wake up feeling well rested 4 days or more in the past week varied by menopausal status.Nearly one in two nonpregnant women aged 40–59 did not wake up feeling well rested 4 days or more in the past week (48.9%) (Figure 4). The percentage of women in this age group who did not wake up feeling well rested 4 days or more in buy kamagra oral jelly wholesale the past week increased from 47.0% among premenopausal women to 49.9% among perimenopausal and 55.1% among postmenopausal women. Postmenopausal women were significantly more likely than premenopausal women to not wake up feeling well rested 4 days or more in the past week. Figure 4 buy kamagra oral jelly wholesale. Percentage of nonpregnant women aged 40–59 who did not wake up feeling well rested 4 days or more in the past week, by menopausal status.

United States, 2015image icon1Significant linear trend by menopausal status (p <. 0.05).NOTES. Women were postmenopausal if they had gone without a menstrual cycle for more than 1 year or were in surgical menopause after the removal of their ovaries. Women were perimenopausal if they no longer had a menstrual cycle and their last menstrual cycle was 1 year ago or less. Women were premenopausal if they still had a menstrual cycle.

Access data table for Figure 4pdf icon.SOURCE. NCHS, National Health Interview Survey, 2015. SummaryThis report describes sleep duration and sleep quality among U.S. Nonpregnant women aged 40–59 by menopausal status. Perimenopausal women were most likely to sleep less than 7 hours, on average, in a 24-hour period compared with premenopausal and postmenopausal women.

In contrast, postmenopausal women were most likely to have poor-quality sleep. A greater percentage of postmenopausal women had frequent trouble falling asleep, staying asleep, and not waking well rested compared with premenopausal women. The percentage of perimenopausal women with poor-quality sleep was between the percentages for the other two groups in all three categories. Sleep duration changes with advancing age (4), but sleep duration and quality are also influenced by concurrent changes in women’s reproductive hormone levels (5). Because sleep is critical for optimal health and well-being (6), the findings in this report highlight areas for further research and targeted health promotion.

DefinitionsMenopausal status. A three-level categorical variable was created from a series of questions that asked women. 1) “How old were you when your periods or menstrual cycles started?. €. 2) “Do you still have periods or menstrual cycles?.

€. 3) “When did you have your last period or menstrual cycle?. €. And 4) “Have you ever had both ovaries removed, either as part of a hysterectomy or as one or more separate surgeries?. € Women were postmenopausal if they a) had gone without a menstrual cycle for more than 1 year or b) were in surgical menopause after the removal of their ovaries.

Women were perimenopausal if they a) no longer had a menstrual cycle and b) their last menstrual cycle was 1 year ago or less. Premenopausal women still had a menstrual cycle.Not waking feeling well rested. Determined by respondents who answered 3 days or less on the questionnaire item asking, “In the past week, on how many days did you wake up feeling well rested?. €Short sleep duration. Determined by respondents who answered 6 hours or less on the questionnaire item asking, “On average, how many hours of sleep do you get in a 24-hour period?.

€Trouble falling asleep. Determined by respondents who answered four times or more on the questionnaire item asking, “In the past week, how many times did you have trouble falling asleep?. €Trouble staying asleep. Determined by respondents who answered four times or more on the questionnaire item asking, “In the past week, how many times did you have trouble staying asleep?. € Data source and methodsData from the 2015 National Health Interview Survey (NHIS) were used for this analysis.

NHIS is a multipurpose health survey conducted continuously throughout the year by the National Center for Health Statistics. Interviews are conducted in person in respondents’ homes, but follow-ups to complete interviews may be conducted over the telephone. Data for this analysis came from the Sample Adult core and cancer supplement sections of the 2015 NHIS. For more information about NHIS, including the questionnaire, visit the NHIS website.All analyses used weights to produce national estimates. Estimates on sleep duration and quality in this report are nationally representative of the civilian, noninstitutionalized nonpregnant female population aged 40–59 living in households across the United States.

The sample design is described in more detail elsewhere (7). Point estimates and their estimated variances were calculated using SUDAAN software (8) to account for the complex sample design of NHIS. Linear and quadratic trend tests of the estimated proportions across menopausal status were tested in SUDAAN via PROC DESCRIPT using the POLY option. Differences between percentages were evaluated using two-sided significance tests at the 0.05 level. About the authorAnjel Vahratian is with the National Center for Health Statistics, Division of Health Interview Statistics.

The author gratefully acknowledges the assistance of Lindsey Black in the preparation of this report. ReferencesFord ES. Habitual sleep duration and predicted 10-year cardiovascular risk using the pooled cohort risk equations among US adults. J Am Heart Assoc 3(6):e001454. 2014.Ford ES, Wheaton AG, Chapman DP, Li C, Perry GS, Croft JB.

Associations between self-reported sleep duration and sleeping disorder with concentrations of fasting and 2-h glucose, insulin, and glycosylated hemoglobin among adults without diagnosed diabetes. J Diabetes 6(4):338–50. 2014.American College of Obstetrics and Gynecology. ACOG Practice Bulletin No. 141.

Management of menopausal symptoms. Obstet Gynecol 123(1):202–16. 2014.Black LI, Nugent CN, Adams PF. Tables of adult health behaviors, sleep. National Health Interview Survey, 2011–2014pdf icon.

2016.Santoro N. Perimenopause. From research to practice. J Women’s Health (Larchmt) 25(4):332–9. 2016.Watson NF, Badr MS, Belenky G, Bliwise DL, Buxton OM, Buysse D, et al.

Recommended amount of sleep for a healthy adult. A joint consensus statement of the American Academy of Sleep Medicine and Sleep Research Society. J Clin Sleep Med 11(6):591–2. 2015.Parsons VL, Moriarity C, Jonas K, et al. Design and estimation for the National Health Interview Survey, 2006–2015.

National Center for Health Statistics. Vital Health Stat 2(165). 2014.RTI International. SUDAAN (Release 11.0.0) [computer software]. 2012.

Suggested citationVahratian A. Sleep duration and quality among women aged 40–59, by menopausal status. NCHS data brief, no 286. Hyattsville, MD. National Center for Health Statistics.

2017.Copyright informationAll material appearing in this report is in the public domain and may be reproduced or copied without permission. Citation as to source, however, is appreciated.National Center for Health StatisticsCharles J. Rothwell, M.S., M.B.A., DirectorJennifer H. Madans, Ph.D., Associate Director for ScienceDivision of Health Interview StatisticsMarcie L. Cynamon, DirectorStephen J.

Blumberg, Ph.D., Associate Director for Science.

Kamagra polo chewable tablets

W-sitting is a normal developmental position that babies usually https://www.gastern.at/2020/01/10/das-war-der-neujahrsempfang-2020/ discover when they sit back straight kamagra polo chewable tablets from their hands and knees. Their legs will then form a “W.” Often, babies also transition back to a single hip, toward a side sitting position. When a baby varies his kamagra polo chewable tablets or her sitting position, W-sitting is rarely a problem. However, when a baby sits back straight to a W-sit consistently, they don’t get the opportunity to elongate and activate lateral trunk muscles to develop their core muscles. W-sitting is a very stable position kamagra polo chewable tablets that children find useful, however, it allows them to play without developing muscle that provide the ability for kids to reach out to their sides or rotate across their midline, leading to underdevelopment of lower trunk muscles, which stabilize the pelvis.

When a child uses this position as their preference without the normal variety in movements, it can affect development. They may kamagra polo chewable tablets demonstrate an in-toeing gait, core weakness or balance difficulties. The hips are positioned in extreme internal rotation, placing stress on the hips and the knee joints. This can lead to hip and knee orthopedic issues as the child develops. So, what kamagra polo chewable tablets can you do to prevent any development issues?.

Encourage your child to alternate sitting positions, such as side sitting (alternating sides), ring sitting, or, with older children, sitting in a chair or on a ball. This might be challenging initially, but once your kamagra polo chewable tablets child gets used to it, they may just need reminders. If it’s difficult for your child to sit in alternate positions or they begin to show other developmental concerns, a referral to a physical therapist may be helpful to facilitate trunk muscle development. Eileen McMahon, M.S.P.T., is a physical therapist at MidMichigan Health.Many athletes have had their baseball season shortened kamagra polo chewable tablets or cancelled due to erectile dysfunction treatment. This extra rest can be helpful in decreasing stress on the shoulder and elbow joints, but it can also lead to decreased strength and ROM.

Overhead athletes need to keep their bodies strong, and a great way to achieve that is by performing a kamagra polo chewable tablets regular strengthening program. With many gyms remaining closed or limiting access during social distancing, that can be even more challenging. However, there are many exercises that can be done at home with minimal equipment needs. A great program to focus on during the off season is the Thrower’s Ten kamagra polo chewable tablets program that was developed with the overhead athlete in mind. These exercises focus on the muscle groups that matter most for the overhead athlete.

We use our entire body to throw a ball and the kamagra polo chewable tablets stress on the shoulder to decelerate the arm is about twice our body weight. Most of this stress gets placed on the rotator cuff and scapular muscles that slow the arm down as we follow through with our throw. Weakness in these muscles can lead to problems with kamagra polo chewable tablets the shoulder and elbow joints. Common injuries can be Little League shoulder and elbow or strains to the ulnar collateral ligaments (Tommy John). If you have dealt with pain or injuries kamagra polo chewable tablets in the past, a comprehensive evaluation by a physical therapist (PT) who focuses on treating the overhead athlete can be extremely helpful in identifying areas of concern.

Your PT will evaluate your strength with a dynamometer to look at any significant abnormalities between shoulders. They can also perform a video throwing analysis to look at ways to potentially reduce injury risk and improve performance. This can almost always be achieved with only a couple of visits, and the off season is a great time to start addressing areas of concern to be ready for next season or throwing kamagra polo chewable tablets during the winter. Your PT can help you develop a customized home exercise program based on your needs. Physical kamagra polo chewable tablets Therapist Kyle Stevenson, D.P.T., sees patients at MidMichigan’s Rehabilitation Services location in Greater Midland North-End Fitness Center.

He has a special interest in sports medicine, and enjoys working with athletes of all ages. He has completed specialized coursework and kamagra polo chewable tablets training for the throwing athletes. New patients are welcome with a physician referral by calling (989) 832-5913. Those who would like more information about MidMichigan’s Rehabilitation Services may visit www.midmichigan.org/rehabilitation..

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However, when a baby sits back straight to a W-sit consistently, they don’t get the opportunity to elongate and activate lateral trunk muscles to develop their core muscles. W-sitting is a very stable position that children find useful, however, it allows them to play without developing muscle that provide the ability for kids to buy kamagra oral jelly wholesale reach out to their sides or rotate across their midline, leading to underdevelopment of lower trunk muscles, which stabilize the pelvis. When a child uses this position as their preference without the normal variety in movements, it can affect development.

They may demonstrate an in-toeing gait, core weakness or balance difficulties buy kamagra oral jelly wholesale. The hips are positioned in extreme internal rotation, placing stress on the hips and the knee joints. This can lead to hip and knee orthopedic issues as the child develops.

So, what can buy kamagra oral jelly wholesale you do to prevent any development issues?. Encourage your child to alternate sitting positions, such as side sitting (alternating sides), ring sitting, or, with older children, sitting in a chair or on a ball. This might be challenging initially, but once your child gets used to buy kamagra oral jelly wholesale it, they may just need reminders.

If it’s difficult for your child to sit in alternate positions or they begin to show other developmental concerns, a referral to a physical therapist may be helpful to facilitate trunk muscle development. Eileen McMahon, M.S.P.T., is a physical therapist at MidMichigan Health.Many athletes have had their baseball buy kamagra oral jelly wholesale season shortened or cancelled due to erectile dysfunction treatment. This extra rest can be helpful in decreasing stress on the shoulder and elbow joints, but it can also lead to decreased strength and ROM.

Overhead athletes need to keep buy kamagra oral jelly wholesale their bodies strong, and a great way to achieve that is by performing a regular strengthening program. With many gyms remaining closed or limiting access during social distancing, that can be even more challenging. However, there are many exercises that can be done at home with read the full info here minimal equipment needs.

A great program to focus on during the off season is the Thrower’s Ten buy kamagra oral jelly wholesale program that was developed with the overhead athlete in mind. These exercises focus on the muscle groups that matter most for the overhead athlete. We use our entire body to throw a ball and buy kamagra oral jelly wholesale the stress on the shoulder to decelerate the arm is about twice our body weight.

Most of this stress gets placed on the rotator cuff and scapular muscles that slow the arm down as we follow through with our throw. Weakness in these muscles buy kamagra oral jelly wholesale can lead to problems with the shoulder and elbow joints. Common injuries can be Little League shoulder and elbow or strains to the ulnar collateral ligaments (Tommy John).

If you have dealt with pain or injuries in the past, a comprehensive evaluation by a physical therapist (PT) who focuses on treating the overhead athlete can buy kamagra oral jelly wholesale be extremely helpful in identifying areas of concern. Your PT will evaluate your strength with a dynamometer to look at any significant abnormalities between shoulders. They can also perform a video throwing analysis to look at ways to potentially reduce injury risk and improve performance.

This can almost always be achieved with only a couple of visits, and buy kamagra oral jelly wholesale the off season is a great time to start addressing areas of concern to be ready for next season or throwing during the winter. Your PT can help you develop a customized home exercise program based on your needs. Physical Therapist Kyle Stevenson, D.P.T., sees patients at MidMichigan’s Rehabilitation Services location in Greater buy kamagra oral jelly wholesale Midland North-End Fitness Center.

He has a special interest in sports medicine, and enjoys working with athletes of all ages. He has completed specialized coursework and training for the throwing athletes. New patients are welcome with a physician referral by calling (989) 832-5913.

Those who would like more information about MidMichigan’s Rehabilitation Services may visit www.midmichigan.org/rehabilitation..

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Nightmares that occurred twice a week or more were linked with cardiovascular disease in relatively young military veterans, even after controlling for post-traumatic stress disorder (PTSD), a cross-sectional study showed.Frequent distressing dreams were associated with hypertension (OR 1.51, 95% CI 1.28-1.78), heart problems (OR 1.50, 95% CI 1.11-2.02), and myocardial infarction (OR 2.32, 95% CI 1.18-4.54), after adjusting for age, race, and sex, reported Christi Ulmer, PhD, of the Durham VA Health Services Research and Development ADAPT Center and Duke University Medical Center, both in North Carolina."After also adjusting for PTSD, depression, and current smoking, severely distressing dreams continued to be associated with heart problems, hypertension, and other heart trouble," Ulmer said in a presentation at virtual SLEEP 2020, a joint meeting of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society."Research on heart rate variability supports the likelihood of difference between kamagra and kamagra gold abnormal autonomic function during sleep among those with PTSD. However, we haven't taken a look at what role nightmares specifically might play in contributing to increased risk in this population," Ulmer noted."While some have suggested that the association between PTSD and cardiovascular disease is solely due to poor health behaviors among those with PTSD, difference between kamagra and kamagra gold our findings suggest an important role for sleep and that there may be an independent role for nightmares, in particular for conferring cardiovascular disease," she said.In this analysis, Ulmer and colleagues studied 3,468 U.S. Military veterans with difference between kamagra and kamagra gold an average age of 38 who served since Sept. 11, 2001 difference between kamagra and kamagra gold. The majority (73.5%) had one difference between kamagra and kamagra gold or two tours of duty and most (77.4%) were men.

Most (65.0%) had moderate-to-heavy combat exposure.The researchers assessed difference between kamagra and kamagra gold nightmare frequency and severity with the Davidson Trauma Scale. Nightmares were classified as frequent if they occurred two or more times per week and difference between kamagra and kamagra gold moderate-to-severe if they were at least moderately distressing. Self-reported medical issues were assessed using the National Vietnam Veterans Readjustment difference between kamagra and kamagra gold Study questionnaire and other measures. Diagnoses of PTSD and depression were established through structured clinical interviews.About a third of veterans in the study reported nightmares in the past week, difference between kamagra and kamagra gold and 41% had poor sleep quality scores as measured by the Pittsburgh Sleep Quality Index. In total, 31% difference between kamagra and kamagra gold of the veterans met criteria for current PTSD and 32.7% reported at least one cardiovascular condition.Diagnosed depression was more common in the PTSD group.

Veterans with PTSD served more tours of duty, had greater combat exposure, poorer sleep quality, and more frequent and more severe distressing dreams.After controlling difference between kamagra and kamagra gold for depression, PTSD, and current smoking, risks for hypertension (OR 1.43, 95% 1.17-1.73) and heart problems (OR 1.43, 95% CI 1.00-2.05) persisted among veterans with frequent nightmares.The findings set the stage for future research examining the possibility that nightmares may confer cardiovascular disease risks beyond those conferred by PTSD diagnosis alone, Ulmer noted."If longitudinal research demonstrates a causal role for nightmares in cardiovascular disease risk, nightmare treatment could be a strategy for improving cardiovascular health," she said. Judy George covers neurology and neuroscience news for MedPage Today, writing about brain aging, Alzheimer’s, dementia, MS, rare difference between kamagra and kamagra gold diseases, epilepsy, autism, headache, stroke, Parkinson’s, ALS, concussion, CTE, sleep, pain, and more. Follow Disclosures The study was supported by the Department of Veterans VISN 6 MIRECC and ADAPT Centers at the Durham VA Health Care System.In chronic kidney disease (CKD), dapagliflozin (Farxiga) reduced renal events and substantially improved overall survival, regardless of diabetes status, the DAPA-CKD trial showed.The SGLT2 drug reduced by a relative 39% the primary endpoint of worsening kidney function (more than 50% sustained decline in estimated glomerular filtration rate [eGFR] or onset of end-stage kidney disease) or death due to kidney disease or cardiovascular disease (312 vs 197 events at a median 2.4 years, HR 0.61, 95% CI 0.51-0.72).The number needed to treat to prevent one such event was just 19, reported Hiddo Heerspink, PharmD, PhD, of the University Medical Center Groningen, the Netherlands, at the European Society of Cardiology virtual meeting.The effect was significant for those with type 2 diabetes and without it (HR 0.64 and 0.50, P=0.24 for interaction).Most notable among the secondary endpoints was the 31% relative reduction in all-cause mortality (P=0.0035, with 101 vs 146 events with placebo).Clinical Implications"For difference between kamagra and kamagra gold nephrologists who are struggling with the epidemic of kidney disease and the few options available to treat its progression effectively, the possibility of this new effective treatment is cause to celebrate," commented Ladan Golestaneh MD, a nephrologist at Montefiore Medical Center in New York City, predicting changes to the CKD care guidelines.Until recently, ACE inhibitors and angiotensin receptor blockers (ARBs) were the only medications specifically proven to slow CKD progression, Heerspink noted at the ESC hot-line session.But the effect size with dapagliflozin was higher than seen with the ACE/ARB drugs versus placebo in patients with and without type 2 diabetes for composite CKD events, noted Holly Kramer, MD, president of the National Kidney Foundation.It was larger than the relative effects of lower blood pressure targets on composite CKD outcomes in adults with and without type 2 diabetes, she pointed out. The trial "greatly increases the impact these drugs will have on reducing end-stage renal disease," she told MedPage Today.Golestaneh noted that SGLT2 inhibitors have already been increasingly used in nephrologist clinic practice as a means to decrease the progression of diabetic nephropathy and predicted that the demonstration of efficacy in non-diabetic kidney disease would drive that higher.For cardiologists, too, "it's really exciting," even if not surprising, commented Milton Packer, MD, of the Baylor Heart and Vascular Institute in Dallas, who presented at the conference positive findings in heart failure with reduced ejection fraction with fellow SGLT2 inhibitor empagliflozin (Jardiance), including benefits for renal endpoints."We know that SGLT2 inhibitors protect the heart and the kidney," he difference between kamagra and kamagra gold said. "In many ways, chronic kidney difference between kamagra and kamagra gold disease trials are in parallel to chronic heart failure trials, because SGLT2 inhibitors benefit both organs."ESC session moderator Frank Ruschitzka, MD, of the Heart Center at University Hospital Zurich, agreed, calling DAPA-CKD fantastic."We are thinking as cardiologists probably too much into boxes, compartmentalization," he said.

"Maybe we need a difference between kamagra and kamagra gold more holistic view... They're certainly not just difference between kamagra and kamagra gold glucose-lowering drugs. They're not just only difference between kamagra and kamagra gold diuretics. Maybe we should just move to organ protection."Trial DetailsThe trial included 4,304 adults with CKD (eGFR 25 to 75 mL/min/1.73 m2 and urine albumin to creatinine ratio of 200 to 5,000 mg/g), about 67% of whom had type 2 diabetes, and all on a maximally-tolerated dose of difference between kamagra and kamagra gold an ACE inhibitor or ARB. They were randomized to 10 mg dapagliflozin difference between kamagra and kamagra gold once daily or matching placebo.

People with type 1 diabetes were excluded.The trial was stopped early for efficacy after a median follow-up of 2.4 years with 60% difference between kamagra and kamagra gold of the planned events.Dapagliflozin also significantly improved each component of the primary composite (with the exception of a nonsignificant trend for cardiovascular death) as well as secondary composite outcomes:44% lower risk of worsening renal function or renal death34% lower risk of chronic dialysis, kidney transplantation, or renal death29% lower risk of CV death or heart failure hospitalizationNo cases of diabetic ketoacidosis occurred in the dapagliflozin group. Serious adverse events were actually numerically less common with the drug, which Heerspink said was in keeping with difference between kamagra and kamagra gold dapagliflozin's established safety profile.The Future for SGLT2 InhibitorsPacker noted that a similar CKD trial is underway with empagliflozin (EMPA-KIDNEY, with data expected in 2022) in a population with and without diabetes. The drug difference between kamagra and kamagra gold has FDA fast track designation for an indication in that regard. The CREDENCE trial previously showed that SGLT2 inhibitor canagliflozin (Invokana) improved outcomes in CKD patients with type 2 diabetes."The thing really amazing about SGLT2 inhibitors is that it's not like our evidence is difference between kamagra and kamagra gold one or two trials -- it's going to be like nine or 10 large scale trials, which is extraordinary," Packer said. "For most classes of drugs, we don't have that kind of evidence difference between kamagra and kamagra gold base.

... Physicians have to start using SGLT2 inhibitors across the board for these patients. It's not only the consistency of these results, it's the magnitude."And with multiple agents in the class proving their chops for organ protection, "it's going to be very hard for insurers to say no to drugs like this," commented Dipti Itchhaporia, MD, vice president of the American College of Cardiology. "The more data, the easier it is for us to get these covered.""Patients balk at the idea of all these additional drugs and the cost of all these drugs," she acknowledged, noting that SGLT2 inhibitors are looking to be the fourth cornerstone of heart failure therapy. "But if you make the case, and you explain to them why they need to take these drugs, they usually are amenable.

When you say you're going to live longer, feel better, you're not going to come into the hospital as much, it's hard to argue against that." Disclosures Heerspink disclosed relevant relationships with AbbVie, AstraZeneca, Bayer, Boehringer Ingelheim, Chinook, CSL Pharma, Gilead, Janssen, Merck, Mundipharma, Mitsubishi Tanabe, Novo Nordisk, and Retrophin.Golestaneh disclosed relevant relationships with Horizon Pharmaceuticals and being a member of the clinical events committee for trials sponsored by Medtronic..

Nightmares that occurred twice a week or more were linked with cardiovascular disease in relatively young military veterans, even after controlling for post-traumatic stress disorder (PTSD), a cross-sectional study showed.Frequent distressing dreams were associated with hypertension (OR 1.51, 95% CI 1.28-1.78), heart problems (OR 1.50, 95% CI 1.11-2.02), and myocardial infarction (OR 2.32, 95% CI 1.18-4.54), after adjusting for age, race, and sex, reported Christi Ulmer, PhD, of the Durham VA Health Services Research and Development ADAPT Center and Duke University Medical Center, buy kamagra oral jelly wholesale both in North Carolina."After also adjusting for PTSD, depression, and current smoking, severely distressing dreams continued to be associated with heart problems, hypertension, and other heart trouble," Ulmer said in a presentation at virtual SLEEP 2020, a joint meeting of the American Academy https://www.hommage-leipzig.de/seminare/offene-seminare/der-schluessel-zum-mitmenschen/ of Sleep Medicine (AASM) and the Sleep Research Society."Research on heart rate variability supports the likelihood of abnormal autonomic function during sleep among those with PTSD. However, we haven't taken a look at what role nightmares specifically might play in contributing to increased risk in this population," Ulmer noted."While some have suggested that the association between PTSD and cardiovascular disease is solely due to poor health behaviors among those with PTSD, our findings suggest an important role for sleep and that there may be an independent role for nightmares, in particular for buy kamagra oral jelly wholesale conferring cardiovascular disease," she said.In this analysis, Ulmer and colleagues studied 3,468 U.S. Military veterans with an buy kamagra oral jelly wholesale average age of 38 who served since Sept.

11, 2001 buy kamagra oral jelly wholesale. The majority (73.5%) had one buy kamagra oral jelly wholesale or two tours of duty and most (77.4%) were men. Most (65.0%) had moderate-to-heavy combat exposure.The researchers assessed nightmare frequency and severity with the buy kamagra oral jelly wholesale Davidson Trauma Scale.

Nightmares were classified as frequent if they occurred two or more times per week and moderate-to-severe if they buy kamagra oral jelly wholesale were at least moderately distressing. Self-reported medical buy kamagra oral jelly wholesale issues were assessed using the National Vietnam Veterans Readjustment Study questionnaire and other measures. Diagnoses of buy kamagra oral jelly wholesale PTSD and depression were established through structured clinical interviews.About a third of veterans in the study reported nightmares in the past week, and 41% had poor sleep quality scores as measured by the Pittsburgh Sleep Quality Index.

In total, 31% of buy kamagra oral jelly wholesale the veterans met criteria for current PTSD and 32.7% reported at least one cardiovascular condition.Diagnosed depression was more common in the PTSD group. Veterans with PTSD served more tours of duty, had greater combat exposure, poorer sleep quality, and more frequent and more severe distressing dreams.After controlling for depression, PTSD, and current smoking, risks for hypertension (OR 1.43, 95% 1.17-1.73) and heart problems (OR 1.43, 95% CI 1.00-2.05) persisted among veterans with frequent nightmares.The findings set the stage for future research examining the possibility that nightmares may confer cardiovascular disease risks beyond those buy kamagra oral jelly wholesale conferred by PTSD diagnosis alone, Ulmer noted."If longitudinal research demonstrates a causal role for nightmares in cardiovascular disease risk, nightmare treatment could be a strategy for improving cardiovascular health," she said. Judy George covers neurology and neuroscience news for MedPage Today, writing about brain aging, Alzheimer’s, dementia, MS, rare diseases, epilepsy, autism, headache, stroke, Parkinson’s, ALS, buy kamagra oral jelly wholesale concussion, CTE, sleep, pain, and more.

Follow Disclosures The study was supported by the Department of Veterans VISN 6 MIRECC and ADAPT Centers at the Durham VA Health Care System.In chronic kidney disease (CKD), dapagliflozin (Farxiga) reduced renal events and substantially improved overall survival, regardless of diabetes status, the DAPA-CKD trial showed.The SGLT2 drug reduced by a relative 39% the primary endpoint of worsening kidney function (more than 50% sustained decline in estimated glomerular filtration rate [eGFR] or onset of end-stage kidney disease) or death due to kidney disease or cardiovascular disease (312 vs 197 events at a median 2.4 years, HR 0.61, 95% CI 0.51-0.72).The number needed to treat to prevent one such event was just 19, reported Hiddo Heerspink, PharmD, PhD, of the University Medical Center Groningen, the Netherlands, at the European Society of Cardiology virtual meeting.The effect was significant for those with type 2 diabetes and without it (HR 0.64 and 0.50, P=0.24 for interaction).Most notable among the secondary endpoints was the 31% relative reduction in all-cause mortality (P=0.0035, with 101 vs 146 events with placebo).Clinical Implications"For nephrologists who are struggling with the epidemic of kidney disease and the few options available to treat its progression effectively, the possibility of this new effective treatment is cause to celebrate," commented Ladan Golestaneh MD, a nephrologist at Montefiore Medical Center in New York City, predicting changes to the CKD care guidelines.Until recently, ACE inhibitors and angiotensin receptor blockers (ARBs) were the only medications specifically proven to slow CKD progression, Heerspink noted at the ESC hot-line session.But the effect size with dapagliflozin was higher than seen with the ACE/ARB drugs versus placebo in patients with and without type 2 diabetes for composite CKD events, noted Holly Kramer, MD, president of the National Kidney Foundation.It was larger than the relative effects of lower blood pressure targets on composite CKD outcomes buy kamagra oral jelly wholesale in adults with and without type 2 diabetes, she pointed out. The trial "greatly increases the impact these drugs will have on reducing end-stage renal disease," she told MedPage Today.Golestaneh noted that SGLT2 inhibitors have buy kamagra oral jelly wholesale already been increasingly used in nephrologist clinic practice as a means to decrease the progression of diabetic nephropathy and predicted that the demonstration of efficacy in non-diabetic kidney disease would drive that higher.For cardiologists, too, "it's really exciting," even if not surprising, commented Milton Packer, MD, of the Baylor Heart and Vascular Institute in Dallas, who presented at the conference positive findings in heart failure with reduced ejection fraction with fellow SGLT2 inhibitor empagliflozin (Jardiance), including benefits for renal endpoints."We know that SGLT2 inhibitors protect the heart and the kidney," he said. "In many ways, chronic kidney disease trials are in parallel to chronic buy kamagra oral jelly wholesale heart failure trials, because SGLT2 inhibitors benefit both organs."ESC session moderator Frank Ruschitzka, MD, of the Heart Center at University Hospital Zurich, agreed, calling DAPA-CKD fantastic."We are thinking as cardiologists probably too much into boxes, compartmentalization," he said.

"Maybe we need a more buy kamagra oral jelly wholesale holistic view... They're certainly not just buy kamagra oral jelly wholesale glucose-lowering drugs. They're not buy kamagra oral jelly wholesale just only diuretics.

Maybe we should just move to organ protection."Trial DetailsThe trial included 4,304 adults with CKD (eGFR 25 to 75 mL/min/1.73 m2 and urine albumin to creatinine ratio of 200 to 5,000 mg/g), about 67% of whom had type 2 diabetes, and all on buy kamagra oral jelly wholesale a maximally-tolerated dose of an ACE inhibitor or ARB. They were buy kamagra oral jelly wholesale randomized to 10 mg dapagliflozin once daily or matching placebo. People with type 1 diabetes were excluded.The trial was stopped early for buy kamagra oral jelly wholesale efficacy after a median follow-up of 2.4 years with 60% of the planned events.Dapagliflozin also significantly improved each component of the primary composite (with the exception of a nonsignificant trend for cardiovascular death) as well as secondary composite outcomes:44% lower risk of worsening renal function or renal death34% lower risk of chronic dialysis, kidney transplantation, or renal death29% lower risk of CV death or heart failure hospitalizationNo cases of diabetic ketoacidosis occurred in the dapagliflozin group.

Serious adverse events were actually numerically less common with the drug, which Heerspink said was in keeping with dapagliflozin's established safety profile.The Future for SGLT2 InhibitorsPacker buy kamagra oral jelly wholesale noted that a similar CKD trial is underway with empagliflozin (EMPA-KIDNEY, with data expected in 2022) in a population with and without diabetes. The drug has FDA fast track designation for an indication in that regard buy kamagra oral jelly wholesale. The CREDENCE trial previously showed that SGLT2 inhibitor canagliflozin (Invokana) improved outcomes in CKD patients with type 2 diabetes."The thing really amazing about SGLT2 inhibitors is that it's not like our evidence is one or two trials -- it's going to be like nine or 10 large scale buy kamagra oral jelly wholesale trials, which is extraordinary," Packer said.

"For most classes of drugs, we don't have that kind buy kamagra oral jelly wholesale of evidence base. ... Physicians have to start using SGLT2 inhibitors across the board for these patients.

It's not only the consistency of these results, it's the magnitude."And with multiple agents in the class proving their chops for organ protection, "it's going to be very hard for insurers to say no to drugs like this," commented Dipti Itchhaporia, MD, vice president of the American College of Cardiology. "The more data, the easier it is for us to get these covered.""Patients balk at the idea of all these additional drugs and the cost of all these drugs," she acknowledged, noting that SGLT2 inhibitors are looking to be the fourth cornerstone of heart failure therapy. "But if you make the case, and you explain to them why they need to take these drugs, they usually are amenable.

When you say you're going to live longer, feel better, you're not going to come into the hospital as much, it's hard to argue against that." Disclosures Heerspink disclosed relevant relationships with AbbVie, AstraZeneca, Bayer, Boehringer Ingelheim, Chinook, CSL Pharma, Gilead, Janssen, Merck, Mundipharma, Mitsubishi Tanabe, Novo Nordisk, and Retrophin.Golestaneh disclosed relevant relationships with Horizon Pharmaceuticals and being a member of the clinical events committee for trials sponsored by Medtronic..

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Here is our next installment of a new buy kamagra oral jelly wholesale pop-up podcast miniseries that takes your ears into the deep sound of nature. Host Jacob Job, an ecologist and audiophile, brings you inches away from a multitude of creatures, great and small, amid the sonic grandeur of nature. You may not be easily able buy kamagra oral jelly wholesale to access these places amid the kamagra, but after you take this acoustic journey, you will be longing to get back outside.Strap on some headphones, find a quiet place, and prepare to experience sunrise on a Yellowstone marsh and then relax—if you can—close enough to a bison to hear it eat its lunch. You can catch more episodes in the series here..