Traduction de «Lariam » (Anglais → Français) :

Lariam Safety Monitoring Study [ Lariam (Mefloquine) Safety Monitoring Program ]

Lariam | mefloquine | mefloquine hydrochloride

...ces participating in the Lariam (mefloquine) Safety Monitoring Study during this period; (c) was the mefloquine administered in accordance with the Lariam Safety Monitoring Study and the Food and Drug Act; (d) who was the “principal investigator” responsible for the Lariam Safety Monitoring Study in the Canadian Forces; (e) who was the Canadian Forces physician responsible to the “principal investigator” of the Lariam Safety Monitoring Study; (f) what was the role of Canadian Forces physician, Dr. Martin Tepper, in the Lariam Safety Monitoring Study; (g) who was responsible for the Lariam Safety Monitoring Study at the Department ...[+++] of Health's Health Protection Branch during this period; (h) what was the role and responsibility of the Health Protection Branch under the Lariam Safety Monitoring Study and the Food and Drug Act and its regulations in regard to the use of mefloquine by Canadian Forces personnel; (i) when did the Health Protection Branch become aware that mefloquine was being administered to Canadian Forces personnel bound for Somalia; (j) what responsibility did the Canadian Forces have under the Lariam Safety Monitoring Study and the Food and Drug Act prior to the licensing of mefloquine to inform the manufacturer of its use; (k) what responsibility did the Canadian Forces have under the Lariam Safety Monitoring Study and the Food and Drug Act to the soldiers who were administered the drug; (l) did the Canadian Forces fulfil their responsibility to the manufacturer under the Lariam Safety Monitoring Study and the Food and Drug Act prior to the licensing of mefloquine and if so how did they do so; (m) what responsibility prior to the licensing of mefloquine did the Canadian Forces have under the Lariam Safety Monitoring Study and the Food and Drug Act to the Health Protection Branch; (n) did the Canadian Forces fulfil their pre-licensing responsibilities to the Health Protection Branch under the Lariam Safety Monitoring Study and the Food and Drug Act and if so how did they comply; (o) what action did the Health Protection Branch take in regard to the manufacturer on becoming aware that mefloquine had been administered to Canadian Forces in association with subsequent unexpected bizarre homicidal/suicidal behaviour; (p) what action did the Health Protection take in regard to the Canadian Force ...

...sure compliance with the Lariam safety monitoring study and the failure of the Department of National Defence to comply with its obligations under the safety monitoring study; (d) with regard to the mefloquine (Lariam) used for the prophylaxis of Canadian troops deployed to Somalia, what was the outcome of the Department of Health's Health Protection Branch investigations in October 1997 into the failure of the manufacturer to properly supervise and ensure compliance with the Lariam safety monitoring study and the failure of the D ...[+++]epartment of National Defence to comply with its obligations under the safety monitoring study; (e) what is the date of the insert in the mefloquine (Lariam) package used in Canada today; (f) what is the date of the product monograph for mefloquine (Lariam) used in Canada today; (g) have reviews been undertaken of the insert in the mefloquine (Lariam) package and the prescribing information used in Australia, if so what were the results and recommendations of the reviews, and what steps have been taken to implement the recommendations; (h) have reviews been undertaken of the insert in the mefloquine (Lariam) package and the prescribing information used in the United Kingdom, if so what were the results and recommendations of the reviews, and what steps have been taken to implement the recommendations; (i) have reviews been undertaken as regards the differences in the timing and content of the Canadian product monograph approved by the Department of Health Health Protection Branch as compared with Australian and British product monograph equivalents, if so what were the results and recommendations of the reviews, and what steps have been undertaken to implement these recommendations; and (j) what was the source of the mefloquine (Lariam) supplies used for the prophylaxis of Canadian troops deployed to Somalia? ...

With regard to the purchase of mefloquine from the manufacturer and the oversight of mefloquine by the Health Protection Branch as mandated by the Food and Drug Act: (a) did the Canadian Forces indicate to the manufacturer on the order form when ordering mefloquine for Somalia that it was for use under the Food and Drug Act's Lariam Safety Monitoring Study; when was the order submitted; and when was the shipment received; (b) was the Health Protection Branch informed by the manufacturer that the Canadian Forces had indicated on the order form that the mefloquine was being ordered under the authority of the Lariam Safety Monitoring Stu ...[+++]dy and that this mefloquine was apparently purchased for the Somalia deployment; and when was the Health Protection Branch so informed; (c) did the Health Protection Branch receive from the manufacturer a request to fast track licensing approval for mefloquine (Lariam), and was licensing approval granted prior to the end of the Canadian Forces deployment in Somalia; (d) what was the date the Health Protection Branch received the final results of the Lariam Safety Monitoring Study from the manufacturer, and the date of the receipt by the Health Protection Branch of the last submission of the Safety Monitoring Study's results prior to licensing approval; (e) did the Department of National Defence prepare an advisory note acknowledging that evidence provided to the Somalia Inquiry had mislead the Inquiry as to the status of mefloquine approvals for the mefloquine used in the Somalia deployment; was the advisory note forwarded to the Minister of National Defence; and what action was taken when the Minister was so informed?

...ug under Health Canada’s Lariam Safety Monitoring Study; (d) how many patients were the subject of monitoring reports received by Health Canada directly or indirectly from Roche under the Lariam Safety Monitoring Study; (e) what types of adverse events were identified by the Lariam Safety Monitoring Study up to the time the drug was licensed in 1993; (f) what is the total number of adverse events reported to Health Canada since the commencement of marketing in 1993; (g) how many adverse events were reported to Health Canada since the commencement of the marketing of the drug in 1993 involving each of the following reactions - hall ...[+++]ucinations, panic reaction, hyper alertness, extreme excitability, convulsions, aggressive reaction, marked restlessness, suicide, suicidal tendency, suicide attempt, thoughts of self harm, abnormal dreams, emotional disorder, irritability, nightmares, abnormal thinking, anxiety, depressed state, aggravated depression, light-headedness, anxiety attack, mood swings, abnormal crying, psychosis, delusion, speech disorder, concentration impaired, fear, euphoria, hysteria, paranoid psychosis, memory impairment, emotional disorder, murder; (h) what measures have been taken by Health Canada to ensure that it receives notice of such adverse drug events from doctors administering the drug; (i) what changes to the product monograph have been approved by Health Canada since licensing of the drug in 1993; (j) how many Canadian Forces members deployed on special missions abroad since 1990 have committed suicide (i) during the mission, (ii) following the mission, (iii) of these how many had been required to take mefloquine; and (k) what action has been undertaken to investigate the nature and extent of combined mefloquine exposure and post traumatic stress disorder in current and former members of the Canadian Forces members both regular and reserve who have at one time been deployed on special missions abroad? ...