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Pharmacovigilance
Dear Sir or Madam, if you have any questions concerning Adverse Drug Reactions (ADR) of our products please ask us at any time. We will try to help you and provide you with further information. If you report about an ADR-case we will furthermore ask you for documentation of the case. Further Information:  Contact Pharmacovigilance Department   Which ADR reports are important?   How to report an ADR?   What will medac do with your report? Urgent questions concerning pharmacovigilance out of working hours   Abbreviations, specific terms	Diese Seite auf Deutsch printlayout

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Contact Pharmacovigilance Department	top of page
EU-Qualified Person for Pharmacovigilance medac GmbH Referat Arzneimittelsicherheit Theaterstrasse 6 22880 Wedel E-Mail: drugsafety@medac.de Phone: +49 (0)4103 8006-777 Fax: +49 (0)4103 8006-9130

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Which ADR reports are important?	top of page
In general we are interested in all reports of adverse drug reactions of our drugs, independent if expected, unexpected, serious, frequent or rare. Special attention is paid to serious and unexpected cases. A continuous surveillance of the benefit and risk of our drugs is only possible by the help of all concerned persons.

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How to report an ADR?	top of page
It would be very helpful for us if you could report your case on the ADR-form in order to achieve a standardized recording. We will mail the ADR-form on request to you. If it is more convenient for you, please use this online form: ADR_form.pdf Please send the filled-in form to us and add if necessary further information, e.g. pseudonymous doctor`s letter.

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What will medac do with your report?	top of page
Your report will be assessed by a physician or pharmacist of medac and concerning patient`s name pseudonymously registered in our data base. Normally you receive a confirmation letter from us and - if requested - further information. According to the legislation we are obliged to report ADRs to the health authorities in a fixed interval, if at least a possible causality between the symptoms and one of our drug is stated by the physician / pharmacist or the pharmacovigilance department medac. If necessary further measures will be initiated by medac, for example labelling changes.
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Urgent questions concerning pharmacovigilance out of working hours	top of page
Out of working hours you can reach us for urgent questions concerning pharmacovigilance. In this case please contact medac by phone +49-41038006-0. You will be informed about the phone numbers to reach us. In case of acute symptoms please call an ambulance.
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Abbreviations, specific terms	top of page
ADR = adverse drug reaction Adverse reaction = A response to a medicinal product which is noxious and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease or for the restoration, correction or modification of physiological function. Serious drug adverse reaction = An adverse reaction which results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect. Unexpected drug reaction = An adverse reaction, the nature, severity or outcome of which is not consistent with the summary of product characteristics.   If you are interested you are allowed to copy and hand out this text provided that you mention the source (Pharmacovigilance Department, medac GmbH).

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