The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.
This is duplicated text of a letter from Talecris Biotherapeutics, Inc. (Bayer Inc., Canadian distributor and importer of the product)
Contact the company for a copy of any references, attachments or enclosures. |
PUBLIC COMMUNICATION
Health Canada Endorsed Important Safety Information on
Gamunex (Immune Globulin Intravenous [Human], 10%) |
October 19, 2005
| Subject: |
Association of Gamunex® (Immune Globulin Intravenous [Human], 10%) with Hemolytic Reactions |
Talecris Biotherapeutics, Inc., in collaboration with Health Canada, is informing healthcare professionals in Canadian hospitals of important new safety information concerning Gamunex® (Immune Globulin Intravenous [Human], 10%).
Gamunex® belongs to a group of biological medicines derived from human plasma known as IGIV products that treat patients with a compromised immune system or idiopathic thrombocytopenic purpura (ITP). It is administered in hospitals by infusion through the veins.
- Hemolytic reactions (reactions which involve the breakdown of some red blood cells) have been reported rarely in patients receiving IGIV products.
- Cases have now been reported following the use of Gamunex®.
Symptoms of hemolytic reactions can vary depending on their severity but may include generalized weakness, lightheadedness and pale complexion and sometimes dark urine and jaundice. Should a patient be experiencing any of these symptoms following treatment with an IGIV product, consult your specialist to confirm the diagnosis and determine if any treatment is necessary.
Any suspected adverse reaction can also be reported to:
Drug Safety and Medical Information
Bayer Inc.
77 Belfield Rd.
Toronto, ON M9W 1G6
Tel: 1-800-265-7382
Fax: 1-866-232-0565
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
OTTAWA, Ontario, K1A 0K9
Tel.: (613) 957-0337 or Fax: (613) 957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Tel: 866 234-2345
Fax: 866 678-6789
cadrmp@hc-sc.gc.ca
For other inquiries, please refer to contact information:
Marketed Health Products Directorate
email: MHPD_DPSC@hc-sc.gc.ca
Tel.: (613) 954-6522
Fax.: (613) 952-7738
The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.
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Should you have any questions or require additional information regarding Gamunex®, please contact your health care provider or Bayer Medical Information at 1-800-265-7382.
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