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IMMUNINE Purified Factor IX Concentrate Virus- Inactivated

IMMUNINE Purified Factor IX Concentrate Virus- Inactivated
  • IMMUNINE Purified Factor IX Concentrate Virus- Inactivated
Description
The information contained in this page is intended for Indian healthcare professionals only.


Therapeutic indications :


Treatment and prophylaxis of bleeding episodes caused by congenital or acquired Factor IX Deficiency (Hemophilia B, Hemophilia B with factor IX inhibitors, acquired factor IX deficiency due to spontaneous development of factor IX inhibitors).


Features :


  • Use of pooled human plasma
  • Available in 600 IU dosage strength
  • To be stored at [2° - 8°C (36° - 46°F)] or at room temperature, not to exceed 25°C for a period of 6 months
  • 10 mL diluent vial


Safety and Efficacy :


Efficacious for the control and prevention of bleeding episodes in hemophilia B.


Important Risk Information for IMMUNINE Therapy


IMMUNINE is made from human plasma. It may carry a risk of transmitting infectious agents, e.g., viruses and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. Certain components used in the packaging of IMMUNINE contain natural rubber latex. Identification of the clotting defect as a Factor IX deficiency is essential before the administration of IMMUNINE is initiated. The development of inhibitors to Factor IX is a known complication of the treatment of patients with Hemophilia B. If expected plasma FIX levels are not attained, or bleeding is not controlled with an appropriate dose, test for the presence of inhibitors. IMMUNINE contains traces of human proteins other than FIX and the possibility exists that patients may develop hypersensitivity. Symptoms include hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis. Advise patients to discontinue use of the product and contact a physician if these symptoms occur.

The pulse rate should be determined before and during administration of IMMUNINE Should a significant increase in pulse rate occur, reducing the rate of administration or temporarily halting the injection usually allows the symptoms to disappear promptly.
Information is up-to-date: 13.08.2018

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