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Immunate

Immunate
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Description
The information contained in this page is intended for Indian healthcare professionals only.


Therapeutic indications :


Immunate is a highly purified, double virus inactivated, plasma derived Factor VIII/von Willebrand Factor (VWF) complex concentrate, suitable for the treatment of haemophilia A and von Willebrand Disease with FVIII deficiency.


Features :


  • Use of pooled human plasma
  • Available in 250 IU dosage strength-
  • Active substance - Factor VIII - 50IU/ml and vWF -25IU/ml
  • 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
  • 5 mL diluent vial

Safety and Efficacy :


Efficacious for the control and prevention of bleeding episodes in hemophilia A and Von Willebrand disease.


Important Risk Information for IMMUNATE Therapy

IMMUNATE 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 IMMUNATE contain natural rubber latex. Identification of the clotting defect as a Factor VIII deficiency is essential before the administration of IMMUNATE is initiated. The development of inhibitors to Factor VIII is a known complication of the treatment of patients with Hemophilia A. If expected plasma FVIII levels are not attained, or bleeding is not controlled with an appropriate dose, test for the presence of inhibitors. IMMUNATE contains traces of human proteins other than FVIII 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 IMMUNATE 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.
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Information is up-to-date: 05.11.2018

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