Product Name: BeneFIX R/T

Formulation & Concentration: [Coagulation Factor IX (Recombinant)]

Manufacturer: Pfizer

Indications
BeneFIX®, Coagulation Factor IX (Recombinant), is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with hemophilia B (congenital factor IX deficiency or Christmas disease). BeneFIX®, Coagulation
Factor IX (Recombinant), is indicated for peri-operative management in adult and pediatric patients with hemophilia B. BeneFIX®, Coagulation Factor IX (Recombinant), is NOT indicated for: (1) treatment of other factor deficiencies (e.g., factors II, VII, VIII, and X), (2) treatment of hemophilia A patients with inhibitors to factor VIII, (3) reversal of coumarin-induced anti coagulation, (4) treatment of bleeding due to low levels of liver-dependent coagulation factors

Vial Size NDC # Size
250 IU 58394-633-03 5ml
500 IU 58394-634-03 5ml
1000 IU 58394-635-03 5ml
2000 IU 58394-636-03 5ml

Shelf Life
24 months

Storage
Product as packaged for sale: BeneFIX®, Coagulation Factor IX (Recombinant), can be stored at room temperature or under refrigeration, at a temperature of 2 to 30°C (36 to 86°F) . Do not use BeneFIX® after the expiration date on the label. Do not freeze to prevent damage to the diluent syringe. Product after reconstitution: The product does not contain a preservative and should be used within 3 hours

Full Prescribing Information:
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