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BeneFIX

Product SpecsDescription
Manufacturer NamePfizer
DescriptionBeneFIX is an antihemophilic factor (recombinant) indicated in adults and children with hemophilia B.
Indications for Adults: 

Control and Prevention of Bleeding Episodes

Yes

Perioperative Management

Yes

Routine Prophylaxis to Prevent or Reduce the Frequency of Bleeding Episodes

Yes
Indications for Children: 

Control and Prevention of Bleeding Episodes

Yes

Perioperative Management

Yes

Routine Prophylaxis to Prevent or Reduce the Frequency of Bleeding Episodes

Yes
Contraindications Nutrient in Cell CultureDo not use in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein.
Viral Safety ProcessChromatography, membrane nanofiltration
Product Half-Life18.8 ± 5.4 hours
Product Recovery Percentage Mean incremental recovery IR (IU/dL per IU/kg)Adults: 0.8 ± 0.2
Manufacturing MethodA purified protein produced by recombinant DNA technology
Storage Requirements/Shelf Life
  • Store at room temperature or under refrigeration, at a temperature of 2 to 30°C (36 to 86°F).
  • Do not freeze.
  • Do not use after the expiration date on the label.
  • After reconstitution the product should be used within 3 hours.
Nominal Vial Size & Diluent Volume250, 500, 1000, 2000, or 3000 IU/ 5 mL