BeneFIX



BeneFIX

Product Specs BeneFIX
Manufacturer Name Pfizer
Description BeneFIX 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 Culture Do 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 Process Chromatography, membrane nanofiltration
Product Half-Life 18.8 ± 5.4 hours
Product Recovery Percentage Mean incremental recovery IR (IU/dL per IU/kg) Adults: 0.8 ± 0.2
Manufacturing Method A purified protein produced by recombinant DNA technology
Storage Requirements
  • Store at room temperature or refrigerated, at 2°C to 30°C (36°F to 86°F).
  • Do not freeze.
  • Do not use BeneFIX after the expiration date on the label.
  • Use within 3 hours of reconstitution.
    		•
    Shelf Life For products labeled for room temperature storage, the shelf life is 24 months when stored at 2°C to 30°C (not to exceed 30°C).
  • For products labeled for refrigerated storage, the shelf life is 36 months when stored at 2°C-8°C; if stored at room temperature (2°C-30°C; not to exceed 30°C) prior to the expiration date, then the shelf life becomes 6 months.
    		•
    Nominal Vial Size & Diluent Volume 250, 500, 1000, 2000, or 3000 IU/ 5 mL


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