Xyntha



Xyntha

Product Specs Xyntha
Manufacturer Name Pfizer
Indications XYNTHA® Antihemophilic Factor (Recombinant) is an injectable medicine that is used to help control and prevent bleeding in people with hemophilia A.
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 proteins.
Stabilizer in Final Formulation Sucrose
Viral Safety Process Chromatography, affinity chromatography; solvent/detergent nanofiltration
Product Half-Life Initial Visit (n=30): 11.2 ± 5.0 hours
Month 6 (n=25): 11.8 ± 6.2 hours
Pre-surgery (n=8): 16.7 ± 5.4 hours
Product Recovery Percentage Mean incremental recovery IR (IU/dL per IU/kg) Initial Visit (n=30): 2.15 ± 0.44
Month 6 (n=25): 2.47 ± 0.84
Pre-surgery (n=8): 2.17 ± 0.47
Storage Requirements/Shelf Life
  • Refrigerate at 2° to 8°C (36° to 46°F) for up to 36 months from the date of manufacture until the expiration date
    stated on the label.
  • May be stored at room temperature not to exceed 25°C (77°F) for up to 3 months. At the end of the 3-month period, immediately use or return the product to refrigerated storage.
  • After room temperature storage it can be returned to the refrigerator until the expiration date. Do not store at room temperature and return it to the refrigerator more than once.
  • Do not freeze. The diluent syringe may be stored at 2° to 25°C (36° to 77°F).
  • Do not use after the expiration date.
  • Avoid prolonged exposure to light.
  • Store the reconstituted solution at room temperature prior to administration.
  • Administer within 3 hours after reconstitution.
    		•
    Nominal Vial Size & Diluent Volume 250, 500, 1000, 2000 IU/4 mL


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