Basic Information
Xyntha Powder and Solvent for Solution for Injection 2000iu
INJECTION, POWDER, FOR SOLUTION
Regulatory Information
SIN13793P
April 28, 2010
Prescription Only
Therapeutic
INTRAVENOUS
August 10, 2023
May 30, 2025
XB02BD02
Company Information
PFIZER PRIVATE LIMITED
PFIZER PRIVATE LIMITED
Active Ingredients
Strength: 2000IU/vial
Detailed Information
Contraindications
**4.3 Contraindications** XYNTHA is contraindicated in patients with a known history of hypersensitivity to any of the constituents of the preparation and in patients with a known history of hypersensitivity to hamster proteins. XYNTHA has not been studied in patients with a known history of hypersensitivity to hamster proteins.
Indication Information
**4.1 Therapeutic indications** **4.1.1 Control of Bleeding Episodes in Hemophilia A** XYNTHA Antihemophilic Factor (Recombinant), Plasma/Albumin-Free is indicated for the control and prevention of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia). **4.1.2 Routine and Surgical Prophylaxis in Patients with Hemophilia A** XYNTHA Antihemophilic Factor (Recombinant), Plasma/Albumin-Free is indicated for routine and surgical prophylaxis in patients with hemophilia A. XYNTHA is appropriate for use in children of all ages, including newborns. XYNTHA does not contain von Willebrand factor, and therefore is not indicated in patients with von Willebrand's disease.