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compositionproductmonographxyntha
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title:
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      v: Xyntha® Lyophilized Powder for Reconstitution in a Vial 250, 500, 1000, or 2000 IU in single-use vials and one pre-filled diluent syringe containing 4 mL 0.9% Sodium Chloride for reconstitution* Antihemophilic Factor (Recombinant) [BDDrFVIII] For Intravenous Injection Antihemorrhagic Blood Coagulation Factor VIII Reference Market: Canada Xyntha® Moroctocog alfa Antihemophilic Factor (Recombinant) [BDDrFVIII] SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form / Strength Clinically Relevant Nonmedicinal Ingredients Intravenous Infusion Available as 250, 500, 1000, or 2000 IU in single-use vials. Polysorbate 80 (0.4 mg/vial ), Sucrose (12 mg/vial), L-Histidine (6 mg/vial), Calcium Chloride Dihydrate (1 mg/vial), Sodium Chloride (72 mg/vial) [after reconstitution with diluent]. Xyntha is prepared by a modified process that eliminates any exogenous human- or animal-derived protein in the cell culture process, purification, or final formulation. The purification process uses a series of chromatography steps, one of which is based on affinity chromatography using a synthetic peptide affinity ligand. The process also includes a solvent-detergent viral inactivation step and a virus-retaining nanofiltration step. The labelled potency of Xyntha is based on the European Pharmacopoeial chromogenic substrate assay, in which the Pfizer In-House Recombinant Factor VIII Potency Reference Standard has been calibrated to the WHO International Standard using the one-stage clotting assay. This method of potency assignment is intended to harmonize Xyntha with clinical monitoring using a one-stage clotting assay. INDICATIONS AND CLINICAL USE Xyntha, Antihemophilic Factor (Recombinant) [BDDrFVIII], indicated for the control and prevention of hemorrhagic episodes and for routine and surgical prophylaxis in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia). Xyntha does not contain von Willebrand factor and hence is not indicated in von Willebra…

organizationwyeth
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    city:
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    country:
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