Alphanate

Product Specs	Description
Manufacturer Name	Grifols
Indications	Control and prevention of bleeding in adult and pediatric patients with hemophilia A. Surgical and/or invasive procedures in adult and pediatric patients with von Willebrand Disease in whom desmopressin (DDAVP) is either ineffective or contraindicated. It is not indicated for patients with severe VWD (Type 3) undergoing major surgery.
Contraindications	Do not use in patients who have manifested lifethreatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components.
Ratio of VWF: RCO to FVIII	1:3:1
Viral Safety Process	Precipitation with 3.5% polyethylene glycol (PEG), heparin affinity chromatography and lyophilization; solvent/detergent, dry heat treatment (80°C, 72 hours)
Product Half-Life	17.9 ± 9.6 hours for adult subjects with severe Hemophilia A VWF:RCo, 6.91 (range: 3.8 to 16.22) hours FVIII:C 20.92 (range: 7.19 to 32.2) hours VWF:Ag 12.8 (range: 10.34 to 17.45)hours
Product Recovery Percentage	96.7 ± 14.5% at 10 minutes post-infusion
Manufacturing Methods	Pooled human plasma
Storage Requirements/Shelf Life	Store under refrigeration at temperatures between 2 and 8 °C (34 to 46 °F). Do not freeze to prevent damage to diluent vial. May be stored at room temperature not to exceed 30 ºC for up to 2 months.
Nominal Vial Size & Diluent Volume	250 IU FVIII/5 mL 500 IU FVIII/5 mL 1000 IU FVIII/10 mL 1500 IU FVIII/10 mL 2000 IU FVIII/10 mL

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