Advate

Product Specs	Description
Manufacturer Name	Takeda
Description	ADVATE is a recombinant antihemophilic factor indicated for use in children and adults 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 lifethreatening hypersensitivity reactions, including anaphylaxis, to mouse or hamster protein or other constituents of the product (mannitol, trehalose, sodium chloride, histidine, Tris, calcium chloride, polysorbate 80, and/or glutathione).
Stabilizer in Final Formulation	mannitol, trehalose, sodium chloride, histidine, Tris, calcium chloride, polysorbate 80, and glutathione.
Viral Safety Process	Immunoaffinity chromatography; solvent/detergent
Product Half-Life	12.0 ± 4.2 hours
Product Recovery Percentage Mean incremental recovery IR (IU/dL per IU/kg)	2.6 ± 0.5
Storage Requirements/Shelf Life	In powder form, refrigerate at 2°C to 8°C (36°F to 46°F). Do not freeze. May be stored at room temperature (up to 30°C [86°F]) for a period of up to 6 months not to exceed the expiration date. Do not use beyond the expiration date printed on the label. After storage at room temperature, the product must not be returned to the refrigerator.
Nominal Vial Size & Diluent Volume	2 mL, 5mL