Advate



Advate

Product Specs Advate
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


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