Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 50 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
The potency (International Units) is determined using the European Pharmacopoeia chromogenic assay. The specific activity of ADVATE is approximately 4,000‑10,000 IU/mg protein.
Octocog alfa (human coagulation factor VIII (rDNA)) is a purified protein that has 2332 amino acids. It is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells. Prepared without the addition of any (exogenous) human‑ or animal‑derived protein in the cell culture process, purification or final formulation.
Excipients with known effect: 0.45 mmol sodium (10 mg) per vial.
Excipients/Inactive Ingredients: Powder: Mannitol, Sodium chloride, Histidine, Trehalose, Calcium chloride, Trometamol, Polysorbate 80, Glutathione (reduced).
Solvent: Sterilised water for injections.