Advate Description

250 IU: 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.
500 IU: Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 100 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
1000 IU: Each vial contains nominally 1000 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 200 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
1500 IU: Each vial contains nominally 1500 IU human coagulation factor VIII (rDNA), octocog alfa. ADVATE contains approximately 300 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.