ADYNOVATE 500 IU/2 ml powder and solvent for solution for injection: Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol, corresponding to a concentration of 250 IU/ml after reconstitution with 2 ml solvent.
The potency (International Units) is determined using the chromogenic assay. The specific activity of ADYNOVATE is approximately 4000-6500 IU/mg protein. The active substance rurioctocog alfa pegol is a covalent conjugate of the protein octocog alfa* with a 20 kDa polyethylene glycol (PEG).
* Human factor VIII produced by recombinant DNA technology in a Chinese Hamster Ovary (CHO) cell line.
Excipient(s) with known effect: Each powder vial contains 0.45 mmol (10 mg) sodium, see Precautions.
Excipients/Inactive Ingredients: Powder: Mannitol, Trehalose dihydrate, Histidine, Glutathione, Sodium chloride, Calcium chloride dihydrate, Tris(hydroxymethyl)aminomethane, Polysorbate 80.
Solvent: Sterilised water for injections.