Adynovate Description

ADYNOVATE 250 and 500 International Units (IU).
ADYNOVATE [rurioctocog alfa pegol, Recombinant Coagulation Factor VIII (rch), PEGylated] is supplied in single-use vials containing nominal potencies of 250 and 500 IU per vial with a diluent vial containing sterile water for injections for reconstitution to 2 mL.
The 2 mL diluent of water for injections is available for ADYNOVATE 250 and 500 IU.
The amounts of the inactive ingredients are constant in all strengths.
ADYNOVATE is formulated as a sterile, non-pyrogenic, white to off-white, lyophilised powder for intravenous injection after reconstitution with water for injections.
Physicochemical properties: Chemical structure: ADYNOVATE is comprised of 2,332 amino acids [molecular weight (MW) 280 kDa] covalently conjugated with a polyethylene glycol (PEG) reagent (MW 20 kDa).
Excipient(s) with known effect: Each vial of ADYNOVATE contains 0.45 mmol (10 mg) sodium (see Precautions).
Excipients/Inactive Ingredients: Calcium chloride dihydrate, Glutathione, Histidine, Mannitol, Polysorbate 80, Sodium chloride, Trehalose dihydrate, Trometamol, Water for injections (diluent).