Nuwiq Description

Nuwiq 250 IU powder and solvent for solution for injection: Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Nuwiq 250 IU contains approximately 100 IU/ml of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Nuwiq 500 IU powder and solvent for solution for injection: Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Nuwiq 500 IU contains approximately 200 IU/ml of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Nuwiq 1000 IU powder and solvent for solution for injection: Each vial contains nominally 1000 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Nuwiq 1000 IU contains approximately 400 IU/ml of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Nuwiq 2000 IU powder and solvent for solution for injection: Each vial contains nominally 2000 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Nuwiq 2000 IU contains approximately 800 IU/ml of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
The potency (IU) is determined using the European Pharmacopoeia chromogenic assay. The specific activity of Nuwiq is approximately 9500 IU/mg protein.
Simoctocog alfa (human coagulation factor VIII (rDNA)) is a purified protein that has 1440 amino acids. The amino acid sequence is comparable to the 90 + 80 kDa form of human plasma factor VIII (i.e. B-domain deleted). Nuwiq is produced by recombinant DNA technology in genetically modified human embryonic kidney (HEK) 293F cells. No animal or human derived materials are added during the manufacturing process or to the final medicinal product.
Solvent: a clear, colourless liquid.
Excipient with known effect: One ml of reconstituted solution contains 7.35 mg sodium (18.4 mg sodium per vial).
Excipients/Inactive Ingredients: Powder: Sucrose, Sodium chloride, Calcium chloride dihydrate, Arginine hydrochloride, Sodium citrate dihydrate, Poloxamer 188.
Solvent: Water for injections.