Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Octapharma AB, Lars Forssells gata 23, 112 75 Stockholm, Sweden
Vihuma 250 IU powder and solvent for solution for injection.
Vihuma 500 IU powder and solvent for solution for injection.
Vihuma 1000 IU powder and solvent for solution for injection.
Vihuma 2000 IU powder and solvent for solution for injection.
Vihuma 2500 IU powder and solvent for solution for injection.
Vihuma 3000 IU powder and solvent for solution for injection.
Vihuma 4000 IU powder and solvent for solution for injection.
| Pharmaceutical Form |
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Powder and solvent for solution for injection. Powder: white to off-white friable powder. Solvent: a clear, colourless liquid. |
Vihuma 250 IU powder and solvent for solution for injection: Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), simoctocog alfa. Vihuma 250 IU contains approximately 100 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Vihuma 500 IU powder and solvent for solution for injection: Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), simoctocog alfa. Vihuma 500 IU contains approximately 200 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Vihuma 1000 IU powder and solvent for solution for injection: Each vial contains nominally 1000 IU human coagulation factor VIII (rDNA), simoctocog alfa. Vihuma 1000 IU contains approximately 400 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Vihuma 2000 IU powder and solvent for solution for injection: Each vial contains nominally 2000 IU human coagulation factor VIII (rDNA), simoctocog alfa. Vihuma 2000 IU contains approximately 800 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Vihuma 2500 IU powder and solvent for solution for injection: Each vial contains nominally 2500 IU human coagulation factor VIII (rDNA), simoctocog alfa. Vihuma 2500 IU contains approximately 1000 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Vihuma 3000 IU powder and solvent for solution for injection: Each vial contains nominally 3000 IU human coagulation factor VIII (rDNA), simoctocog alfa. Vihuma 3000 IU contains approximately 1200 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Vihuma 4000 IU powder and solvent for solution for injection: Each vial contains nominally 4000 IU human coagulation factor VIII (rDNA), simoctocog alfa. Vihuma 4000 IU contains approximately 1600 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 Vihuma 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). Vihuma 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.
Excipient with known effect: One mL of reconstituted solution contains 7.35 mg sodium (18.4 mg sodium per vial).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Coagulation factor VIII |
Activated factor VIII acts as a cofactor for activated factor IX, accelerating the conversion of factor X to activated factor X (factor Xa). Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor VIII:C. By replacement therapy the plasma levels of factor VIII are increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies. |
| List of Excipients |
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Powder: Sucrose Solvent: Water for injections |
Each pack contains:
Octapharma AB, Lars Forssells gata 23, 112 75 Stockholm, Sweden
EU/1/16/1168/001
EU/1/16/1168/002
EU/1/16/1168/003
EU/1/16/1168/004
EU/1/16/1168/005
EU/1/16/1168/006
EU/1/16/1168/007
Date of first authorisation: 13 February 2017
| Drug | Countries | |
|---|---|---|
| VIHUMA | Austria, Estonia, Ireland, Lithuania, Poland |
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