Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Sweden
ALPROLIX 250 IU powder and solvent for solution for injection.
ALPROLIX 500 IU powder and solvent for solution for injection.
ALPROLIX 1000 IU powder and solvent for solution for injection.
ALPROLIX 2000 IU powder and solvent for solution for injection.
ALPROLIX 3000 IU powder and solvent for solution for injection.
| Pharmaceutical Form |
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Powder and solvent for solution for injection. Powder: lyophilised, white to off-white powder or cake. |
ALPROLIX 250 IU powder and solvent for solution for injection: Each vial contains nominally 250 IU eftrenonacog alfa. After reconstitution, each mL of solution for injection contains approximately 50 IU eftrenonacog alfa.
ALPROLIX 500 IU powder and solvent for solution for injection: Each vial contains nominally 500 IU eftrenonacog alfa. After reconstitution, each mL of solution for injection contains approximately 100 IU eftrenonacog alfa.
ALPROLIX 1000 IU powder and solvent for solution for injection: Each vial contains nominally 1000 IU eftrenonacog alfa. After reconstitution, each mL of solution for injection contains approximately 200 IU eftrenonacog alfa.
ALPROLIX 2000 IU powder and solvent for solution for injection: Each vial contains nominally 2000 IU eftrenonacog alfa. After reconstitution, each mL of solution for injection contains approximately 400 IU eftrenonacog alfa.
ALPROLIX 3000 IU powder and solvent for solution for injection: Each vial contains nominally 3000 IU eftrenonacog alfa. After reconstitution, each mL of solution for injection contains approximately 600 IU eftrenonacog alfa.
The potency (International Units) is determined using the European Pharmacopoeia one stage clotting test against an in-house standard that is referenced to the WHO factor IX standard. The specific activity of ALPROLIX is 55-84 IU/mg protein.
Eftrenonacog alfa (recombinant human coagulation factor IX, Fc fusion protein (rFIXFc)) has 867 amino acids. It is a high purity factor product produced by recombinant DNA technology in a human embryonic kidney (HEK) cell line, without the addition of any exogenous human- or animal-derived protein in the cell culture, purification or final formulation.
Excipient with known effect: 0.3 mmol (6.4 mg) sodium per vial.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Eftrenonacog alfa |
Eftrenonacog alfa is a long-acting, fully recombinant, fusion protein comprising human coagulation factor IX covalently linked to the Fc domain of human immunoglobulin G1, and produced by recombinant DNA technology. Haemophilia B is an X-linked hereditary disorder of blood coagulation due to decreased levels of factor IX and results in bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma. By replacement therapy the plasma level of factor IX is 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: Sodium chloride |
Each pack contains:
Pack size of 1.
Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Sweden
EU/1/16/1098/001
EU/1/16/1098/002
EU/1/16/1098/003
EU/1/16/1098/004
EU/1/16/1098/005
Date of first authorisation: 12 May 2016
| Drug | Countries | |
|---|---|---|
| ALPROLIX | Austria, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Turkey, United Kingdom |
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