A coagulation factor viii formulation

A - Human Necessities – 61 – K

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A61K 38/37 (2006.01) A61P 7/04 (2006.01)

Patent

CA 2163112

The present invention relates to a pharmaceutical formulation for subcutaneous, intramuscular or intradermal administration comprising recombinant coagulation factor VIII and use thereof for manufacture of a medicament for treating haemophilia. The formulation comprises a highly purified recombinant coagulation factor VIII in a concentration of at least 1000 IU/ml, which gives surprisingly high levels of active factor VIII in the blood stream after subcutaneous, intramuscular or intradermal administration. The formulation is intended for treatment of haemophilia by subcutaneous, intramuscular or intradermal administration. The recombinant factor VIII is preferably a deletion derivative thereof, which can be used for the manufacture of a medicament for subcutaneous administration.

L'invention concerne une formulation pharmaceutique conçue pour une administration sous-cutanée, intramusculaire ou intradermique et comprenant le facteur VIII de coagulation recombiné, ainsi que son utilisation dans la préparation d'un médicament servant à traiter l'hémophilie. Cette formulation comprend un facteur VIII de coagulation recombiné extrêmement purifié, en concentration d'au moins 1000 IU/ml, produisant des niveaux inhabituellement élevés de facteur VIII actif dans la circulation sanguine après administration sous-cutanée, intramusculaire ou intradermique. Cette formulation s'adresse au traitement de l'hémophilie par administration sous-cutanée, intramusculaire ou intradermique. Le facteur VIII recombiné est, de préférence, un dérivé de délétion dudit facteur, qu'on peut utiliser dans la préparation d'un médicament s'administrant par voie sous-cutanée.

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