STABLE PHARMACEUTICAL COMPOSITION CONTAINING FACTOR VIII

摘要

THE INVENTION RELATES TO A STABLE SOLID PHARMACEUTICAL COMPOSITION COMPRISING FACTOR VIII. SUCH A COMPOSITION IS DEVOID OF AMINO ACIDS AND COMPRISES: (A) FACTOR VIII; (B) A SURFACTANT; (C)CALCIUM CHLORIDE; (D)SUCROSE; (E)SODIUM CHLORIDE; (F)TRISODIUM CITRATE; AND (G) A BUFFER; AND HAS A PH FROM 6 TO 8 PRIOR TO LYOPHILISATION AND AFTER RECONSTITUTION IN WATER FOR INJECTION. THE INVENTION ALSO RELATES TO THE LIQUID PHARMACEUTICAL COMPOSITION OBTAINABLE AFTER DILUTION OF SAID STABLE SOLID PHARMACEUTICAL COMPOSITION WITH STERILE WATER OPTIONALLY CONTAINING SODIUM CHLORIDE.