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Final drug product of a plasma protein Processes to prepare the final drug product to improve the long-term stability of a plasma protein and to treat hemophilia and use of a final drug product
Final drug product of a plasma protein Processes to prepare the final drug product to improve the long-term stability of a plasma protein and to treat hemophilia and use of a final drug product
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机译：血浆蛋白的最终药物制备最终药物以改善血浆蛋白的长期稳定性并治疗血友病和使用最终药物的过程
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PCT No. PCT/SE96/00419 Sec. 371 Date Nov. 26, 1997 Sec. 102(e) Date Nov. 26, 1997 PCT Filed Mar. 9, 1996 PCT Pub. No. WO96/30041 PCT Pub. Date Oct. 3, 1996A final drug product comprises a plasma protein selected from the group consisting of coagulation factor VIII and factor IX, in an aqueous solution. The concentration of oxygen in the solution is reduced and/or the solution contains an antioxidant. The solution further contains a carbohydrate in a concentration of at least 350 mg/ml. The protein activity after storage for at least 6 months at a temperature of from 0 DEG C. to 40 DEG C. is from 70% to 130% of its initial value. In a process for preparing the final drug product and a method for improving the long-term stability of coagulation factor VIII or factor IX in an aqueous solution, a carbohydrate is included in the solution in a concentration of at least 350 mg/ml and the solution is stored in its final container under an oxygen-reduced atmosphere or includes an antioxidant.
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