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Liquid aqueous pharmaceutical composition of factor VII polypeptide
专利权人:
ノボ ノルディスク ヘルス ケア アクチェンゲゼルシャフト
发明人:
ジェンセン、マイケル・ベック,ハンセン、ビルセ・リッケガールド,コルンフェルト、トロエルス,ヤコブセン、キルステン・クラマー
申请号:
JP2006515737
公开号:
JP5306597B2
申请日:
2004.06.30
申请国别(地区):
JP
年份:
2013
代理人:
摘要:
The present invention is directed to liquid, aqueous pharmaceutical compositions containing Factor VII polypeptides, and methods for preparing and using such compositions, as well as vials containing such compositions, and the use of such compositions in the treatment of a Factor VII-responsive syndrome, e.g., bleeding disorders, including those caused by clotting Factor deficiencies (e.g. haemophilia A, haemophilia B, coagulation Factor VII deficiency); by thrombocytopenia or von Willebrand's disease, or by clotting Factor inhibitors, and intra cerebral haemorrhage, or excessive bleeding from any cause. The preparations may also be administered to patients in association with surgery or other trauma or to patients receiving anticoagulant therapy. More particularly, the invention relates to liquid compositions stabilised against chemical and/or physical degradation. The main embodiment is represented by a liquid, aqueous pharmaceutical composition comprising a Factor VII polypeptide (i); a buffering agent (ii) suitable for keeping pH in the range of from about 4.0 to about 9.0; at least one metal-containing agent (iii), wherein said metal is selected from the group consisting of first transition series metals of oxidation state +II, except zinc, such as chromium, manganese, iron, cobalt, nickel, and copper; and a non-ionic surfactant (iv).
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