国家: 台湾
语言: 中文
来源: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
FACTOR IX
台灣綠十字股份有限公司 台北市大同區承德路三段二四四號六樓 (71621557)
B02BD04
凍晶注射劑
FACTOR IX (2012100700) 400-625IU (I
盒裝附注入器;;小瓶;;護蓋
菌 疫
限由醫師使用
GRIFOLS BIOLOGICALS LLC 13111 TEMPLE AVENUE, CITY OF INDUSTRY, CA 91746, USA US
coagulation factor IX
預防及治療乙型血友病及缺乏第九凝血因子。
有效日期: 2028/05/20; 英文品名: ALPHANINE SD COAGULATION FACTOR IX(HUMAN)
1998-11-30
RTA #88 18 13/16” 13 11/16” BAR CODE Coagulation Factor IX (Human) AlphaNine ® SD Solvent Detergent Treated and Virus Filtered DESCRIPTION Coagulation Factor IX (Human), AlphaNine ® SD, is a purified, solvent detergent treated, virus fiItered preparation of Factor IX derived from human plasma. 1 It contains a minimum of 150 lU Factor lX/mg protein; levels of Factor VII (proconvertin), Factor II (prothrombin) and Factor X (Stuart-Prower Factor) which are below the limit of detection (less than 0.04 Factor VII unit, less than 0.05 Factor II unit, and less than 0.05 Factor X unit per IU Factor IX). AlphaNine SD is a steriIe, IyophiIized preparation intended for intravenous administration only. Each vial is a single dose container. AlphaNine SD contains not more than (NMT) 0.04 unit of heparin, NMT 0.2 mg of dextrose, NMT 1.0 μg polysorbate 80 and NMT 0.l0 μg tri(n-butyl) phosphate/IU of Factor IX. CLINICAL PHARMACOLOGY AlphaNine SD is a purified formulation of Factor IX containing not less than 150 IU Factor IX activity/mg of total protein. 2 AlphaNine SD contains non-therapeutic levels of Factor II, Factor VII and Factor X. Thrombogenicity of AlphaNine SD in animals is markedly lower than that of Factor IX Complex, Profilnine ® Heat-Treated. Five lots of AlphaNine SD (three lots of non-virus filtered product and two lots of virus filtered product) failed to show any evidence of thrombogenicity when tested directly in the Wessler rabbit stasis model for thrombogenicity 3-6 at a dose of 200 IU Factor IX/kg body weight. When various lots of AlphaNine SD were further tested at doses between 300 and 650 IU Factor IX/kg, only 5 out of 40 animals (12.5%) showed evidence of thrombus formation (Wessler scores of +1, +2, +1, +1, +1 out of +4 maximum). In comparison, Factor IX Complex concentrate, Profilnine, was thrombogenic in 100% of the animals tested at a dose of 100 IU Factor IX/kg. At a dose of 200 IU Factor IX/kg body weight in a porcine model, the heptane heat-treated formulation of this product (AlphaNine) 阅读完整的文件