Maa: Taiwan
Kieli: kiina
Lähde: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
FACTOR II;;FACTOR VII;;FACTOR IX;;FACTOR X
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)
B02BD01
凍晶注射劑
主成分 () ; FACTOR IX (2012100700) (400-600)IU (INTERNATIONAL UNIT); FACTOR II (8004002900) (NMT)U (UNIT); FACTOR VII (8004003000) (NMT)U (UNIT); FACTOR X (8004003200) (NMT)U (UNIT)
小瓶;;小瓶;;盒裝附注入器;;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, II, VII and X in combination
預防及治療乙型血友病及缺乏第九凝血因子。
有效日期: 2027/09/30; 英文品名: Profilnine 500 IU
2002-09-30
RTA #88 18 13/16” 13 11/16” BAR CODE Profilnine ® Factor IX Complex Solvent Detergent Treated/Nanofiltered DESCRIPTION Factor IX complex, Profilnine ® , is a solvent detergent treated, nanofiltered, sterile, lyophilized concentrate of coagulation factors IX, II, X, and low levels of factor VII. Profilnine is treated with a mixture of the organic solvent tri(n-butyl)phosphate (TNBP) and the non-ionic detergent polysorbate 80 (Solvent Detergent Mixture). The factor II content is not more than (NMT) 150 units * per 100 factor IX units, the factor X content is NMT 100 units per 100 factor IX units, and the factor VII content is NMT 35 units per 100 factor IX units. Profilnine is intended for intravenous administration only. Each vial is a single dose container and is labeled with the factor IX potency expressed in international units. Profilnine does not contain heparin and contains no preservatives. Profilnine contains few, if any, activated factors based on results from the non-activated partial thromboplastin time (NAPTT) test. 1, 2 Profilnine is prepared from pooled human plasma and purified by diethylaminoethyl (DEAE) cellulose adsorption. The risk of transmission of infective agents by Profilnine has been substantially reduced by donor selection procedures and virus screening of individual donations and plasma pools by serological and nucleic acid testing. In addition, specific, effective virus elimination steps such as nanofiltration 3 and solvent/detergent (tri-n-butyl phosphate/TNBP) treatment 4 have been incorporated into the Profilnine manufacturing process. Additional removal of some viruses occurs during the DEAE cellulose product purification step. The ability of the manufacturing process to eliminate virus from Profilnine was evaluated in the laboratory by intentionally adding virus to product just prior to the elimination step and monitoring virus removal. Table 1 shows the amounts of virus that can be removed by solvent detergent treatment, nanofiltration and purification by DEAE chromatography Lue koko asiakirja