Quốc gia: Đài Loan
Ngôn ngữ: Tiếng Trung
Nguồn: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
FACTOR IX;;FACTOR II;;FACTOR X
醫療財團法人台灣血液基金會 台北市中正區南海路3號3樓 (01010553)
B02BD
凍晶乾燥注射劑
主成分 (After reconstitution) ; FACTOR IX (2012100700) IU; FACTOR II (8004002900) approx.IU; FACTOR X (8004003200) approx.IU
瓶裝;;瓶裝注射用水
菌 疫
限由醫師使用
CSL BEHRING GMBH EMIL-VON-BEHRING-STRASSE 76, 35041 MARBURG GERMANY DE
Blood coagulation factors
預防或治療一種或多種先天性或後天性第九、第二或第十凝血因子缺乏症。
註銷日期: 2017/04/12; 註銷理由: 許可證已逾有效期; 有效日期: 2016/01/31; 英文品名: "TBSF" Prothrombin Complex Concentrate
已註銷
2011-01-31
1 “TBSF” PROTHROMBIN COMPLEX CONCENTRATE TAIWAN NAME OF THE MEDICINE Human prothrombin complex, powder for injection. DESCRIPTION “TBSF” Prothrombin Complex Concentrate is prepared in cooperation with the “Self sufficiency” recommendation set forth by the Taiwan Department of Health, from pooled human plasma obtained from voluntary donors. “TBSF” Prothrombin Complex Concentrate is a sterile freeze-dried powder containing purified human coagulation factors II, IX and X and low levels of factors V and VII. The concentrate is prepared by adsorption of coagulation factors from plasma onto an ion-exchange medium followed by selective elution. The manufacturing process of “TBSF” Prothrombin Complex Concentrate contains dedicated and complementary steps to reduce the possibility of viral transmission including dry heat treatment (80°C for 72 hours) for viral inactivation and nanofiltration for virus removal. When reconstituted as recommended, each vial of “TBSF” Prothrombin Complex Concentrate contains the ingredients listed in Table 1. TABLE 1: Factor IX 500 IU Factor II approx. 500 IU Factor X approx. 500 IU Human plasma proteins (including low levels of factors V and VII) ≤ 500 mg Antithrombin III 25 IU Heparin sodium 192 IU Sodium + 112 mg Phosphate + 65 mg Citrate + 180 mg Chloride + 27 mg + present as sodium citrate, sodium phosphate and sodium chloride. The factors II, IX, X, the antithrombin III and the plasma proteins are all of human origin. The heparin sodium is of porcine origin. 2 PHARMACOLOGY PHARMACODYNAMICS The coagulation factors II, VII, IX and X, which are synthesised in the liver with the help of vitamin K, are commonly called the prothrombin complex. Factor VII is the zymogen of the active serine protease factor VIIa by which the extrinsic pathway of blood coagulation is initiated. The tissue factor-factor VIIa complex activates coagulation factors X and IX, whereby factor IXa and Xa are formed. With further activation of the coagulation cascade prothrombin (factor II) is Đọc toàn bộ tài liệu