Pays: Taïwan
Langue: chinois
Source: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
ANTITHROMBIN III;;SODIUM (ACETATE);;FACTOR IX;;CITRATE;;HEPARIN;;CHLORIDE;;PLASMA PROTEIN;;PHOSPHATE
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 () ; FACTOR IX (2012100700) I.U.; HEPARIN (2012400500) 50~140I.U.; ANTITHROMBIN III (2012401400) I.U.; SODIUM (ACETATE) (4008009600) M.MOL/L; CHLORIDE (4026000500) M.MOL/L; PHOSPHATE (4026001400) M.MOL/L; CITRATE (4026003000) M.MOL/L; PLASMA PROTEIN (8004000700) <=20 mgMG
小瓶;;小瓶
菌 疫
限由醫師使用
CSL BEHRING GMBH EMIL-VON-BEHRING STRASSE 76,35041 MARBURG GERMANY DE
Blood coagulation factors
用以治療和預防,因缺乏第九凝血因子而引起之B型血友病相關的出血病症。
有效日期: 2027/07/16; 英文品名: "TBSF" High Purity Factor IX Concentrate
2007-07-16
TBSF FIX TW PI 5.03 Page 1 of 24 TBSF High Purity Factor IX Concentrate Taiwan Imported Biological Product Permit No. 000843 Department of Health NAME OF THE MEDICINE Human coagulation factor IX, powder for injection. DESCRIPTION TBSF High Purity Factor IX 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 High Purity Factor IX Concentrate is a sterile freeze-dried powder containing purified human coagulation factor IX. The factor IX in TBSF High Purity Factor IX Concentrate is purified using ion-exchange and heparin affinity chromatography to remove other vitamin K-dependent factors such as factors II, VII and X. The manufacturing process of TBSF High Purity Factor IX Concentrate includes a solvent detergent (tributyl phosphate and polysorbate 80) treatment and a viral filtration step to reduce the potential for viral transmission, particularly of hepatitis A virus. When reconstituted as recommended, each vial nominally contains 500 IU of factor IX, 50 140 IU of heparin sodium, 12.5 IU of antithrombin III, 20 mg of plasma proteins, 120 mmol/L sodium, 20 mmol/L phosphate, 10 mmol/L citrate and 50 mmol/L chloride. PHARMACOLOGY Human factor IX is a single chain glycoprotein with a molecular weight of 68 kilodalton. It is synthesised in the liver, like other vitamin K-dependent proteins, and participates in the intrinsic blood coagulation pathway. Factor XIa activates factor IX, which then, in the presence of factor VIIIa, activates factor X. This leads to the conversion of prothrombin to thrombin and the formation of a fibrin clot. Haemophilia B (also known as Christmas disease) is an X-linked recessive blood coagulation disorder. It is caused by reduced factor IX activity through either insufficient or abnormal synthesis of the factor IX protein. Clinical symptoms of haemophilia B include skin bruising, excessive haemorrhage after trauma, and spontane Lire le document complet