“國血製劑益康”高純度第九凝血因子注射劑

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)

Thành phần hoạt chất:

FACTOR IX;;HEPARIN;;ANTITHROMBIN III;;PLASMA PROTEIN;;SODIUM (ACETATE);;PHOSPHATE;;CITRATE;;CHLORIDE

Sẵn có từ:

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)

Mã ATC:

B02BD

Dạng dược phẩm:

凍晶乾燥注射劑

Thành phần:

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

Các đơn vị trong gói:

小瓶;;小瓶

Lớp học:

菌　疫

Loại thuốc theo toa:

限由醫師使用

Sản xuất bởi:

CSL BEHRING GMBH EMIL-VON-BEHRING STRASSE 76,35041 MARBURG GERMANY DE

Khu trị liệu:

Blood coagulation factors

Chỉ dẫn điều trị:

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。

Tóm tắt sản phẩm:

有效日期: 2027/07/16; 英文品名: "TBSF" High Purity Factor IX Concentrate

Ngày ủy quyền:

2007-07-16

Tờ rơi thông tin

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