"國血製劑益康"人冷凍乾燥複合凝血每原

Šalis: Taivanas

kalba: kinų

Šaltinis: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

Veiklioji medžiaga:

FACTOR IX;;FACTOR II;;FACTOR X

Prieinama:

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)

ATC kodas:

B02BD

Vaisto forma:

凍晶乾燥注射劑

Sudėtis:

主成分 (After reconstitution) ; FACTOR IX (2012100700) IU; FACTOR II (8004002900) approx.IU; FACTOR X (8004003200) approx.IU

Vienetai pakuotėje:

瓶裝;;瓶裝注射用水

Klasė:

菌　疫

Recepto tipas:

限由醫師使用

Pagaminta:

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

Gydymo sritis:

Blood coagulation factors

Terapinės indikacijos:

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。

Produkto santrauka:

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

Autorizacija statusas:

已註銷

Leidimo data:

2011-01-31

Pakuotės lapelis

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