〝基立福〞 第九凝固因子複合體注射劑

国家: 台湾

语言: 中文

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

有效成分:

FACTOR II;;FACTOR VII;;FACTOR IX;;FACTOR X

可用日期:

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)

ATC代码:

B02BD01

药物剂型:

凍晶注射劑

组成:

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)

每包单位数:

小瓶;;小瓶;;盒裝附注入器;;護蓋

类:

菌　疫

处方类型:

限由醫師使用

厂商:

GRIFOLS BIOLOGICALS LLC 13111 TEMPLE AVENUE, CITY OF INDUSTRY, CA 91746, USA US

治疗领域:

coagulation factor IX, II, VII and X in combination

疗效迹象:

預防及治療乙型血友病及缺乏第九凝血因子。

產品總結:

有效日期: 2027/09/30; 英文品名: Profilnine 500 IU

授权日期:

2002-09-30

资料单张

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