〝基立福〞 第九凝固因子複合體注射劑

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)

Ingrédients actifs:

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

Disponible depuis:

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)

Code ATC:

B02BD01

forme pharmaceutique:

凍晶注射劑

Composition:

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)

Unités en paquet:

小瓶;;小瓶;;盒裝附注入器;;護蓋

classe:

菌　疫

Type d'ordonnance:

限由醫師使用

Fabriqué par:

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

Domaine thérapeutique:

coagulation factor IX, II, VII and X in combination

indications thérapeutiques:

預防及治療乙型血友病及缺乏第九凝血因子。

Descriptif du produit:

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

Date de l'autorisation:

2002-09-30

Notice patient

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