"愛默 " 人體血清白蛋白２５％注射液

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:

ALBUMIN HUMAN FRACTION V

可用日期:

傑特貝林有限公司 臺北市信義區基隆路1段333號16樓(1612室) (43836487)

ATC代码:

B05AA01

药物剂型:

注射劑

组成:

ALBUMIN HUMAN FRACTION V (1600000106) APPROXMG

每包单位数:

瓶裝附輸注器;;瓶裝未附輸注器

类:

菌　疫

处方类型:

限由醫師使用

厂商:

CSL BEHRING L.L.C. ROUTE 50 NORTH, 1201 N. KINZIE, BRADLEY, IL 60915, USA US

治疗领域:

albumin

疗效迹象:

低蛋白血症、休克、燒傷。

產品總結:

註銷日期: 2022/10/24; 註銷理由: 自請註銷; 有效日期: 2023/04/24; 英文品名: ALBUMINAR-25

授权状态:

已註銷

授权日期:

1990-02-06

资料单张

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responsibility and stating that Clondalkin
Pharma & Healthcare may proceed with production of a product matching
in content, copy, position and size.
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_CLONDALKIN PHARMA & HEALTHCARE GREENSBORO_
_1072 BOULDER RD. • GREENSBORO, NC 27409_
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CSL
12522-08
424028
09/13/12
2 x 20 1/4
09/20/12
Pasteurization (60°C for 10 hours)
Viral Reduction Studies (log
10
reduction)
Virus
Albumin (Human) 5%,
Albuminar
®
-5
HIV-1
>5.44, >6.38 and >6.31
BVDV
>6.01, >6.76 and >6.55
PrV
>7.30, >7.68 and >7.63
EMC
>7.38, >7.97 and >7.97
Virus
Albumin (Human) 25%,
Albuminar
®
-25
HIV-1
>5.50, >6.57 and >6.64
BVDV
>5.99, >5.81 and >5.32
PrV
>7.32, >7.20 and >7.42
EMC
>7.10, >7.89 and >7.87
R
X
ONLY
DESCRIPTION
Albumin (Human) 25%, Albuminar
®
-25 is a sterile
aqueous solution of albumin obtained from large
pools of adult human venous plasma by low tem-
perature controlled fractionation according to the
Cohn process. It is stabilized with 0.02 M sodium
acetyltryptophanate and 0.02 M sodium caprylate
and pasteurized at 60°C for 10 hours.
All Source Plasma used in the manufacture of this
product was tested by FDA-licensed Nucleic Acid
Testi