"愛默" 人體血清白蛋白２０％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:

ALBUMIN HUMAN (eq to HUMAN ALBUMIN)

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 (eq to HUMAN ALBUMIN) (1600000101) MG

每包单位数:

玻璃瓶裝附輸注器

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: 2024/04/07; 英文品名: ALBUMINAR-20

授权状态:

已註銷

授权日期:

2018-10-12

资料单张

_APPROVED PROOFS - RETURN TO _
_ - ATTN: YOUR CSR_
_ TO MEET THE PRESS DATE THIS PROOF MUST BE SIGNED AND RETURNED BY:
____________________
_CUSTOMER'S SIGNATURE_
_DATE_
CUSTOMER
ITEM NUMBER
CLONDALKIN PHARMA & HEALTHCARE - JOB NUMBER
PROOF TO CUSTOMER DATE
_APPROVED AS IS_
_CHANGES REQUIRED (REPROOF)_
DIMENSIONS
SIDE 1 SIDE 2 ONE SIDED HEAD TO HEAD (HH) HEAD TO FOOT (HF)
The approved proof represents a contractual document between
Clondalkin Pharma & Healthcare and our
customers. By approving this proof, the customer is accepting
responsibility and stating that Clondalkin
Pharma & Healthcare may proceed with production of a product matching
in content, copy, position and size.
-All colors are representative of established color standards.
-The final product will match established color standards.
-Colors are indicated under proof of artwork.
NOTE: Proof paper not a representation of finished product.
** Please check appropriate box below. If changes are required, please
mark-up proof and return with comments.
_CLONDALKIN PHARMA & HEALTHCARE GREENSBORO_
_1072 BOULDER RD. • GREENSBORO, NC 27409_
_(336) 292-4555 • FAX [phone]_
CSL
12480-06
424027
09/13/12
2 x 20 1/4
09/20/12
R
X
ONLY
DESCRIPTION
Albumin (Human) 20%, Albuminar
®
-20 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 0.016 M sodium
acetyltryptophanate and 0.016 M sodium capry-
late and heated at 60°C for 10 hours.
All Source Plasma used in the manufacture of this
product was tested by FDA-licensed Nucleic Acid
Testing (NAT) for HBV, HCV, and HIV-1 and found
to be nonreactive (negative).
Albuminar
®
-20 is a solution containing in each 100
mL 20 grams of human albumin, osmotically equiv-
alent to 400 mL of normal human plasma. The pH
of the solution is adjusted with sodium bicarbon-
ate, sodium hydroxide, or acetic acid. Approximate
concentrations of significant electrolytes per liter
are: sodium