"愛默 " 人體血清白蛋白２５％注射液

Quốc gia: Đài Loan

Ngôn ngữ: Tiếng Trung

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

Thành phần hoạt chất:

ALBUMIN HUMAN FRACTION V

Sẵn có từ:

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)

Mã ATC:

B05AA01

Dạng dược phẩm:

注射劑

Thành phần:

ALBUMIN HUMAN FRACTION V (1600000106) APPROXMG

Các đơn vị trong gói:

瓶裝附輸注器;;瓶裝未附輸注器

Lớp học:

菌　疫

Loại thuốc theo toa:

限由醫師使用

Sản xuất bởi:

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

Khu trị liệu:

albumin

Chỉ dẫn điều trị:

低蛋白血症、休克、燒傷。

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

已註銷

Ngày ủy quyền:

1990-02-06

Tờ rơi thông tin

_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
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