Krajina: Taiwan
Jazyk: čínština
Zdroj: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
ALBUMIN HUMAN FRACTION V
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)
B05AA01
注射劑
ALBUMIN HUMAN FRACTION V (1600000106) APPROXMG
瓶裝附輸注器;;瓶裝未附輸注器
菌 疫
限由醫師使用
CSL BEHRING L.L.C. ROUTE 50 NORTH, 1201 N. KINZIE, BRADLEY, IL 60915, USA US
albumin
低蛋白血症、休克、燒傷。
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
已註銷
1990-02-06
_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 (336) 292-2767_ 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 Prečítajte si celý dokument