Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Biotest Pharma GmbH, Landsteinerstrasse 5, D-63303 Dreieich, Germany, Tel.: +49 6103 801-0, Fax: +49 6103 801-150, Email: mail@biotest.com
Zutectra 500 IU solution for injection in pre-filled syringe.
| Pharmaceutical Form |
|---|
|
Solution for injection. The solution is clear and pale yellow or light brown. |
One pre-filled syringe of 1 ml contains Human hepatitis B immunoglobulin 500 IU.
Human protein 150 mg/ml of which at least 96% is IgG, with a content of antibodies to hepatitis B virus surface antigen (HBs) of 500 IU/ml.
Distribution of IgG subclasses:
IgG1: 59%
IgG2: 35%
IgG3: 3%
IgG4: 3%
The maximum IgA content is 6,000 micrograms/ml.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Hepatitis B, purified antigen |
Hepatitis B vaccine induces specific humoral antibodies against hepatitis B virus surface antigen (anti-HBsAg). Hepatitis B vaccine has been recognized as the first anti-cancer vaccine because it can prevent primary liver cancer. |
| List of Excipients |
|---|
|
Glycine |
One ml solution in a pre-filled syringe (Type I glass) with a stopper (bromobutyl) and a tip cap (bromobutyl rubber).
Pack size of five syringes in a blistered pack.
Biotest Pharma GmbH, Landsteinerstrasse 5, D-63303 Dreieich, Germany, Tel.: +49 6103 801-0, Fax: +49 6103 801-150, Email: mail@biotest.com
EU/1/09/600/001
30/11/2009 / 16/09/2014
| Drug | Countries | |
|---|---|---|
| ZUTECTRA | Austria, Estonia, Spain, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
