ZUTECTRA Solution for injection Ref.[27695] Active ingredients: Hepatitis B, purified antigen

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

Product name and form

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.

Qualitative and quantitative composition

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
Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

Biotest Pharma GmbH, Landsteinerstrasse 5, D-63303 Dreieich, Germany, Tel.: +49 6103 801-0, Fax: +49 6103 801-150, Email: mail@biotest.com

Marketing authorization dates and numbers

EU/1/09/600/001

30/11/2009 / 16/09/2014

Drugs

Drug Countries
ZUTECTRA Austria, Estonia, Spain, France, Ireland, Israel, Lithuania, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom

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