Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Biotest Pharma GmbH, Landsteinerstrasse 5, 63303 Dreieich, Germany, Tel.: (49) 6103 801-0, fax: (49) 6103 801 150, Email: mail@biotest.com
Hepatect CP 50 IU/ml solution for infusion.
| Pharmaceutical Form |
|---|
|
Solution for infusion. The solution is clear or slightly opalescent and colourless to pale yellow. |
Human hepatitis B immunoglobulin.
Human protein 50 g/l of which at least 96% is IgG, with a content of antibodies to Hepatitis B virus surface antigen (HBs) of 50 IU/ml.
Each vial of 2 ml contains: 100 IU.
Each vial of 10 ml contains: 500 IU.
Each vial of 40 ml contains: 2000 IU.
Each vial of 100 ml contains: 5000 IU.
Distribution of IgG subclasses (approx. values):
IgG1: 59%
IgG2: 35%
IgG3: 3%
IgG4: 3%
The maximum IgA content is 2,000 micrograms/ml.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Human hepatitis B immunoglobulin |
Human hepatitis B immunoglobulin solution for infusion contains mainly immunoglobulin G (IgG) with a specifically high content of antibodies against hepatitis B virus surface antigen (HBs). It is used for the immunoprophylaxis of hepatitis B and the prevention of hepatitis B virus re-infection after liver transplantation for hepatitis B induced liver failure. |
| List of Excipients |
|---|
|
Glycine |
Hepatect CP is a ready-for-use solution for infusion provided in vials (Type II glass) with a stopper (bromobutyl) and a cap (aluminium):
Pack size of 1 vial with 2 ml, 10 ml, 40 ml or 100 ml solution.
Biotest Pharma GmbH, Landsteinerstrasse 5, 63303 Dreieich, Germany, Tel.: (49) 6103 801-0, fax: (49) 6103 801 150, Email: mail@biotest.com
PL 04500/0006
12/04/2015
| Drug | Countries | |
|---|---|---|
| HEPATECT | Austria, Brazil, Spain, Finland, Ireland, Israel, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom |
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