Source: Health Products Regulatory Authority (IE) Revision Year: 2019 Publisher: CSL Behring GmbH, Emil-von-Behring-Strasse 76, 35041 Marburg, Germany
Tetagam P, prefilled syringeSolution for injection for intramuscular use.
| Pharmaceutical Form |
|---|
|
Solution for injection for intramuscular use. Tetagam P is a clear solution. The colour can vary from colourless to pale-yellow up to light brown during shelf life. |
Active ingredient: Human tetanus immunoglobulin.
1 ml solution contains: Human protein 100–170 mg thereof immunoglobulins at least 95% with antibodies to tetanus toxin at least 250 IU.
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Tetanus immunoglobulin |
Human tetanus immunoglobulin contains mainly immunoglobulin G (IgG) with a specifically high content of antibodies against the toxin produced by the bacteria clostridium tetanus. |
| List of Excipients |
|---|
|
Aminoacetic acid (glycine) |
Immediate container:
SCF syringe of colourless tube glass, glass type I according to Ph. Eur.
Presentations:
Pack with 1 prefilled syringe with 1 ml.
Pack with 10 prefilled syringes with 1 ml.
Pack with 1 prefilled syringe with 2 ml.
Not all pack sizes may be marketed
CSL Behring GmbH, Emil-von-Behring-Strasse 76, 35041 Marburg, Germany
PA0800/009/002
Date of first authorisation: 17th October 2014
Date of last renewal: 16th October 2019
| Drug | Countries | |
|---|---|---|
| TETAGAM-P | Austria, Estonia, Hong Kong, Ireland, Malta, Romania, Tunisia, Turkey, South Africa |
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