Source: Health Products Regulatory Authority (IE) Revision Year: 2019 Publisher: CSL Behring GmbH, Emil-von-Behring-Strasse 76, 35041 Marburg, Germany
Pharmacotherapeutic group: immune sera and immunoglobulins, human tetanus immunoglobulin
ATC-code: J06BB02
Human tetanus immunoglobulin contains mainly immunoglobulin G (IgG) with a defined high content of specific antibodies against the toxin produced by the bacteria Clostridium tetani.
Human tetanus immunoglobulin for intramuscular administration is bioavailable in the recipient’s circulation after a delay of 2 to 3 days. Human tetanus immunoglobulin has a half-life of about 3 to 4 weeks. This half-life may vary from patient to patient. IgG and IgG-complexes are broken down in cells of the reticuloendothelial system.
Tetagam P contains tetanus immunoglobulin as active ingredient which is derived from human plasma and acts like endogenous constituent of plasma. Single dose i.m. application of immunoglobulin to various animal species did not reveal toxic effects.
Preclinical studies with repeated dose applications (chronic toxicity, cancerogenicity and mutagenicity) cannot be reasonably performed in conventional animal models due to the development of antibodies following the application of heterologous human proteins.
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