Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2022 Publisher: Bio Products Laboratory Limited, Dagger Lane, Elstree, Hertfordshire, WD6 3BX, United Kingdom
Pharmacotherapeutic group: immune sera and immunoglobulins: human tetanus immunoglobulin
ATC code: J06BB02
Human tetanus immunoglobulin contains mainly immunoglobulin G (IgG) with a specifically high content of antibodies against the toxin produced by the bacteria Clostridium tetani.
Human tetanus immunoglobulin for intramuscular use is bioavailable in the recipient’s circulation after a delay of 2-3 days.
Human tetanus immunoglobulin has a half-life of about 3–4 weeks. This half-life may vary from patient to patient.
IgG and IgG-complexes are broken down in cells of the reticuloendothelial system.
Human Tetanus Immunoglobulin is a preparation of human plasma proteins, so safety testing in animals is not particularly relevant to the safety of use in man. Acute toxicity studies in rat and mouse showed species specific reactions which bear no relevance to administration in humans. Repeated dose toxicity testing and embryo-fetal toxicity studies are impracticable due to the induction of, and interference with antibodies to human protein. Clinical experience provides no evidence of tumourigenic and mutagenic effects of immunoglobulins.
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