Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2014 Publisher: Bio Products Laboratory Limited, Dagger Lane, Elstree, Hertfordshire, WD6 3BX, United Kingdom Tel: +44 (0)20 8957 2200 Fax: +44 (0)20 8957 2608 Email: info@bpl.co.uk
Pharmacotherapeutic group: immune sera and immunoglobulins: Human rabies immunoglobulin
ATC code: J06BB05
Human rabies immunoglobulin contains mainly immunoglobulin G (IgG) with a specifically high content of antibodies against rabies virus.
Human rabies immunoglobulin for intramuscular use is bioavailable in the recipient’s circulation after a delay of 2-3 days. Human rabies 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 rabies 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-foetal toxicity studies are impracticable due to the induction of, and interference with, antibodies to human protein. Clinical experience provides no sign of tumourigenic and mutagenic effects of immunoglobulins.
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