HUMAN VARICELLA-ZOSTER IMMUNOGLOBULIN Solution for injection Ref.[9853] Active ingredients: Human varicela zoster immunoglobulin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Bio Products Laboratory Ltd., Elstree, WD6 3BX, United Kingdom

Pharmacodynamic properties

Pharmacotherapeutic group: immune sera and immunoglobulins: Human varicella immunoglobulin
ATC code: J06BB03

Human Varicella-Zoster Immunoglobulin contains mainly immunoglobulin G (IgG) with a specifically high content of antibodies against varicella-zoster virus.

Pharmacokinetic properties

Absorption and Distribution

Human Varicella-Zoster Immunoglobulin for intramuscular administration is bioavailable in the recipient’s circulation after a delay of 2-3 days.

Human Varicella-Zoster Immunoglobulin has a half-life of about 3-4 weeks. This half-life may vary from patient to patient.

Biotransformation and Elimination

IgG and IgG-complexes are broken down in cells of the reticuloendothelial system.

Preclinical safety data

Human Varicella-Zoster 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 rats and mice with immunoglobulins 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 an induction of, and interference with antibodies to human protein.

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