Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Biotest Pharma GmbH, Landsteinerstrasse 5, 63303 Dreieich, Germany, Tel.: (49) 6103 801-0, fax: (49) 6103 801 150, Email: mail@biotest.com
Pharmacotherapeutic group: immune sera and immunoglobulins / specific immunoglobulins / Hepatitis B immunoglobulin
ATC code: J06BB04
Human hepatitis B immunoglobulin contains mainly immunoglobulin G (IgG) with a specifically high content of antibodies against hepatitis B virus surface antigen (HBs).
The bioavailability of human hepatitis B immunoglobulin for intravenous use is complete and immediate. IgG is quickly distributed between plasma and extravascular fluid.
Hepatect CP has a half-life of about 22 days. This half-life may vary from patient to patient.
IgG and IgG-complexes are broken down in cells of the reticuloendothelial system.
Immunoglobulins are normal constituents of the human body. Repeated dose toxicity testing and embryo-foetal toxicity studies are impracticable due to induction of, and interference with antibodies. Effects of the product on the immune system of the newborn have not been studied.
Since clinical experience provides no hint for tumorigenic and mutagenic effects of immunoglobulins, experimental studies, particularly in heterologous species, are not considered necessary.
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