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Pharmacotherapeutic Group: Immune sera and immunoglobulins-Hepatitis B immunoglobulin. ATC Code: J06BB04.
Pharmacology: Pharmacodynamics: Human hepatitis B immunoglobulin contains mainly immunoglobulin G (IgG) with a specifically high content of antibodies against hepatitis B virus surface antigen (HBs).
Paediatric population: No specific studies of efficacy and safety are available on paediatric population.
Pharmacokinetics: The bioavailability of human hepatitis B immunoglobulin for intravenous use is complete and immediate.
IgG is quickly distributed between plasma and extravascular fluid.
Human hepatitis B 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 the reticuloendothelial system.
Toxicology: Preclinical safety data: Immunoglobulins are normal constituents of the human body. The safety of VENBIG with respect to the components of the viral inactivation treatment, a well established method, has been assessed through a bibliographic review. No preclinical safety testing was therefore performed using VENBIG.
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