HAVRIX (Hepatitis A Vaccine) is a sterile suspension of inactivated virus for intramuscul ar administration. The virus (strain HM1 75) is propagated in MRC - 5 human diploid cells. After removal of the cell culture medium, the cells are lysed to form a suspension. This suspension is purified through ultrafiltration and gel permeation chromatography procedures.
Treatment of this lysate with formalin ensures viral inactivation. Viral antigen activity is referenced to a standard using an enzyme linke d immunosorbent assay (ELISA), and is therefore expressed in terms of ELISA Units (EL.U.). Each 1 - mL adult dose of vaccine contains 1440EL.U. of viral antigen, adsorbed on 0.5 mg of aluminum as aluminum hydroxide.
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