CSC Pharmaceuticals International

Havrix Vaccines

Havrix Vaccines

HAVRIX (Hepatitis A Vaccine)
is a sterile suspension of inactivated virus for
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 1440
EL.U. of viral antigen, adsorbed on

mg of aluminum as aluminum hydroxide

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