CSC Pharmaceuticals International




Havrix Vaccines


Havrix Vaccines

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 1440
EL.U. of viral antigen, adsorbed on

0.5
mg of aluminum as aluminum hydroxide




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