HAVRIX SUMMARY
HAVRIX (Hepatitis A Vaccine, Inactivated) is a noninfectious hepatitis A vaccine developed and manufactured by GlaxoSmithKline Biologicals. The virus (strain HM175) is propagated in MRC5 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. HAVRIX contains a sterile suspension of inactivated virus; viral antigen activity is referenced to a standard using an enzyme linked immunosorbent assay (ELISA), and is therefore expressed in terms of ELISA Units (EL.U.).
HAVRIX is indicated for active immunization of persons >/=2 years of age against disease caused by hepatitis A virus (HAV).
HAVRIX will not prevent hepatitis caused by other agents such as hepatitis B virus, hepatitis C virus, hepatitis E virus, or other pathogens known to infect the liver.
Immunization with HAVRIX is indicated for those people desiring protection against hepatitis A. Primary immunization should be completed at least 2 weeks prior to expected exposure to HAV.
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