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You are here: Home » eGM Resources » Health Information & Resources Portal|Home » RX Drug List (listed alphabetically) » Drug Reference (H's) » Hepatitis A Vaccine



DESCRIPTION

Havrix (Hepatitis A Vaccine, Inactivated) is a noninfectious hepatitis A vaccine developed and manufactured by Smith Kline Beecham Biologicals. The virus (strain HM175) is propagated in MAC5 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 supplied as a sterile suspension for intramuscular administration. The vaccine is ready for use without reconstitution; it must be shaken before administration to assure a uniform suspension. After shaking, the vaccine is a homogeneous white turbid suspension.

Each 1 mL adult dose of vaccine consists of not less than 1440 EL.U. of viral antigen, adsorbed on 0.5 mg of aluminum, as aluminum hydroxide.

There are two pediatric dose formulations, each with its own dosing schedule (see DOSAGE AND ADMINISTRATION). The formulations are: not less than 360 EL.U. of viral antigen/0.5 mL; not less than 720 EL.U. of viral antigen/0.5 mL. Each dose is adsorbed onto 0.25 mg of aluminum, as aluminum hydroxide.

The vaccine preparations also contain 0.5% (w/v) of 2-phenoxyethanol as a preservative. Other excipients are: amino acid supplement (0.3% w/v) in a phosphate-buffered saline solution and polysorbate 20 (0.05 mg/mL). Residual MAC5 cellular proteins (not more than 5 mcg/adult dose) and traces of formalin (not more than 0.1 mg/mL) are present.





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