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One dose (0.5 mL) contains: Hepatitis A virus, GBM strain* (inactivated)** 160 ELISA units***.
*Cultured on MRC-5 human diploid cells.
**Adsorbed on hydrated aluminium hydroxide (0.3 milligrams of Al3+).
***In the absence of an international standardised reference, the antigen content is expressed using an in-house reference.
Excipient(s) with known effect: Less than 1 mmol of sodium and less than 1 mmol of potassium per dose: Ethanol 2.5 microlitres; Phenylalanine 10 micrograms per 0.5 mL dose.
Excipients/Inactive Ingredients: 2-Phenoxyethanol, ethanol, formaldehyde, and Hanks 199 medium*, water for injections, polysorbate 80, hydrochloric acid and sodium hydroxide for pH adjustment.
*Hanks 199 medium (without phenol red) is a complex mixture of amino acids (including phenylalanine), mineral salts, vitamins, and other components, including potassium.
