Description
The hepatitis A vaccine (inactivated, adsorbed) is a turbid and whitish suspension.
Avaxim 80 U Pediatric: Hepatitis A virus, GBM strain* (inactivated) ** 80 ELISA unit*** for one dose of 0.5 mL.
* Cultured on MRC5 human diploid cells.
** Adsorbed on hydrated aluminium hydroxide (0.15 milligrams of Al3+).
*** In the absence of an international standardised reference, the antigen content is expressed using an in-house reference.
Avaxim 160 U: 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 Al).
*** 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 Medium 199* , 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.