Avaxim 80 U Pediatric/Avaxim Adult Description

Avaxim 80 U Pediatric: The active ingredient is inactivated^** hepatitis A virus (GBM strain)^* 80 ELISA units^*** For one 0.5 mL dose.
^* Cultured on MRC-5 human diploid cells.
^** Adsorbed on hydrated aluminium hydroxide (quantity equivalent to 0.15 mg of Al³⁺).
^*** Antigenic units measured according to the manufacturer's internal method.
Excipient with known effect (see Precautions): Phenylalanine: 10 micrograms per 0.5 mL dose.
Avaxim Adult: Each 0.5 mL dose contains: Inactivated Adsorbed^** Hepatitis A virus^* 160 ELISA units^***, Aluminium hydroxide (expressed as aluminium) 0.3 mg, 2-phenoxyethanol 2.5 μL, Ethanol 2.5 μL, Formaldehyde 12.5 μg, Hanks 199 medium^**** up to 0.5 mL, Water for injections, Polysorbate 80, Hydrochloric acid and sodium hydroxide for pH adjustment, Less than 1 mmol of sodium and less than 1 mmol of potassium per dose.
^* GBM strain 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.
^**** Hanks 199 medium (without phenol red) is a complex mixture of amino acids (including phenylalanine), mineral salts, vitamin and other components, including potassium.
Excipient with known effect: Formaldehyde.
Excipients/Inactive Ingredients: Avaxim 80 U Pediatric: 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.