Source: Υπουργείο Υγείας (CY) Revision Year: 2021 Publisher: SANOFI PASTEUR, 14 Espace Henry Vallee, 69007 Lyon, France
AVAXIM 160 U, suspension for injection in prefilled syringe.
Hepatitis A vaccine (inactivated, adsorbed).
| Pharmaceutical Form |
|---|
|
Suspension for injection in a prefilled syringe. The hepatitis A vaccine (inactivated, adsorbed) is a turbid and whitish suspension. |
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.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Hepatitis A, inactivated vaccine |
Inactivated virus of a strain which was originally derived by further serial passage of a proven attenuated strain. The virus is grown, harvested, highly purified, formalin inactivated, and then adsorbed onto amorphous aluminum hydroxyphosphate sulphate. |
| List of Excipients |
|---|
|
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 |
0.5 ml of suspension in prefilled syringe (type I glass) with a plunger stopper (chlorobutyl or bromobutyl), and an attached needle. Box of 1, 5, 10 or 20.
0.5 ml of suspension in prefilled syringe (type I glass) with a plunger stopper (chlorobutyl or bromobutyl), without needle. Box of 1 or 10.
0.5 ml of suspension in prefilled syringe (type I glass) with a plunger stopper (chlorobutyl or bromobutyl), with 1 or 2 separate needles. Box of 1 or 10.
All pack sizes may not be marketed.
SANOFI PASTEUR, 14 Espace Henry Vallee, 69007 Lyon, France
17602
Date of first authorisation: 13/03/1998
iDate of latest renewal: 12/05/2009
| Drug | Countries | |
|---|---|---|
| AVAXIM | Brazil, Canada, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong, Ireland, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, United Kingdom, South Africa |
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