País: Israel
Idioma: anglès
Font: Ministry of Health
HEPATITIS A VACCINES
MEDICI MEDICAL LTD, ISRAEL
J07BC02
SUSPENSION FOR INJECTION
HEPATITIS A VACCINES 160 AU / 0.5 ML
I.M
Required
SANOFI PASTEUR, FRANCE
HEPATITIS A, INACTIVATED, WHOLE VIRUS
HEPATITIS A, INACTIVATED, WHOLE VIRUS
For active immunisation against infection caused by Hepatitis A virus in adults and adolescents over the age of 15
2013-04-30
1. NAME OF THE MEDICINAL PRODUCT AVAXIM 160 U, suspension for injection in a pre-filled syringe. Hepatitis A vaccine (inactivated, adsorbed). 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One 0.5 millilitre dose contains: Hepatitis A virus, GBM strain (inactivated) 1, 2 ……160 EU 3 1 produced in human diploid (MRC-5) cells 2 adsorbed on aluminium hydroxide, hydrated (0.3 milligrams Al 3+ ) 3 ELISA Unit. In the absence of an international standardised reference, the antigen content is expressed using an in- house reference Excipient(s) with known effect: Ethanol anhydrous………………….2.5 microlitres Phenylalanine………………………10 micrograms For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection in a pre-filled syringe. Hepatitis A vaccine (inactivated, adsorbed) is a cloudy and white suspension. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS This vaccine is indicated for active immunisation against infection caused by the hepatitis A virus in adolescents over the age of 15 and in adults. The vaccine does not protect against infection caused by hepatitis B, hepatitis C, or hepatitis E viruses, or any other known liver pathogens. Transmission of the hepatitis A virus is usually through the ingestion of contaminated water or food. Persons in contact with contaminated subjects are usually infected through the oro-faecal route. The possibility of transmission by blood or by sexual con (oral-anal relations) has also been demonstrated. This vaccine should be administered in accordance with official recommendations. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dosage for subjects over the age of 15 is 0.5 ml. The initial protection is obtained after one single injection. In order to obtain a long-term protection against infections caused by the Hepatitis A virus, in adolescents over the age of 15 and in adults, a booster dose should be administered, preferably between 6 and 12 months after the first vaccination and can be adminis Llegiu el document complet