AVAXIM 160 U

Kraj: Izrael

Język: angielski

Źródło: Ministry of Health

Składnik aktywny:

HEPATITIS A VACCINES

Dostępny od:

MEDICI MEDICAL LTD, ISRAEL

Kod ATC:

J07BC02

Forma farmaceutyczna:

SUSPENSION FOR INJECTION

Skład:

HEPATITIS A VACCINES 160 AU / 0.5 ML

Droga podania:

I.M

Typ recepty:

Required

Wyprodukowano przez:

SANOFI PASTEUR, FRANCE

Grupa terapeutyczna:

HEPATITIS A, INACTIVATED, WHOLE VIRUS

Dziedzina terapeutyczna:

HEPATITIS A, INACTIVATED, WHOLE VIRUS

Wskazania:

For active immunisation against infection caused by Hepatitis A virus in adults and adolescents over the age of 15

Data autoryzacji:

2013-04-30

Charakterystyka produktu

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