AVAXIM 80 U PEDIATRIC

Krajina: Indonézia

Jazyk: indonézština

Zdroj: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktívna zložka:

HEPATITIS A IMMUNOGLOBULIN HUMAN

Dostupné z:

AVENTIS PHARMA - Indonesia

INN (Medzinárodný Name):

HEPATITIS A IMMUNOGLOBULIN HUMAN

Dávkovanie:

80 UNIT/0,5 ML

Forma lieku:

CAIRAN INJEKSI

Počet v balení:

DUS, 1 PREFILLED SYRINGE @ 0,5 ML

Výrobca:

SANOFI PASTEUR - France

Dátum Autorizácia:

2018-03-29

Súhrn charakteristických

AVAXIM 80 U PEDIATRIC
INACTIVATED ADSORBED
HEPATITIS A VACCINE
COMPOSITION
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 Al
3+
).
*** antigenic units measured according to the manufacturer’s
internal method
Excipient with known effect (see section Special warnings and
precautions for use ):
Phenylalanine…
............................................................................................................
10 micrograms
Per 0.5 mL dose
For the full list of excipients, see section List of excipients.
PHARMACEUTICAL FORM
Suspension for injection in pre-filled syringe.
The hepatitis A vaccine (inactivated, adsorbed) is a turbid and
whitish suspension.
THERAPEUTIC INDICATIONS
AVAXIM 80U Pediatric comes in the form of a suspension for injection
in a prefilled syringe (0.5 ml) This
vaccine is recommended in the prevention of infection induced by
hepatitis A virus in children 12 months to
15 years inclusive.
This vaccine should be administered in accordance with official
recommendations.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_PRIMARY-VACCINATION : _Primary vaccination is achieved with one
vaccine dose of 0.5 ml.
•
_BOOSTER_
One booster dose of 0.5 mL is recommended in order to provide
long-term protection. This booster will
preferably be administered 6 to 36 months following the primary
vaccination dose, but administration will
be possible until 7 years after this primary vaccination..
Available data on vaccination with AVAXIM 80 U PEDIATRIC show that
after the two doses of the initial
vaccination schedule, no other booster vaccination is necessary in
immunocompetent individuals, which is
in agreement with the official recommendations.
It is estimated that anti-VHA antibodies persist several years (beyond
10 years) after the second dose
(booster).
METHOD OF ADMINISTRATION
This vaccine must be adminis