AVAXIM ADULT

Pays: Indonésie

Langue: indonésien

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

Unités en paquet:

DUS,1 PREFILLED SYRINGE @ 0,5 ML (1 DOSIS)

Date de l'autorisation:

2022-11-05

Résumé des caractéristiques du produit

AVAXIM ADULT
muscle of the buttocks (due to the presence of varying
amounts of adipose tissue) nor intradermally, since
these modes of administration may induce a lesser
degree of immune response.
LEAFLET KEMASAN: INFORMASI BAGI PENGGUNA
AVAXIM ADULT
INACTIVATED ADSORBED HEPATITIS A VIRUS
Anda pernah pingsan dengan suntikan sebelumnya
INACTIVATED ADSORBED
HEPATITIS A VIRUS
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.5 mL dose contains:
-
Inactivated Adsorbed** Hepatitis A virus*
. ................................................................
160
ELISA
units***
-
Alumunium 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
miligrams 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, viamin and other
components, including potassium.
PHARMACEUTICAL FORM
Suspension for injection (0.5 mL) in a prefilled syringe.
The hepatitis A vaccine (inactivated, adsorbed) is a
turbid and whitish suspension.
THERAPEUTIC INDICATIONS
This medicinal product is a VACCINE.
-
This
medicinal
product
is
recommended
in
the
prevention of infection caused by hepatitis A virus in
adults over the age of 16 years.
-
Vaccination against hepatitis A is recommended for
subjects exposed to hepatitis A virus risks such as:
*
Non-immunized