AVAXIM 80U PEDIATRIC SUSPENSION FOR INJECTION IN PREFILLED SYRINGE 80U0.5ml

Страна: Сингапур

Език: английски

Източник: HSA (Health Sciences Authority)

Активна съставка:

HEPATITIS A VIRUS (INACTIVATED)

Предлага се от:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

АТС код:

J07BC02

дозиране:

80 ANTIGEN UNITS

Лекарствена форма:

INJECTION, SUSPENSION

Композиция:

HEPATITIS A VIRUS (INACTIVATED) 80 ANTIGEN UNITS

Начин на приложение:

INTRAMUSCULAR

Вид предписание :

Prescription Only

Произведено от:

SANOFI PASTEUR

Статус Оторизация:

ACTIVE

Дата Оторизация:

2010-07-08

Листовка

AVAXIM 80 U PEDIATRIC 

1. NAME OF THE MEDICINAL PRODUCT  
AVAXIM 80 U PEDIATRIC, suspension for injection in prefilled syringe 
Inactivated Hepatitis A vaccine, adsorbed 

AVAXIM 80 U PEDIATRIC, suspension for injection in multidose vial 
Inactivated Hepatitis A vaccine, adsorbed 

. 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
Hepatitis A virus (GBM strain)*, inactivated**…………………80
U*** 
        For 
one 
dose 
of 
0.5ml 

*    
cultured on MRC5 human diploid cells 
**   adsorbed on aluminium hydroxide (quantity corresponding to
0.15mg of 
aluminium) 
*** 
Antigen units expressed using an in-house reference 

For excipients, see chapter 6.1 

The vaccine may contain traces of neomycin. 

3. PHARMACEUTICAL FORM 
Suspension for injection in prefilled syringe. 
Suspension for injection in multidose vial. 

4. CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS 
AVAXIM 80 U PEDIATRIC is indicated for active immunization against
infection 
caused by hepatitis A virus in children aged from 12 months to 15
years.  

The vaccine should be administered in accordance with official
recommendations.

4.2 POSOLOGY AND METHOD OF ADMINISTRATION 
_POSOLOGY _
Primary vaccination is achieved with one single dose of vaccine. 
The recommended 
dosage is 0.5ml for each injection.  In order to provide
long-term protection, a booster 
dose is recommended within the 6 to 18 month period following the
initial dose. 

HAV antibody persistence following vaccination is not currently
available.  Available 
data suggest that HAV antibodies persist at protective levels up to
ten years after primary 
vaccination. 

_METHOD OF ADMINISTRATION _
The vaccine must be injected by the intramuscular route in the deltoid
region. 

In exceptional cases, the vaccine may be administered by the
subcutaneous route in 
patients suffering from thrombocytopaenia or in patients at risk of
haemorrhage. 

4.3 CONTRA-INDICATIONS 
Usual

Данни за продукта

SG/AVA80/0620/CCDSV13
1
AVAXIM 80 U PEDIATRIC
1. NAME OF THE MEDICINAL PRODUCT
AVAXIM 80 U PEDIATRIC, suspension for injection in prefilled syringe
Inactivated Hepatitis A vaccine, adsorbed
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Hepatitis A virus, GBM strain*, (inactivated)**…………………80
ELISA units***
for one dose of 0.5 mL.
*
Cultured on MRC5 human diploid cells
**
Adsorbed on hydrated aluminium hydroxide (0.15 milligrams of Al
3+)
***
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
3. PHARMACEUTICAL FORM
Suspension for injection in prefilled syringe.
The hepatitis A vaccine (inactivated, adsorbed) is a turbid and
whitish suspension.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
AVAXIM 80 U PEDIATRIC is indicated for active immunization against
infection caused
by hepatitis A virus in children aged from 12 months to 15 years.
The vaccine should be administered in accordance with official
recommendations.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
SG/AVA80/0620/CCDSV13
2
POSOLOGY
_ _
_Paediatric population _
•
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
dose
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 th