AVAXIM VACCINE

Țară: Singapore

Limbă: engleză

Sursă: HSA (Health Sciences Authority)

Ingredient activ:

HEPATITIS A VIRUS (INACTIVATED)

Disponibil de la:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Codul ATC:

J07BC02

Dozare:

160 u/0.5 ml

Forma farmaceutică:

INJECTION

Compoziție:

HEPATITIS A VIRUS (INACTIVATED) 160 u/0.5 ml

Calea de administrare:

INTRAMUSCULAR

Tip de prescriptie medicala:

Prescription Only

Produs de:

SANOFI PASTEUR

Statutul autorizaţiei:

ACTIVE

Data de autorizare:

1999-01-06

Prospect

AVAXIM 160 U, SUSPENSION FOR INJECTION IN A PREFILLED SYRINGE 
Hepatitis A vaccine (inactivated, adsorbed) 
1.  NAME OF THE MEDICINAL PRODUCT 
  AVAXIM 160 U, suspension for injection in a prefilled syringe Hepatitis 
A vaccine (inactivated, adsorbed) 
2.  QUALITATIVE AND QUANTITATIVE COMPOSITION 
  One dose (0.5 ml) contains: 
  Hepatitis A virus, GBM strain* (inactivated**) .................. 160 units*** 
  * cultured on MRC-5 human diploid cells 
  ** adsorbed on aluminium hydroxide (quantity corresponding to 0.3 
mg of aluminium) 
  ***  antigen  units  measured  using  an  in-house  manufacturer’s 
reference. 
  For excipients, see section 6.1 
3.  PHARMACEUTICAL FORM 
  Suspension for injection in a prefilled syringe. 
4.  CLINICAL PARTICULARS 
  4.1.  THERAPEUTIC INDICATIONS 

 This  vaccine  is  indicated  for  active  immunisation  against 
infection caused by the hepatitis A virus in adolescents from 16 
years of age and in adults. 

 This vaccine should be administered in accordance with official 
recommendations. 
  4.2.  POSOLOGY AND METHOD OF ADMINISTRATION 

 POSOLOGY 

 The recommended dosage for subjects from 16 years of age 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 from 16 years 
of  age  and  in  adults,  a  booster  dose  should  be  administered, 
preferably between 6 and 12 months after the first vaccination 
and  can  be  administered  up  to  36  months  after  the  first 
vaccination  (see  section  5.1).  It  is  estimated  that  anti-VHA 
antibodies  persist  several  years  (at  least  10  years)  after  the 
second dose (bo

Caracteristicilor produsului

SG/AVA160/0223/CCDSV10
1
AVAXIM 160 U
, SUSPENSION FOR INJECTION IN A PREFILLED SYRINGE
Hepatitis A vaccine (inactivated, adsorbed)
1. NAME OF THE MEDICINAL PRODUCT
AVAXIM 160 U, suspension for injection in prefilled syringe
Hepatitis A vaccine (inactivated, adsorbed)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (0.5 mL) contains:
Hepatitis A virus, GBM strain* (inactivated) **
.................................160 ELISA units***
* Cultured on MRC-5 human diploid cells
** Adsorbed on hydrated aluminium hydroxide (0.3 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 a prefilled syringe.
The hepatitis A vaccine (inactivated, adsorbed) is a turbid and
whitish 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 from 16 years of age and in adults.
This vaccine should be administered in accordance with official
recommendations.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
SG/AVA160/0223/CCDSV10
2
POSOLOGY
The recommended dosage for subjects from 16 years of age 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 from 16 years of age and in adults, a second
dose (booster) should
be administered, preferably between 6 and 12 months after the first
vaccination and can
be administered up to 36 months after