Vivaxim

Држава: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

Hepatitis a virus antigen; Salmonella typhi Vi polysaccharide

Доступно од:

Sanofi-Aventis Australia Pty Ltd

Класа:

Medicine Registered

Информативни летак

VIVAXIM
®

_Salmonella typhi Vi polysaccharide and inactivated hepatitis A virus
antigen vaccine_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about VIVAXIM
®
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines, including vaccines,
have risks and benefits. Your doctor
has weighed the risks of you having
VIVAXIM
®
 against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
VACCINE, ASK YOUR DOCTOR, NURSE OR
PHARMACIST.
KEEP THIS LEAFLET. YOU MAY NEED TO
READ IT AGAIN.
WHAT VIVAXIM
®
 IS
USED FOR
VIVAXIM
®
 is a vaccine used to help
prevent Typhoid fever and Hepatitis
A disease in adults over the age of 16
years who are at risk of these
diseases.
_HOW IT WORKS_
VIVAXIM
®
 works by causing your
body to produce its own protection
against typhoid fever and hepatitis A
infection. It does this by making
substances called antibodies in the
blood, which fight the typhoid
bacteria and hepatitis A viruses. If a
vaccinated person comes into contact
with the typhoid or hepatitis A
organisms, the body is usually ready
to destroy them.
Your body usually takes two weeks
after vaccination to develop
protection against typhoid fever and
hepatitis A infection.
Initial protection is provided by one
dose of VIVAXIM
®
. For long-term
protection against hepatitis A virus a
booster vaccination with an
inactivated hepatitis A vaccine will
be required 6 to 36 months after
vaccination with VIVAXIM
®
. The
body does not develop long-term
protection against typhoid fever and
repeat vaccinations are required to
maintain protection.
Most people will produce enough
antibodies against typhoid fever and
hepatitis A infection. However, as
with all vaccines, 100% protection
cannot be guaranteed.
The vaccine will not give you
Typhoid fever or hepatitis A
infection.
The chance of a severe reaction from
VIVAXIM
®
 is very small, but the
risks from not being vac

Карактеристике производа

sanofi pasteur 
VIVAXIM (_Salmonella typhi_ Vi polysaccharide & inactivated hepatitis A virus vaccine) 

PAGE 1 OF 11 
AUSTRALIAN PRODUCT INFORMATION 

NAME OF THE MEDICINE 

VIVAXIM
®

_Salmonella typhi_ Vi polysaccharide and inactivated hepatitis A
virus antigen vaccine. 

DESCRIPTION 

VIVAXIM contains a sterile suspension of purified _Salmonella typhi _Vi polysaccharide 
and  formaldehyde  inactivated  hepatitis  A  virus  antigen  (GBM  strain)  adsorbed  onto 
aluminium hydroxide. VIVAXIM is presented in a dual-chamber by-pass syringe. The 
contents of both chambers are mixed immediately prior to injection by slowly pressing 
the plunger. 

Each 1 millilitre dose of mixed vaccine contains: 
ACTIVE INGREDIENTS: 
_Salmonella typhi _Vi polysaccharide (Ty 2 strain) 
25 μg 
Hepatitis A virus antigen*  
160 ELISA units** 

*  GBM strain cultured on MRC-5 human diploid cells. MRC-5 is a cell line that was 
derived from human embryonic lung tissue in the 1960s.  
** In  the  absence  of  an  international  standardised  reference,  the  antigen  content  is 
expressed using an in-house reference. 
OTHER COMPONENTS: 
_Salmonella typhi _Vi polysaccharide typhoid vaccine components: 
Phosphate buffer solution containing: 
Sodium chloride  
4.150 mg 
Sodium phosphate – dibasic dihydrate 
0.065 mg 
Sodium phosphate – monobasic  
0.023 mg 
Water for injections 
up to 0.5 mL 

Inactivated hepatitis A virus vaccine component: 
Aluminum hydroxide (quantity expressed as aluminium)  
0.3 mg 
Phenoxyethanol (preservative) 
2.5 µL 
Formaldehyde (preservative) 
12.5 µg 

Medium 199 (Hanks)*  
up to 0.5 mL 
*  Supplemented  with  polysorbate  80.  Medium  199  (Hanks)  without  phenol  red,  is  a 
complex  mixture  of  amino  acids  including  phenylalanine,  mineral