Vivotif

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

Salmonella typhi

Dostupno od:

CSL Limited

Razred:

Medicine Registered

Uputa o lijeku

VIVOTIF
®
 ORAL

_Oral Typhoid Vaccine_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Vivotif
®
 Oral.
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 or your
child having Vivotif
®
 Oral against
the benefits expected.
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 VIVOTIF
®
 ORAL IS
USED FOR
Vivotif
®
 Oral is a vaccine used to
prevent typhoid fever. Typhoid fever
is a severe form of infection caused
by a type of Salmonella bacteria.
Vaccination with Vivotif
®
 Oral is
recommended for adults and children
over 6 years of age who live in or
travel through areas where typhoid
fever occurs.
_HOW IT WORKS_
Vivotif
®
 Oral contains live bacteria
called Salmonella typhi strain Ty21a,
which do not cause typhoid fever.
Vivotif
®
 Oral works by causing your
body to produce its own protection
against the bacteria (germs) which
cause typhoid fever. The body makes
substances, called antibodies, which
destroy the Salmonella typhi
bacteria. If you have been vaccinated
against Salmonella typhi, your body
is able to attack the bacteria if you
come in contact with it.
Protection with Vivotif
®
 Oral
requires a full course of 3 doses.
After a full course most people will
produce enough antibodies to prevent
typhoid fever. However, as with all
vaccines, 100% protection cannot be
guaranteed.
The vaccine cannot give you or your
child typhoid fever.
The chance of a severe reaction from
Vivotif
®
 Oral is very small, but the
risks from not being vaccinated
against typhoid fever may be very
serious.
BEFORE YOU TAKE
VIVOTIF
®
 ORAL
_WHEN YOU OR YOUR CHILD_
_MUST NOT TAKE VIVOTIF_
_®_
_ ORAL_
DO NOT TAKE VIVOTIF
®
 ORAL IF YOU
HAVE AN ALLERGY TO:
•
Vivotif
®
 Oral or any of the
in

Svojstava lijeka

VIVOTIF
®
 ORAL 
Product Information  

Version 4.3 
AUST R 158130 
Page 1 of 5 

NAME OF THE MEDICINE  

Oral Typhoid Vaccine 

DESCRIPTION 

Vivotif Oral is an oral, live, attenuated typhoid vaccine for active
immunization against 
typhoid and contains _Salmonella typhi_ strain Ty21a.  Each enteric
coated capsule 
contains not fewer than 2 x 10
9
 viable organisms. Each capsule also contains the 
following excipients: ethylene glycol, sucrose, ascorbic acid,
protein hydrolysate, 
lactose, magnesium stearate, hydroxypropyl methylcellulose phthalate,
gelatin, 
titanium dioxide, erythrosine ci45430, iron oxide yellow ci77492, iron
oxide red 
ci77491, dibutyl phthalate, diethyl phthalate.  

PHARMACOLOGY  

The attenuated Ty21a strain is a mutant of _Salmonella typhi_, which
is deficient in the 
enzyme UDP-4-galactose epimerase.  This results in the organisms
being unable to 
effectively metabolize galactose.  When grown in the presence of
adequate amounts 
of galactose, the organism accumulates galactose-containing
metabolites and 
ultimately undergoes spontaneous lysis.  In the presence of a
restricted supply of 
galactose the organism develops the smooth lipopolysaccharide coat
believed to be 
necessary for immune response.  In the intestine, where galactose
is normally 
present, it is however unable to survive for long.  The vaccine
strain cannot be 
detected in the stools after 3 days following oral ingestion. 

CLINICAL TRIALS 

In one clinical study conducted in Egypt, in children above 6 years
of age, oral 
ingestion of the vaccine as a solution preceded by a dose of sodium
bicarbonate to 
reduce gastric activity (in order to reduce lysis of the organism in
the stomach), 
provided approximately 95% protection against typhoid.  In another
study, conducted 
in Chile, enteric coated capsules provided approximately 70%
protection.  The 
duration of protection conferred by Vivotif Oral remains to be fully
established.  
H