Imojev

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

Japanese encephalitis virus

Beschikbaar vanaf:

Sanofi-Aventis Australia Pty Ltd

klasse:

Medicine Registered

Bijsluiter

IMOJEV
®

_Japanese encephalitis vaccine (live, attenuated)_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU OR YOUR CHILD IS
VACCINATED.
KEEP THIS LEAFLET. YOU MAY NEED TO
READ IT AGAIN.
If you have any further questions, ask
your doctor or pharmacist.
This vaccine has been prescribed for
you or your child. Do not pass it on
to others.
IF ANY OF THE SIDE EFFECTS GETS
SERIOUS, OR IF YOU NOTICE ANY SIDE
EFFECTS NOT LISTED IN THIS LEAFLET,
PLEASE TELL YOUR DOCTOR OR
PHARMACIST.
IN THIS LEAFLET:
•
What IMOJEV
®
 is and what it is
used for
•
Before you or your child is given
IMOJEV
®
•
How IMOJEV
®
 is given
•
Possible side effects
•
Storing IMOJEV
®
•
Further information.
WHAT IMOJEV
®
 IS AND
WHAT IT IS USED FOR
IMOJEV
®
 is a vaccine that helps to
protect you or your child against
Japanese encephalitis.
The vaccine may be administered to
persons of 12 months of age and
over.
When an injection of IMOJEV
®
 is
given, the immune system (body's
natural defences) will protect against
Japanese encephalitis infection.
However, as with all vaccines, 100%
protection cannot be guaranteed.
In adults, IMOJEV
®
 will generally
begin protecting against Japanese
encephalitis 2 weeks after the
injection.
In children, IMOJEV
®
 will generally
begin protecting against Japanese
encephalitis 4 weeks after the
injection.
IMOJEV
®
 will not prevent Japanese
encephalitis if you or your child is
incubating the disease before
vaccination or if the encephalitis is
caused by another virus.
BEFORE YOU OR YOUR
CHILD IS GIVEN
IMOJEV
®
_WHO SHOULD NOT RECEIVE_
_IMOJEV_
_®_
•
If you or your child is allergic
(hypersensitive) to the active
substance or any of the other
ingredients of IMOJEV
®
 listed in
the 'Further Information' section
•
If you or your child has an illness
with febrile or acute infection.
The vaccination should be
postponed until after you or your
child has recovered
•
If you or your child has lowered
immunity due to treat

Productkenmerken

SANOFI PASTEUR 
AUSTRALIAN PI, V 1.1 
JE-CV 

PAGE 1 OF 14 
AUSTRALIAN PRODUCT INFORMATION 
NAME OF THE MEDICINE 
IMOJEV
®

Japanese encephalitis vaccine (live, attenuated) 
DESCRIPTION 
IMOJEV
®
 is a monovalent, live attenuated viral vaccine. The virus was
obtained via recombinant 
DNA technology. It is based on the 17D-204 yellow fever vaccine
virus in which two genes have 
been replaced by the corresponding genes from
Japanese encephalitis virus. These are the 
premembrane (prM) and envelope (E) coding sequences of
the SA14-14-2 live attenuated 
Japanese encephalitis vaccine
virus. The immunising antigens are the prM and E proteins from
the 
SA14-14-2 vaccine virus. 
_ _
AFTER RECONSTITUTION: 
ACTIVE INGREDIENTS: 
Live, attenuated, recombinant Japanese encephalitis virus*:
4.0 - 5.8 log PFU** 
* Propagated in Vero cells 
** Plaque Forming Unit 
EXCIPIENTS: 

  Mannitol 

  Lactose 

  Glutamic acid 

  Potassium hydroxide 

  Histidine 

  Human Serum Albumin 

  Sodium chloride 

  Water for injections 
No adjuvant or antimicrobial preservative is added. 
The powder is a white to creamy white homogeneous cake which
might be retracted from the 
sides of the vial. The diluent is a clear
solution. After reconstitution, IMOJEV
®
 is a colourless to 
amber suspension. 
SANOFI PASTEUR 
AUSTRALIAN PI, V 1.1 
JE-CV 

PAGE 2 OF 14 
PHARMACOLOGY 
MECHANISM OF ACTION 
The vaccine is a live attenuated virus. Following administration,
the virus replicates locally and 
elicits neutralising antibodies and cell-mediated
immune responses that are specific to the 
Japanese encephalitis virus. Available results indicate that
protection is mainly mediated by 
neutralising antibodies. 
In nonclinical studies, all animals that received a single dose of
the vaccine developed specific 
neutralising antibodies against Japanese enceph