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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
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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been replaced by the corresponding genes from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
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