IMOJEV japanese encephalitis vaccine (live, attenuated) powder for injection vial plus diluent vial

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

active_ingredient:

Japanese encephalitis virus, Quantity: 4 PFU

MAH:

Biocelect Pty Ltd

INN:

Japanese encephalitis virus

pharmaceutical_form:

Injection, powder for

composition:

Excipient Ingredients: Albumin; mannitol; glutamic acid; histidine; sodium chloride; potassium hydroxide; lactose monohydrate; water for injections

administration_route:

Subcutaneous

units_in_package:

1 powder vial and 1 diluent vial, 1 syringe and 2 needles

prescription_type:

(S4) Prescription Only Medicine

therapeutic_indication:

IMOJEV is indicated for prophylaxis of Japanese encephalitis caused by the Japanese encephalitis virus, in individuals from 9 months of age and over.

leaflet_short:

Visual Identification: A white to creamy white homogeneous cake which might be retracted.; Container Type: Multiple containers; Container Material: Glass Type I Clear; Container Life Time: 48 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

authorization_status:

Registered

authorization_date:

2010-08-23

PIL

IMOJEV®
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING IMOJEV?
Imojev contains the active ingredient Japanese encephalitis virus
(live, attenuated). Imojev is used to help to protect you or your
child against Japanese encephalitis.
For more information, see Section 1. Why am I using Imojev? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE IMOJEV?
Do not use if you have ever had an allergic reaction to Imojev or any
of the ingredients listed at the end of the CMI
Talk to your doctor if you have any other medical conditions, take any
other medicines, or are pregnant or plan to become pregnant
or are breastfeeding.
For more information, see Section 2. What should I know before I use
Imojev? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Imojev and affect how it works. Tell
your doctor, nurse or pharmacist if you are taking, have
recently taken or might take any other vaccines or medicines,
including medicines obtained without a prescription.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE IMOJEV?
Imojev is given by your doctor, nurse or pharmacist.
More instructions can be found in Section 4. How do I use Imojev? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING IMOJEV?
THINGS YOU
SHOULD DO
Tell your doctor, nurse or pharmacist before you receive the vaccine:
•
If you or your child is allergic to the active ingredients, or any of
the ingredients listed at the end of this
leaflet. Always check the ingredients to make sure you or your child
can use this medicine.
•
If you or your child has an illness with febrile or acute disease. The
vaccination should be postponed until
after you or your child has recovered,
•
If you or your child has lowered immunity due to treatment with
medicines such as corticosteroids or
other medicines used to treat ca

SPC

.
imoj-ccdsv10-piv5-18mar20
Page 1 of 21
AUSTRALIAN PRODUCT INFORMATION – IMOJEV (JAPANESE
ENCEPHALITIS VIRUS (LIVE, ATTENUATED)
1
NAME OF THE MEDICINE
Japanese encephalitis virus (live, attenuated)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
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 (JE) virus. These
are the premembrane (prM) and envelope (E) coding sequences of the
SA14-14-2 live
attenuated JE 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
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Powder for injection and diluent.
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.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Imojev
is
indicated
for
prophylaxis
of
Japanese
encephalitis
caused
by
the
Japanese
encephalitis virus, in individuals from 9 months of age and over.
4.2
DOSE AND METHOD OF ADMINISTRATION
_PRIMARY VACCINATION: _
Individuals 9 months of age and over: a 0.5 mL single injection of the
reconstituted vaccine.
_ _
.
imoj-ccdsv10-piv5-18mar20
Page 2 of 21
_BOOSTER: _
•
Adult population (18 years of age and over)
There is no need for a booster dose up to 5 years after the
administration of a single dose of
Imojev.
•
Paediatric population (9 months to 17 years of age inclusive)
A booster dose of Imojev should be given after primary vaccination in
order to confer long
term protection. The booster dose should be given preferably 12 months
after primary
vaccination and can be