IMOJEV

국가: 인도네시아

언어: 인도네시아어

출처: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

유효 성분:

LIVE ATTENUATED 17D STRAIN OF YELLOW FEVER VIRUS

제공처:

AVENTIS PHARMA - Indonesia

INN (International Name):

LIVE ATTENUATED 17D STRAIN OF YELLOW FEVER VIRUS

복용량:

4,0-5,8 LOG PFU

약제 형태:

SERBUK INJEKSI

패키지 단위:

DUS, 10 VIAL @ 4 DOSIS @ 0,5 ML + 10 VIAL PELARUT @ 2 ML

Manufactured by:

GOVERNMENT PHARMACEUTICAL ORGANIZATION - MERIEUX BIOLOGICAL PRODUCTS - Thailand

승인 날짜:

2018-09-24

제품 특성 요약

KSF/XXXXXX
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IMOJEV®
POWDER AND DILUENT* FOR SUSPENSION FOR INJECTION
JAPANESE ENCEPHALITIS VACCINE (LIVE, ATTENUATED)
* 0.4% Sterile Sodium chloride solution (IMOJEV®)
* 0.9% Sterile Sodium chloride solution (IMOJEV®Multidose)
COMPOSITION
After reconstitution, one dose (0.5 mL) contains:
Live, attenuated, recombinant Japanese encephalitis virus*: 4.0 - 5.8
log PFU**
* Propagated in Vero cells
** Plaque Forming Unit
LIST OF EXCIPIENTS
Powder
Mannitol, Lactose monohydrate, Glutamic acid, Potassium hydroxide,
Histidine, Human
Serum Albumin
Diluent
Sodium chloride, Water for injections
No adjuvant or antimicrobial preservative is added
PHARMACEUTICAL FORM
Powder and diluent for suspension for injection
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.
THERAPEUTIC INDICATION
Imojev is indicated for prophylaxis of Japanese encephalitis caused by
the Japanese encepha-
litis virus, in subjects from 9 months of age and over.
POSOLOGY AND ADMINISTRATION
Posology
Primary Vaccination:
Subjects 9 months of age and over one 0.5 mL single injection of the
reconstituted vaccine.
Booster
- Paediatric population
Paediatric population (up to 18 years of age):
If a long term protection* is required, one 0.5 mL dose of IMOJEV®
should be given as a
booster dose after primary vaccination. The booster dose should be
given preferably 12
months
after
primary
vaccination
and
can
be
given
up
to
24
months
after
primary
vaccination.
One 0.5 mL dose of Imojev can also be given as a booster vaccination
in children who were
previously given an inactivated Japanese encephalitis vaccine for
primary vaccination, in
accordance with the recommended timing for the booster of the
inactivated Japanese
encephalitis vaccine.
*Immunity is maintained at a high level at least 4 years after the
booster dose when the vaccine
used for primary vaccination is JE-CV (Imojev).
- Adult populatio