STAMARIL PASTEUR

البلد: أندونيسيا

اللغة: الإندونيسية

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

العنصر النشط:

LIVE ATTENUATED YELLOW FEVER VIRUS (17D-204 STRAIN)

متاح من:

AVENTIS PHARMA - Indonesia

INN (الاسم الدولي):

LIVE ATTENUATED YELLOW FEVER VIRUS (17D-204 STRAIN)

جرعة:

NLT 1000 IU

الشكل الصيدلاني:

SERBUK INJEKSI LIOFILISASI + PELARUT

الوحدات في الحزمة:

DUS, 1 VIAL @ 1 DOSIS + 1 PREFILLED SYRINGE PELARUT @ 0,5 ML

المصنعة من قبل:

SANOFI PASTEUR - France

تاريخ الترخيص:

2019-11-29

خصائص المنتج

STAMARIL PASTEUR
ATTENUATED YELLOW FEVER VACCINE
NAME OF THE MEDICINAL PRODUCT
STAMARIL PASTEUR, powder and solvent for suspension for injection in
multidose container Yellow
fever vaccine (Live)
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, 1 dose (0.5 ml) contains:
Yellow fever virus
1
17 D-204 strain (live, attenuated)not less than 1000 LD
50
units
2
1
produced in specified pathogen-free chick embryos
2
The statistically determined lethal dose in 50% of animals tested
For a full list of excipients, see section LIST OF EXCIPIENTS.
PHARMACEUTICAL FORM
Powder and solvent for suspension for injection.
Before reconstitution, the powder is homogeneous beige to orange
beige; the solvent is a limpid
solution.
THERAPEUTIC INDICATIONS
STAMARIL PASTEUR is a powder with solvent for single-dose suspension
for injection (0.5 mL). This
medicine is indicated in the prevention of yellow fever for travelers
to area where there is a persisting
or periodical risk of yellow fever transmission. Yellow fever
vaccination should not be prescribed for
individuals who are not risk of exposure to infection.
POSOLOGY AND METHOD OF ADMINISTRATION
_POSOLOGY _
Primary vaccination
The vaccine should be given at least 10 days before entering an
endemic area since protective
immunity may not be achieved until at least this time has elapsed.
Adults and children aged 9 months and over: A single dose of 0.5 ml of
reconstituted vaccine.
Re-vaccination:
The duration of protection is expected to be at least 10 years and may
be a life-long protection.
In accordance with WHO recommendations, the validity of a certificate
of vaccination against yellow
fever shall extend for the life of the person vaccinated.
However, re-vaccination may be needed in some individuals who had an
insufficient immune
response after their primary vaccination if they continue to be at
risk for yellow fever virus infection,
or in certain travellers to high risk areas of yellow fever virus
infection.
_METHOD OF ADMINISTRATION _
It is preferable that the vaccine