STAMARIL PASTEUR

国: インドネシア

言語: インドネシア語

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

有効成分:

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

から入手可能:

AVENTIS PHARMA - Indonesia

INN（国際名）:

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

投薬量:

NLT 1000 IU

医薬品形態:

SERBUK INJEKSI LIOFILISASI + PELARUT

パッケージ内のユニット:

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

製:

SANOFI PASTEUR - France

承認日:

2019-11-29

製品の特徴

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