VAXIGRIP

Country: ইন্দোনেশিয়া

ভাষা: ইন্দোনেশীয়

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

সক্রিয় উপাদান:

INFLUENSAVACCIN

থেকে পাওয়া:

BIO FARMA - Indonesia

INN (International Name):

INFLUENSAVACCIN

ফার্মাসিউটিকাল ফর্ম:

CAIRAN INJEKSI

প্যাকেজ ইউনিট:

DUS, 1 PRE-FILLED SYRINGE @ 0,5 ML (1 DOSIS)

Manufactured by:

SANOFI PASTEUR - France

অনুমোদন তারিখ:

2018-10-17

পণ্য বৈশিষ্ট্য

VAXIGRIP
®
2018/2019 STRAINS
INACTIVATED INFLUENZA VACCINE
(SPLIT VIRION)
1. QUALITATIVE AND QUANTITATIVE COMPOSITION
The active substance is influenza virus*, split, inactivated, I dose
containing antigens
equivalent to:
ADULTS
-A/Michigan/45/2015 (HINI)pdm09-like virus………………15 µg
HA**
-A/
Singapore/INFIMH-16-0019/2016 (H3N2)-like virus…..15 µg HA**
-B/Colorado/06/2017-like virus……………………………….15
µg HA**
For one 0.5 mL dose
PEDIATRIC USE
- A/Michigan/45/2015 (HINI) pdm09-like virus…………… 7.5 µg
HA**
-A/
Singapore/INFIMH-16-0019/2016 (H3N2)-like virus…7.5 µg HA**
-B/Colorado/06/2017-like virus……………………………..7.5
µg HA**
For one 0.25 mL dose
*
propagated in eggs
**
hemagglutinin
The vaccine complies with the WHO recommendation (northern hemisphere)
for the
2018-2019 season.
VAXIGRIP may contain traces of eggs, such as ovalbumin, and of
neomycin,
formaldehyde and octoxinol- 9, which are used during the manufacturing
process
2. PHARMACEUTICAL FORM
Suspension for injection in prefilled syringe.
The vaccine, after shaking gently, is a slightly whitish and
opalescent liquid.
3. CLINICAL PARTICULARS
3.1. THERAPEUTIC INDICATIONS
VAXIGRIP
®
is a suspension for injection in prefilled syringe of 0.5 ml in box of
1 or vial
5 mL VAXIGRIP
®
, pediatric use, is a suspension for injection in a prefilled syringe
of
0.25 mL in box of 1. This vaccine is recommended for the prevention of
influenza, in
adults and in children aged from 6 to 35 months (pediatric use),
particularly in subjects
showing a high risk of associated complications.
3.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
Adult and children from 36 months: one 0.5 mL dose.
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DISETUJUI OLEH BPOM 07/04/2020
ID REG EREG10040911900184-7
Children from 6 to 35 months: 0.25 mL dose.
For children who have not previously been vaccinated, a second dose
should be given
after an interval of at least 4 weeks.
METHOD OF ADMINISTRATION:
Intramuscular route, or deep subcutaneous injection.
The vac