FLUBIO HL PEDIATRIC USE

Страна: Индонезия

Език: индонезийски

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

Активна съставка:

A/HONG KONG/4801/2014 (H3N2)-LIKE VIRUS, B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/07/2009(H1N1)PDM09-LIKE VIRUS

Предлага се от:

BIO FARMA - Indonesia

INN (Международно Name):

A/HONG KONG/4801/2014 (H3N2)-LIKE VIRUS, B/BRISBANE/60/2008-LIKE STRAIN (B/BRISBANE/60/2008, WILD TYPE), A/CALIFORNIA/07/2009(H1N1)PDM09-LIKE VIRUS

дозиране:

7.5 Mcg /7.5 Mcg /7.5 MCG

Лекарствена форма:

SUSPENSI INJEKSI

Броя в опаковка:

DUS, 1 PREFILLED SYRINGE @ 0,25 ML (1 DOSIS)

Произведено от:

HUALAN BIOLOGICAL BACTERIN CO., LTD. - China

Дата Оторизация:

2020-07-08

Данни за продукта

FLUBIO HL PEDIATRIC USE
PACKAGE INSERT OF INFLUENZA VACCINE (SPLIT VIRION), INACTIVATED
[DRUG NAME]
Generic Name: Influenza Vaccine (Split Virion), Inactivated
English Name: Influenza Vaccine (Split Virion), Inactivated
Chinese Pinyin: Liugan Bingdu Liejie Yimiao
[COMPOSITION]
The vaccine is prepared from influenza virus type A and B prevalent
strains recommended by WHO. The virus strains
are propagated in embryonated chicken eggs. After incubation ,the
virus suspensions in allantoic cavities are
harvested. The vaccine is prepared by inactivation, concentration,
purification and splitting. The vaccine is a slightly
opalescent liquid.
Dosage form: suspension for injection.
Active ingredients: Hemagglutinin of prevalent strains of influenza
virus in current year.
The vaccine 0.25 mL contains:
A/california/07/2009(H1N1)pdm09-like virus
7.5μɡ hemagglutinin
A/hong kong/4801/2014 (H3N2)-like virus
7.5μɡ hemagglutinin
B/brisbane/60/2008-like strain (B/brisbane/60/2008, wild type)
7.5μɡ hemagglutinin
Excipients:
Sodium Chloride
2125μg
Sodium Dihydrogen Phosphate
68μg
Disodium Hydrogen Phosphate
274μg
[INDICATION]
It is indicated for active immunization against influenza disease
caused by influenza virus subtypes A and type B
contained in the vaccine for prophylaxis of the influenza caused by
the contained vaccine strain. Children of 6 months
to 3 years.
[SPECIFICATIONS]
This vaccine per single human dose is 0.25 mL in pre filled syringe
containing not lower than 7.5 µg HA for each virus
strain.
[POSOLOGY]
Intramuscularly inject the vaccine in the region of the deltoid muscle
of the upper arm. Children of 6 months to 35
months shall be vaccinated two dose, each with 0.25 ml at least 2-4
weaks apart.
[ADVERSE REACTIONS]
1.
Redness, swelling, pain, tenderness and pruritus at the injection site
may appear in a few of subjects within
12-24 hours post-vaccination. Normally it will disappear soon, does
not affect normal activities.
2.
A few of subjects would appear muscle pain, joint pain, headache,
malaise, fever and