FLUBIO HL

국가: 인도네시아

언어: 인도네시아어

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

유효 성분:

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

제공처:

BIO FARMA - Indonesia

INN (국제 이름):

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

복용량:

15 Mcg /15 Mcg /15 Mcg

약제 형태:

SUSPENSI INJEKSI

패키지 단위:

DUS, 1 PREFILLED SYRINGE @ 0,5 ML (1 DOSIS)

Manufactured by:

HUALAN BIOLOGICAL BACTERIN CO., LTD. - China

승인 날짜:

2020-07-08

제품 특성 요약

FLUBIO HL
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 strai
ns 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 curre
nt year. The vaccine 0.5 mL contains:
A/GUANGDONG‐MAONAN/SWL1536/2019 (H1N1)PDM09‐LIKE VIRUS
(A/GUANGDONG‐MAONAN/SWL1536/2019, CNIC‐1909)
15μɡ hemagglutinin
A/HONG KONG/2671/2019 (H3N2) ‐LIKE VIRUS (A/HONG KONG/2671/2019,
NIB‐121)
15μɡ hemagglutinin
B/WASHINGTON/02/2019 ‐ LIKE VIRUS (B/WASHINGTON/02/2019, WILD TYPE)
15μɡ hemagglutinin
Excipients:
Sodium Chloride
4250μg
Sodium Dihydrogen Phosphate 137μg
Disodium Hydrogen Phosphate
547μg
[Indication]
It is indicated for active immunization againts influenza disease
caused by influenza virus subtypes A an
d typ
e B contained in the
vaccine for prophylaxis of the influenza caused by the contained
vaccine strain. The vaccine is approved for use in vulnerable
people and high risk population for influenza complication, such as
children over 3 years of age, the elderly, the weak and people
in infl
uenza epidemic areas.
[Specifications]
This vaccine per single human dose is 0.5 mL in pre filled syringe
containing not lower than 15µg HA for each virus strain.
[Posology]
Intramuscularly inject the vaccine in the region of the deltoid muscle
of the upper arm. Persons 3 years of age and ol
der should
vaccinate with a single dose of 0.5 ml before or during the flu
epidemic season.
[Adverse Reactions]
As with all other