Krajina: Indonézia
Jazyk: indonézština
Zdroj: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
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
BIO FARMA - Indonesia
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
15 Mcg /15 Mcg /15 Mcg
SUSPENSI INJEKSI
DUS, 1 PREFILLED SYRINGE @ 0,5 ML (1 DOSIS)
HUALAN BIOLOGICAL BACTERIN CO., LTD. - China
2020-07-08
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 Prečítajte si celý dokument