מדינה: אינדונזיה
שפה: אינדונזית
מקור: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
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
BIO FARMA - Indonesia
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
7.5 Mcg /7.5 Mcg /7.5 MCG
SUSPENSI INJEKSI
DUS, 1 PREFILLED SYRINGE @ 0,25 ML (1 DOSIS)
HUALAN BIOLOGICAL BACTERIN CO., LTD. - China
2020-07-08
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 קרא את המסמך השלם