国: インドネシア
言語: インドネシア語
ソース: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
HAEMAGGLUTININ A/MICHIGAN/45/2015 X-275 (H1N1); HAEMAGGLUTININ B/BRISBANE/60/2008 (VICTORIA LINEAGE); HAEMAGGLUTININ B/PHUKET/3073/20-13 (YAMAGATA LINEAGE); HAEMAGLUTININ A/HONGKONG/4801/2014 X-263B (H3N2)
AVENTIS PHARMA - Indonesia
HAEMAGGLUTININ A/MICHIGAN/45/2015 X-275 (H1N1); HAEMAGGLUTININ B/BRISBANE/60/2008 (VICTORIA LINEAGE); HAEMAGGLUTININ B/PHUKET/3073/20-13 (YAMAGATA LINEAGE); HAEMAGLUTININ A/HONGKONG/4801/2014 X-263B (H3N2)
30 UG HA TOTAL PER 0.5 ML DOS
CAIRAN INJEKSI
DUS, 5 SYRINGE @ 0,5 mL (1 DOSIS)
SANOFI PASTEUR - USA
2017-05-15
FLUQUADRI SH Quadrivalent Influenza Vaccine Types A and B 2017 Formula FULL PRESCRIBING INFORMATION: INDICATION AND USAGE FluQuadri is an activated quadrivalent influenza vaccine indicated for the prevention of influenza disease caused by influenza types A and B viruses contained in the vaccine in children (6 months to 9 years old), adult with high risk factor (>18 years old), and elderly (>60 years old) COMPOSITION: Per 0.25 mL contains: Hemagglutinin A/Michigan/45/2015 X-275 (H1N1) 7.5 mcg, hemagglutinin A/Hongkong/4801/2014 X-263B (H3N2) 7.5 mcg. Hemagglutinin B/Phuket/3073/2013 (Yamagata lineage) 7.5 mcg, and hemagglutinin B/Brisbane/60/2008 (Victoria lineage) 7.5 mcg Per 0.5 mL contains: Hemagglutinin A/Michigan/45/2015 X-275 (H1N1) 15 mcg, hemagglutinin A/Hongkong/4801/2014 X-263B (H3N2) 15 mcg. Hemagglutinin B/Phuket/3073/2013 (Yamagata lineage) 15 mcg, and hemagglutinin B/Brisbane/60/2008 (Victoria lineage) 15 mcg The vaccine complies with the W.H.O. recommendations (Southern Hemisphere) for the 2017 season. DOSAGE AND ADMINISTRATION FOR INTRAMUSCULAR USE ONLY DOSE AND SCHEDULE The dose and schedule for FluQuadri are presented in Table 1. TABLE 1: DOSE AND SCHEDULE FOR FLUQUADRI Age Dose Schedule 6 months through 35 months One or two doses*, 0.25 mL each If 2 doses, administer at least 1 month apart 36 months through 8 years One or two doses*, 0.5 mL each If 2 doses, administer at least 1 month apart 9 years and older One dose, 0.5 mL - *1 or 2 dose depends on vaccination history and local or national recommendations “.” Indicates information is not applicable ADMINISTRATION Inspect FluQuadri visually for particulate matter and/or discoloration prior to administration. If either of these conditions exist, the vaccine should not be administered. Before administering a dose of vaccine, shake the prefilled syringe to uniformly distribute the suspension before administering each dose. Aseptic technique must be used. Use a separate, sterile syringe and needle, or a sterile disposable unit, for each individ 完全なドキュメントを読む