爱尔兰 - 英文 - HPRA (Health Products Regulatory Authority)

sanofi pasteur msd ltd - a/singapore /6/86 (h1n1)-like strain a/wuhan /359/95 (h3n2)-like strain b/beijing /184/93-like strain - solution for injection

新加坡 - 英文 - HSA (Health Sciences Authority)

pfizer private limited - crm197 protein; pneumococcal polysaccharide serotype 1 (conjugate); pneumococcal polysaccharide serotype 14 (conjugate); pneumococcal polysaccharide serotype 18c (conjugate); pneumococcal polysaccharide serotype 19a (conjugate); pneumococcal polysaccharide serotype 19f (conjugate); pneumococcal polysaccharide serotype 23f (conjugate); pneumococcal polysaccharide serotype 3 (conjugate); pneumococcal polysaccharide serotype 4 (conjugate); pneumococcal polysaccharide serotype 5 (conjugate); pneumococcal polysaccharide serotype 6a (conjugate); pneumococcal polysaccharide serotype 6b (conjugate); pneumococcal polysaccharide serotype 7f (conjugate); pneumococcal polysaccharide serotype 9v (conjugate) - injection, suspension - 32mcg - crm197 protein 32mcg; pneumococcal polysaccharide serotype 1 (conjugate) 2.2mcg; pneumococcal polysaccharide serotype 14 (conjugate) 2.2mcg; pneumococcal polysaccharide serotype 18c (conjugate) 2.2mcg; pneumococcal polysaccharide serotype 19a (conjugate) 2.2mcg; pneumococcal polysaccharide serotype 19f (conjugate) 2.2mcg; pneumococcal polysaccharide serotype 23f (conjugate) 2.2mcg; pneumococcal polysaccharide serotype 3 (conjugate) 2.2mcg; pneumococcal polysaccharide serotype 4 (conjugate) 2.2mcg; pneumococcal polysaccharide serotype 5 (conjugate) 2.2mcg; pneumococcal polysaccharide serotype 6a (conjugate) 2.2mcg; pneumococcal polysaccharide serotype 6b (conjugate) 4.4mcg; pneumococcal polysaccharide serotype 7f (conjugate) 2.2mcg; pneumococcal polysaccharide serotype 9v (conjugate) 2.2mcg

美国 - 英文 - NLM (National Library of Medicine)

sanofi pasteur inc. - influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) antigen (formaldehyde inactivated) (unii: au5c98u4bb) (influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) hemagglutinin antigen (formaldehyde inactivated) - unii:c46xjt9fq9), influenza a virus a/darwin/9/2021 san-010 (h3n2) antigen (formaldehyde inactivated) (unii: kja387fhb2) (influenza a virus a/darwin/9/2021 san-010 (h3n2) hemagglutinin antigen (formaldehyde inactivated) - unii:6s4y8a8uey), influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated) (unii: ff9yp4d23c) (influenza b virus b/michigan/01/2021 hemagglutinin antigen (formaldehyde inactivated) - unii:cqv855h5fg) - fluzone® is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza a subtype viruses and type b virus contained in the vaccine. fluzone is approved for use in persons 6 months of age and older. do not administer fluzone to anyone with a history of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine [see description (11)], including egg protein, or to a previous dose of any influenza vaccine. pregnancy exposure registry there is a prospective pregnancy exposure registry that monitors pregnancy outcomes in women exposed to fluzone. healthcare providers are encouraged to enroll women who receive fluzone during pregnancy in sanofi pasteur inc.'s vaccination pregnancy registry at sanofipasteurpregnancyregistry.com or by calling 1-800-822-2463 (1-800-vaccine). risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. available data with fluzone use in pregnant women are insufficient to inform vaccine-associated risk of adverse developmental outcomes. there were no developmental studies of fluzone performed in animals. the developmental effects of fluzone quadrivalent are relevant to fluzone because both vaccines are manufactured using the same process and have overlapping compositions. a developmental toxicity study was performed in female rabbits administered fluzone quadrivalent prior to mating and during gestation. the dose was 0.5 ml on each of five occasions (a single human dose is 0.5 ml). this study revealed no adverse effects to the fetus or pre-weaning development and no evidence of impaired female fertility due to fluzone quadrivalent (see data). data animal data: a developmental toxicity study was performed in female rabbits administered fluzone quadrivalent by intramuscular injection on 24 and 10 days before insemination, and on days 6, 12, and 27 of gestation. the dose was 0.5 ml on each occasion (a single human dose is 0.5 ml). this study revealed no vaccine related fetal malformations and no adverse effects on pre-weaning development or female fertility. clinical considerations disease-associated maternal and/or embryo/fetal risk pregnant women are at increased risk of complications associated with influenza infection compared to non-pregnant women. pregnant women who contract influenza may be at increased risk for adverse pregnancy outcomes, including preterm labor and delivery. it is not known if fluzone is excreted in human milk. data are not available to assess the effects of fluzone on the breastfed infant or on milk production/excretion. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for fluzone and any potential adverse effects on the breastfed child from fluzone or from the underlying maternal condition. for preventive vaccines, the underlying maternal condition is susceptibility to the disease prevented by the vaccine. safety and effectiveness of fluzone in children below the age of 6 months have not been established. safety and effectiveness of fluzone in children 9 through 17 years of age is based on safety and effectiveness in children 6 months through 8 years of age and adults 18 years of age and older. safety and immunogenicity of fluzone were evaluated in adults 65 years of age and older. [see adverse reactions (6.1) and clinical studies (14.3) ] antibody responses to fluzone are lower in persons ≥65 years of age than in younger adults. [see clinical studies (14.5, 14.6) ]

新西兰 - 英文 - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - influenza virus a/michigan/45/2015 (h1n1) pdm09 - like strain 60ug (a/michigan/45/2015, x-275); influenza virus a/singapore/infimh-16-0019/2016 (h3n2) - like strain 60ug (a/singapore/infimh-16-0019/2016, nib-104); influenza virus b/phuket/3073/2013 - like strain 60ug (b/phuket/3073/2013 (yamagata lineage)) - suspension for injection - 180 mcg/dose - active: influenza virus a/michigan/45/2015 (h1n1) pdm09 - like strain 60ug (a/michigan/45/2015, x-275) influenza virus a/singapore/infimh-16-0019/2016 (h3n2) - like strain 60ug (a/singapore/infimh-16-0019/2016, nib-104) influenza virus b/phuket/3073/2013 - like strain 60ug (b/phuket/3073/2013 (yamagata lineage)) excipient: dibasic sodium phosphate monobasic sodium phosphate octoxinol 9 sodium chloride water for injection - for active immunisation against influenza disease caused by influenza virus subtypes a and type b contained in the vaccine for use in persons 65 years of age and older.

阿拉伯联合酋长国 - 英文 - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

pharmatrade united states of america - 10 single-dose pre-filled syringes (0.7 ml) - injection - 60 µg/60 µg/60 µg/60 µg/pre-filled syringe - immunologicals , vaccines-vaccines , antisera

阿拉伯联合酋长国 - 英文 - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

pharmatrade united states of america - 10 single-dose pre-filled syringes (0.7 ml) - injection - 60 µg/60 µg/60 µg/60 µg/pre-filled syringe - immunologicals , vaccines-vaccines , antisera

美国 - 英文 - NLM (National Library of Medicine)

sanofi pasteur inc. - influenza a virus a/michigan/45/2015 x-275 (h1n1) antigen (formaldehyde inactivated) (unii: 8ksk0802bp) (influenza a virus a/michigan/45/2015 x-275 (h1n1) hemagglutinin antigen (formaldehyde inactivated) - unii:116749898h) - influenza a virus a/michigan/45/2015 x-275 (h1n1) hemagglutinin antigen (formaldehyde inactivated) 9 ug in 0.1 ml

美国 - 英文 - NLM (National Library of Medicine)

sanofi pasteur inc. - influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) antigen (formaldehyde inactivated) (unii: au5c98u4bb) (influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) hemagglutinin antigen (formaldehyde inactivated) - unii:c46xjt9fq9), influenza a virus a/darwin/9/2021 san-010 (h3n2) antigen (formaldehyde inactivated) (unii: kja387fhb2) (influenza a virus a/darwin/9/2021 san-010 (h3n2) hemagglutinin antigen (formaldehyde inactivated) - unii:6s4y8a8uey), influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated) (unii: ff9yp4d23c) (influenza b virus b/michigan/01/2021 hemagglutinin antigen (formaldehyde inactivated) - unii:cqv855h5fg) - fluzone® high-dose is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza a subtype viruses and type b virus contained in the vaccine. fluzone high-dose is approved for use in persons 65 years of age and older. do not administer fluzone high-dose to anyone with a history of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine [see description (11) ], including egg protein, or to a previous dose of any influenza vaccine. fluzone high-dose is not approved for use in persons <65 years of age. there are limited human data and no animal data available to establish whether there is a vaccine-associated risk with use of fluzone high-dose in pregnancy. fluzone high-dose is not approved for use in persons <65 years of age. no human or animal data are available to assess the effects of fluzone high-dose on the breastfed infant or on milk production/excretion. safety and effectiveness of fluzone high-dose in persons <65 years of age have not been established. safety, immunogenicity, and efficacy of fluzone high-dose have been evaluated in adults 65 years of age and older. [see adverse reactions (6.1) and clinical studies (14) ]

新西兰 - 英文 - Medsafe (Medicines Safety Authority)

seqirus (nz) ltd - influenza virus a/johannesburg/33/94 15ug (1996 season); influenza virus a/texas/36/91 h1n1 15ug (1996 season); influenza virus b/harbin/7/94 15ug - solution for injection - 15µg ha/0.5ml - active: influenza virus a/johannesburg/33/94 15ug (1996 season) influenza virus a/texas/36/91 h1n1 15ug (1996 season) influenza virus b/harbin/7/94 15ug excipient: gelatin thiomersal

加拿大 - 英文 - Health Canada

sanofi pasteur limited - haemagglutinin-strain a (h1n1); haemagglutinin-strain a (h3n2); haemagglutinin-strain b (victoria); haemagglutinin-strain b (yamagata) - suspension - 7.5mcg; 7.5mcg; 7.5mcg; 7.5mcg - haemagglutinin-strain a (h1n1) 7.5mcg; haemagglutinin-strain a (h3n2) 7.5mcg; haemagglutinin-strain b (victoria) 7.5mcg; haemagglutinin-strain b (yamagata) 7.5mcg - vaccines