Australia - English - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - influenza virus haemagglutinin, quantity: 60 microgram - injection, suspension - excipient ingredients: octoxinol 9; monobasic sodium phosphate; water for injections; dibasic sodium phosphate; sodium chloride - fluzone high-dose quadrivalent (qiv) is indicated for active immunisation for the prevention of influenza disease. fluzone high-dose quadrivalent is indicated for use in persons 60 years of age and older., the use of fluzone high-dose quadrivalent (qiv) should be based on official recommendations., see section 5.1 clinical trials for information on the effects on influenza associated complications.

United States - English - 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/phuket/3073/2013 antigen (formaldehy - fluzone® high-dose quadrivalent is a vaccine indicated for active immunization for the prevention of influenza caused by influenza a subtype viruses and type b viruses contained in the vaccine. fluzone high-dose quadrivalent is indicated for use in persons 65 years of age and older. a 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 is a contraindication to administration of fluzone high-dose quadrivalent. fluzone high-dose quadrivalent is not approved for use in persons <65 years of age. there are limited human data on fluzone high-dose and no animal data available on fluzone high-dose quadrivalent to establish whether there is a vaccine-associated risk with use of fluzone high-dose quadrivalent in pregnancy. fluzone high-dose quadrivalent 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 quadrivalent on

United States - English - 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/california/122/2022 san-022 (h3n2) antigen (formaldehyde inactivated) (unii: n7cb2u8hac) (influenza a virus a/california/122/2022 san-022 (h3n2) hemagglutinin antigen (formaldehyde inactivated) - unii:8l9r8s52vv), influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated) (unii: ff9yp4d23c) (influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated) - unii:ff9yp4d23c), influenza b virus b/phuket/3073/2013 antigen (formaldehyde inactivated) (unii: b93bqx9789) (influenza b virus b/phuket/3073/2013 hemagglutinin antigen (formaldehyde inactivated) - unii:9hb0xus9tm) - fluzone® quadrivalent southern hemisphere is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza a subtype viruses and type b viruses contained in the vaccine. fluzone quadrivalent southern hemisphere is approved for use in persons 6 months of age and older. do not administer fluzone quadrivalent southern hemisphere to anyone with a history of a 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 quadrivalent southern hemisphere and fluzone quadrivalent are manufactured using the same process. data in this section were obtained in studies with fluzone quadrivalent. pregnancy exposure registry sanofi pasteur inc. is maintaining a prospective pregnancy exposure registry to collect data on pregnancy outcomes following vaccination with fluzone quadrivalent during pregnancy. healthcare providers are encouraged to enroll women who receive fluzone quadrivalent during pregnancy in sanofi pasteur inc.'s vaccination pregnancy registry by calling 1-800-822-2463. 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 quadrivalent use in pregnant women are insufficient to inform vaccine-associated risk of adverse developmental outcomes. a developmental and reproductive toxicity study was performed in female rabbits given a 0.5 ml/dose of fluzone quadrivalent prior to mating and during gestation (a single human dose is 0.5 ml). this study revealed no adverse effects to the fetus or pre-weaning development due to fluzone quadrivalent [see animal data (8.1)] . data animal data: in a developmental and reproductive toxicity study female rabbits were administered a 0.5 ml/dose of fluzone quadrivalent by intramuscular injection 24 and 10 days before insemination, and on days 6, 12, and 27 of gestation (a single human dose is 0.5 ml). there were no adverse effects on pre-weaning development or vaccine-related fetal malformations noted in this study. 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. risk summary it is not known whether fluzone quadrivalent is excreted in human milk. data are not available to assess the effects of fluzone quadrivalent 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 quadrivalent and any potential adverse effects on the breastfed child from fluzone quadrivalent 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 quadrivalent southern hemisphere in children below the age of 6 months have not been established. safety and immunogenicity of fluzone quadrivalent were evaluated in adults 65 years of age and older. [see clinical studies (14.6).] antibody responses to fluzone quadrivalent are lower in persons ≥65 years of age than in younger adults.

United States - English - 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/california/122/2022 san-022 (h3n2) antigen (formaldehyde inactivated) (unii: n7cb2u8hac) (influenza a virus a/california/122/2022 san-022 (h3n2) hemagglutinin antigen (formaldehyde inactivated) - unii:8l9r8s52vv), influenza b virus b/phuket/3073/2013 antigen (formaldehyde inactivated) (unii: b93bqx9789) (influenza b virus b/phuket/3073/2013 hemagglutinin antigen (formaldehyde inactivated) - unii:9hb0xus9tm), 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 quadrivalent southern hemisphere is a vaccine indicated for active immunization for the prevention of influenza caused by influenza a subtype viruses and type b viruses contained in the vaccine. fluzone high-dose quadrivalent southern hemisphere is indicated for use in persons 65 years of age and older. a 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 is a contraindication to administration of fluzone high-dose quadrivalent southern hemisphere. fluzone high-dose quadrivalent southern hemisphere and fluzone high-dose quadrivalent are manufactured using the same process. data in this section were obtained in studies with fluzone high-dose quadrivalent. fluzone high-dose quadrivalent southern hemisphere is not approved for use in persons <65 years of age. there are limited human data on fluzone high-dose and no animal data available on fluzone high-dose quadrivalent southern hemisphere to establish whether there is a vaccine-associated risk with use of fluzone high-dose quadrivalent in pregnancy. fluzone high-dose quadrivalent southern hemisphere 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 quadrivalent southern hemisphere on the breastfed infant or on milk production/excretion. safety and effectiveness of fluzone high-dose quadrivalent southern hemisphere in children younger than 18 years of age have not been established. safety, immunogenicity, and efficacy of fluzone high-dose quadrivalent have been evaluated in adults 65 years of age and older [see adverse reactions (6.1) and clinical studies (14)].

Australia - English - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - influenza virus haemagglutinin -

United States - English - NLM (National Library of Medicine)

sanofi pasteur inc. - influenza a virus a/brisbane/02/2018 ivr-190 (h1n1) antigen (formaldehyde inactivated) (unii: xw4jb03ti5) (influenza a virus a/brisbane/02/2018 ivr-190 (h1n1) hemagglutinin antigen (formaldehyde inactivated) - unii:92xe6ghc89), influenza a virus a/kansas/14/2017 x-327 (h3n2) antigen (formaldehyde inactivated) (unii: 3nzw5nd3d6) (influenza a virus a/kansas/14/2017 x-327 (h3n2) hemagglutinin antigen (formaldehyde inactivated) - unii:k329ycd1n9), influenza b virus b/maryland/15/2016 bx-69a antigen (formaldeh - influenza a virus a/michigan/45/2015 x-275 (h1n1) hemagglutinin antigen (formaldehyde inactivated) 60 ug in 0.5 ml - 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. a 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 is a contraindication to administration of fluzone high-dose. 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 bee

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

sanofi-aventis south africa (pty) ltd - injection - each 0,5 ml solution contains influenza virus a/beijing/535/95 (h1n1) 15,0 ug influenza virus a/sydney/5/97-like (h3n2) 15,0 ug influenza virus b/yamanashi/166/98 15,0 ug

United States - English - NLM (National Library of Medicine)

sanofi pasteur inc. - influenza a virus a/victoria/2570/2019 ivr-215 (h1n1) antigen (formaldehyde inactivated) (unii: wd5e5vym2e) (influenza a virus a/victoria/2570/2019 ivr-215 (h1n1) hemagglutinin antigen (formaldehyde inactivated) - unii:erb9sj9vmq), 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/phuket/3073/2013 antigen (formaldehy - influenza a virus a/michigan/45/2015 x-275 (h1n1) hemagglutinin antigen (formaldehyde inactivated) 15 ug in 0.5 ml - fluzone® quadrivalent is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza a subtype viruses and type b viruses contained in the vaccine. fluzone quadrivalent is approved for use in persons 6 months of age and older. do not administer fluzone quadrivalent to anyone with a history of a 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 sanofi pasteur inc. is maintaining a prospective pregnancy exposure registry to collect data on pregnancy outcomes following vaccination with fluzone quadrivalent during pregnancy. healthcare providers are encouraged to enroll women who receive fluzone quadrivalent during pregnancy in sanofi pasteur inc.'s vaccination pregnancy registry by calling 1-800-822-2463. risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. general popul

United States - English - NLM (National Library of Medicine)

sanofi pasteur inc. - influenza a virus a/brisbane/02/2018 ivr-190 (h1n1) antigen (formaldehyde inactivated) (unii: xw4jb03ti5) (influenza a virus a/brisbane/02/2018 ivr-190 (h1n1) hemagglutinin antigen (formaldehyde inactivated) - unii:92xe6ghc89), influenza a virus a/south australia/34/2019 ivr-197 (h3n2) antigen (formaldehyde inactivated) (unii: 9g0xu62hkp) (influenza a virus a/south australia/34/2019 ivr-197 (h3n2) hemagglutinin antigen (formaldehyde inactivated) - unii:nd5y3fdi9p), influenza b virus b/phuket/3073/2013 ant - fluzone® quadrivalent southern hemisphere is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza a subtype viruses and type b viruses contained in the vaccine. fluzone quadrivalent southern hemisphere is approved for use in persons 6 months of age and older. do not administer fluzone quadrivalent southern hemisphere to anyone with a history of a 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 quadrivalent southern hemisphere and fluzone quadrivalent are manufactured using the same process. data in this section were obtained in studies with fluzone quadrivalent. pregnancy exposure registry sanofi pasteur inc. is maintaining a prospective pregnancy exposure registry to collect data on pregnancy outcomes following vaccination with fluzone quadrivalent during pregnancy. healthcare providers are encouraged to enroll women who rece

Australia - English - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - influenza virus haemagglutinin, quantity: 15 microgram - injection, suspension - excipient ingredients: sodium chloride; monobasic sodium phosphate; octoxinol 9; dibasic sodium phosphate - fluquadri is indicated for active immunisation of influenza disease caused by influenza a subtype viruses and type b viruses contained in the vaccine.,fluquadri is indicated for use in adults and children 6 months and older.