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/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.

Ireland - English - HPRA (Health Products Regulatory Authority)

sanofi pasteur msd ltd - tetanus toxoid, diphtheria toxoid, pertussis toxoid, filamentous haemagglutinin (fha), pertactin, polio virus type 1 inactivated, polio virus type 2 inactivated, polio virus type 3 inactivated, adsorbed fimbriae types 2 + 3 - suspension for injection - unknown - bacterial and viral vaccines, combined

Ireland - English - HPRA (Health Products Regulatory Authority)

sanofi pasteur msd ltd - tetanus toxoid, diphtheria toxoid, pertussis toxoid, filamentous haemagglutinin, pertactin, fimbriae types 2 and 3, adsorbed aluminium phosphate - suspension for injection - pertussis, purified antigen, combinations with toxoids

Ireland - English - HPRA (Health Products Regulatory Authority)

sanofi pasteur - purified diphtheria toxoid ph. eur.; purified tetanus toxoid; adsorbed purified pertussis toxoid; adsorbed purified filamentous haemagglutinin; inactivated poliomyelitis virus ph. eur; inactivated type 1 poliovirus; inactivated type 2 poliovirus; inactivated type 3 poliovirus; haemophilus influenzae type b, conjugate with tetanus protein - powder for suspension for injection - 0.5 millilitre(s) - diphtheria-hemophilus influenzae b-pertussis-poliomyelitis-tetanus

Malta - English - Medicines Authority

sanofi pasteur 14 espace henry vallée , 69007 lyon, france - diphtheria toxoid, tetanus toxoid - suspension for injection - diphtheria toxoid tetanus toxoid - vaccines

Ireland - English - HPRA (Health Products Regulatory Authority)

sanofi pasteur - tetanus toxoid, diphtheria toxoid, pertussis toxoid, filamentous haemagglutinin, pertactin, fimbriae types 2 and 3, adsorbed aluminium phosphate - suspension for injection - unknown - pertussis, purified antigen, combinations with toxoids

Ireland - English - HPRA (Health Products Regulatory Authority)

sanofi pasteur - diphtheria toxoid; tetanus toxoid; pertussis toxoid; filamentous haemagglutinin; pertactin (prn); fimbriae types 2 and 3 - suspension for injection in pre-filled syringe - 0 international unit(s) - pertussis vaccines; pertussis, purified antigen, combinations with toxoids

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

Ireland - English - HPRA (Health Products Regulatory Authority)

sanofi pasteur - tetanus toxoid; diphtheria toxoid; pertussis toxoid; filamentous haemagglutinin (fha); pertactin; polio virus type 1 inactivated; polio virus type 2 inactivated; polio virus type 3 inactivated; adsorbed aluminium phosphate; adsorbed fimbriae types 2 + 3 - suspension for injection in pre-filled syringe - 0.5 millilitre(s) - bacterial and viral vaccines, combined; diphtheria-pertussis-poliomyelitis-tetanus