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

sanofi-aventis australia pty ltd - rabies immunoglobulin, quantity: 150 iu/ml - injection - excipient ingredients: glycine; sodium chloride; water for injections - imogam rabies pasteurized is indicated in subjects who are thought to have been exposed to rabies virus, especially cases of major exposure, in accordance with w.h.o. recommendations as specified in the international product information.

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

sanofi pasteur inc. - influenza a virus a/wisconsin/588/2019 (h1n1) recombinant hemagglutinin antigen (unii: gb6adz2asn) (influenza a virus a/wisconsin/588/2019 (h1n1) recombinant hemagglutinin antigen - unii:gb6adz2asn), influenza a virus a/darwin/6/2021 (h3n2) recombinant hemagglutinin antigen (unii: 7vj7x8pkx3) (influenza a virus a/darwin/6/2021 (h3n2) recombinant hemagglutinin antigen - unii:7vj7x8pkx3), influenza b virus b/austria/1359417/2021 recombinant hemagglutinin antigen (unii: m48387n67g) (influenza b virus b/aust - flublok quadrivalent is a vaccine indicated for active immunization against disease caused by influenza a subtype viruses and type b viruses contained in the vaccine. flublok quadrivalent is approved for use in persons 18 years of age and older [see clinical studies (14)] . flublok quadrivalent is contraindicated in individuals with known severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine [see postmarketing experience (6.2) and description (11)] . pregnancy exposure pregnancy outcomes in women who have been exposed to flublok quadrivalent during pregnancy are being monitored. sanofi pasteur inc. is maintaining a prospective pregnancy exposure registry to collect data on pregnancy outcomes and newborn health status following vaccination with flublok quadrivalent during pregnancy. healthcare providers are encouraged to enroll women who receive flublok quadrivalent during pregnancy in sanofi pasteur inc.'s vaccination pregnancy registry by calling 1-800-822-2463. risk summary all pre

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/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

Singapore - English - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - diphtheria toxoid protein; meningococcal (serogroup a) polysaccharide (monovalent conjugate); meningococcal (serogroup c) polysaccharide (monovalent conjugate); meningococcal (serogroup w-135) polysaccharide (monovalent conjugate); meningococcal (serogroup y) polysaccharide (monovalent conjugate) - injection, solution - 48 microgram (diptheria toxoid quantity is approximate and dependent on the conjugate polysaccharide to protein ratio) - diphtheria toxoid protein 48 mcg/dose (0.5 ml) (diphtheria toxoid quantity is approximate and dependent on the conjugate polysaccharide to protein ratio); meningococcal (serogroup a) polysaccharide (monovalent conjugate) 4 mcg/dose (0.5 ml); meningococcal (serogroup c) polysaccharide (monovalent conjugate) 4 mcg/dose (0.5 ml); meningococcal (serogroup w-135) polysaccharide (monovalent conjugate) 4 mcg/dose (0.5 ml); meningococcal (serogroup y) polysaccharide (monovalent conjugate) 4 mcg/dose (0.5 ml)

Singapore - English - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - meningococcal polysaccharide vaccine groups a, c, y, w-135 - injection, powder, for solution - 50 mcg/ps/0.5 ml - meningococcal polysaccharide vaccine groups a, c, y, w-135 50 mcg/ps/0.5 ml

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

sanofi pasteur inc. - influenza a virus a/california/7/2009(h1n1)-like antigen (formaldehyde inactivated) (unii: 5i5hvc73i8) (influenza a virus a/california/7/2009(h1n1)-like hemagglutinin antigen (formaldehyde inactivated) - unii:euj84un96z) - influenza a virus a/california/7/2009(h1n1)-like hemagglutinin antigen (formaldehyde inactivated) 15 ug in 0.5 ml - influenza a (h1n1) 2009 monovalent vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons 6 months of age and older against influenza disease caused by pandemic (h1n1) 2009 virus. do not administer influenza a (h1n1) 2009 monovalent vaccine to anyone with a known severe hypersensitivity to egg proteins or any component of the vaccine or life-threatening reactions after previous administration of any influenza vaccine. [see warnings and precautions (5) and description (11) ] sanofi pasteur's influenza a (h1n1) 2009 monovalent vaccine and seasonal trivalent influenza virus vaccine (fluzone vaccine) are manufactured by the same process. available information for fluzone vaccine is provided in this section. pregnancy category c: animal reproduction studies have not been conducted with influenza a (h1n1) 2009 monovalent vaccine or fluzone vaccine. it is also not known whether these vaccines can cause fetal harm when administered to a pregnant woman or can affect reproduction

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

sanofi pasteur inc. - neisseria meningitidis group a capsular polysaccharide diphtheria toxoid conjugate antigen (unii: re9a0h8oab) (neisseria meningitidis group a capsular polysaccharide diphtheria toxoid conjugate antigen - unii:re9a0h8oab), neisseria meningitidis group c capsular polysaccharide diphtheria toxoid conjugate antigen (unii: 2j57k2523t) (neisseria meningitidis group c capsular polysaccharide diphtheria toxoid conjugate antigen - unii:2j57k2523t), neisseria meningitidis group y capsular polysaccharide diphtheria - neisseria meningitidis group a capsular polysaccharide diphtheria toxoid conjugate antigen 4 ug in 0.5 ml - menactra® , meningococcal (groups a, c, y and w-135) polysaccharide diphtheria toxoid conjugate vaccine, is indicated for active immunization to prevent invasive meningococcal disease caused by neisseria meningitidis serogroups a, c, y and w-135. menactra is approved for use in individuals 9 months through 55 years of age. menactra does not prevent n meningitidis serogroup b disease. severe allergic reaction (eg, anaphylaxis) after a previous dose of a meningococcal capsular polysaccharide-, diphtheria toxoid- or crm197 -containing vaccine, or to any component of menactra [see description (11) ]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to menactra during pregnancy. to enroll in or obtain information about the registry, call sanofi pasteur at 1-800-822-2463. risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the us general population, the estimated background risk of major birth defects an

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

sanofi pasteur inc. - neisseria meningitidis group a capsular polysaccharide tetanus toxoid conjugate antigen (unii: t4gyx3110d) (neisseria meningitidis group a capsular polysaccharide tetanus toxoid conjugate antigen - unii:t4gyx3110d), neisseria meningitidis group c capsular polysaccharide tetanus toxoid conjugate antigen (unii: zt89e5a103) (neisseria meningitidis group c capsular polysaccharide tetanus toxoid conjugate antigen - unii:zt89e5a103), neisseria meningitidis group y capsular polysaccharide tetanus toxoid conjugate antigen (unii: 4wan8pqk15) (neisseria meningitidis group y capsular polysaccharide tetanus toxoid conjugate antigen - unii:4wan8pqk15), neisseria meningitidis group w-135 capsular polysaccharide tetanus toxoid conjugate antigen (unii: l77ok410kw) (neisseria meningitidis group w-135 capsular polysaccharide tetanus toxoid conjugate antigen - unii:l77ok410kw) - menquadfi® is a vaccine indicated for active immunization for the prevention of invasive meningococcal disease caused by neisseria meningitidis serogroups a, c, w, and y. menquadfi is indicated for use in individuals 2 years of age and older. menquadfi does not prevent n. meningitidis serogroup b disease. severe allergic reaction to any component of the vaccine, or after a previous dose of menquadfi or any other tetanus toxoid-containing vaccine [see description (11) ]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to menquadfi during pregnancy. to enroll in or obtain information about the registry, call sanofi pasteur at 1-800-822-2463. risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the us general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. there are no clinical studies of menquadfi in pregnant women. available human data on menquadfi administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. a developmental toxicity study in female rabbits administered a full human dose (0.5 ml) prior to mating and during gestation period revealed no evidence of harm to the fetus due to menquadfi (see animal data ). data animal data in a developmental toxicity study, female rabbits received a human dose of menquadfi by intramuscular injection on five occasions: 30 days and 10 days prior to mating, gestation days 6, 12 and 27. no adverse effects on pre-weaning development up to post-natal day 35 were observed. there were no vaccine-related fetal malformations or variations observed. risk summary it is not known whether menquadfi is excreted in human milk. data are not available to assess the effects of menquadfi 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 menquadfi and any potential adverse effects on the breastfed child from menquadfi or from the underlying maternal condition. for preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine. safety and effectiveness of menquadfi have not been established in individuals younger than 2 years of age in the us. a total of 249 participants 65 years of age and older, including 71 participants 75 years of age or older, in study 4 received one dose of menquadfi [see adverse reactions (6.1) and clinical studies (14.1) ]. menquadfi recipients ≥ 65 years of age had lower gmts and seroresponse rates for all serogroups compared to menquadfi recipients 56 through 64 years of age [see clinical studies (14.1) ].