Stati Uniti - Ingliż - 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.

Stati Uniti - Ingliż - 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)].

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

rr55 pty ltd t/a tempt vip - 45138 - basic male condom, hevea-latex - reduce the risk of pregnancy and/or the transmission of hiv/aids and other sexually transmitted disease and infections.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

fitzone solutions pty ltd - 47103 - hyperthermia device, insect bite/sting - the insect bite healer is intended for relieving itching and swelling caused by insect bites or stings by applying heat (local hyperthermia)

New Zealand - Ingliż - Medsafe (Medicines Safety Authority)

seqirus (nz) ltd - influenza virus a (h1n1) haemagglutinin 15ug (a/victoria/4897/2022 (h1n1)pdm09-like virus (a/victoria/4897/2022 (ivr-238))); influenza virus a (h3n2) haemagglutinin 15ug (a/thailand/8/2022 (h3n2)-like virus (a/thailand/8/2022 (ivr-237))); influenza virus b (victoria) haemagglutinin 15ug (b/austria/1359417/2021(b/victoria lineage)-like virus (b/austria/1359417/2021 (bvr-26))); influenza virus b (yamagata) haemagglutinin 15ug (b/phuket/3073/2013-like virus (b/phuket/3073/2013 (bvr-1b))) - suspension for injection - 60 mcg/0.5ml - active: influenza virus a (h1n1) haemagglutinin 15ug (a/victoria/4897/2022 (h1n1)pdm09-like virus (a/victoria/4897/2022 (ivr-238))) influenza virus a (h3n2) haemagglutinin 15ug (a/thailand/8/2022 (h3n2)-like virus (a/thailand/8/2022 (ivr-237))) influenza virus b (victoria) haemagglutinin 15ug (b/austria/1359417/2021(b/victoria lineage)-like virus (b/austria/1359417/2021 (bvr-26))) influenza virus b (yamagata) haemagglutinin 15ug (b/phuket/3073/2013-like virus (b/phuket/3073/2013 (bvr-1b))) excipient: calcium chloride dihydrate dibasic sodium phosphate monobasic potassium phosphate monobasic sodium phosphate potassium chloride sodium chloride water for injection - for the prevention of influenza caused by influenza virus, types a and b contained in the vaccine. afluria quad vaccine is indicated for use in persons aged 3 years and over. for full details regarding recommendations for influenza vaccination, please refer to the relevant national immunisation guidelines.

Stati Uniti - Ingliż - 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) ]

Stati Uniti - Ingliż - 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) ]

Stati Uniti - Ingliż - NLM (National Library of Medicine)

seqirus pty ltd. - influenza a virus a/brisbane/02/2018 ivr-190 (h1n1) antigen (propiolactone inactivated) (unii: 0qk4u2v88l) (influenza a virus a/brisbane/02/2018 ivr-190 (h1n1) hemagglutinin antigen (propiolactone inactivated) - unii:re1mnp1ne6), influenza a virus a/kansas/14/2017 x-327 (h3n2) antigen (propiolactone inactivated) (unii: al8g7d406d) (influenza a virus a/kansas/14/2017 x-327 (h3n2) hemagglutinin antigen (propiolactone inactivated) - unii:mu3in5k1yc), influenza b virus b/maryland/15/2016 antigen (propiolacto - afluria® quadrivalent is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza a subtype viruses and type b viruses contained in the vaccine. afluria quadrivalent is approved for use in persons 6 months of age and older. afluria quadrivalent is contraindicated in individuals with known severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine (see description [11]) . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to afluria quadrivalent during pregnancy. women who are vaccinated with afluria quadrivalent during pregnancy are encouraged to enroll in the registry by calling 1-855-358-8966 or sending an email to seqirus at us.medicalinformation@seqirus.com. risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated ba

Stati Uniti - Ingliż - NLM (National Library of Medicine)

seqirus pty ltd. - influenza a virus a/victoria/2454/2019 ivr-207 (h1n1) antigen (propiolactone inactivated) (unii: ytl6a60f5i) (influenza a virus a/victoria/2454/2019 ivr-207 (h1n1) hemagglutinin antigen (propiolactone inactivated) - unii:540gm6ll7u), influenza a virus a/hong kong/2671/2019 ivr-208 (h3n2) antigen (propiolactone inactivated) (unii: oat4h11zt6) (influenza a virus a/hong kong/2671/2019 ivr-208 (h3n2) hemagglutinin antigen (propiolactone inactivated) - unii:pc99fhq5w6), influenza b virus b/victoria/705/2018 bv - afluria® quadrivalent is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza a subtype viruses and type b viruses contained in the vaccine. afluria quadrivalent is approved for use in persons 6 months of age and older. afluria quadrivalent is contraindicated in individuals with known severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine (see description [11]) . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to afluria quadrivalent during pregnancy. women who are vaccinated with afluria quadrivalent during pregnancy are encouraged to enroll in the registry by calling 1-855-358-8966 or sending an email to seqirus at us.medicalinformation@seqirus.com. risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated ba

Stati Uniti - Ingliż - NLM (National Library of Medicine)

seqirus pty ltd. - influenza a virus a/victoria/2570/2019 ivr-215 (h1n1) antigen (propiolactone inactivated) (unii: 6f59dl4eet) (influenza a virus a/victoria/2570/2019 ivr-215 (h1n1) hemagglutinin antigen (propiolactone inactivated) - unii:qwb7m7p3k9), influenza a virus a/cambodia/e0826360/2020 ivr-224 (h3n2) antigen (propiolactone inactivated) (unii: y9cjf75rbv) (influenza a virus a/cambodia/e0826360/2020 ivr-224 (h3n2) hemagglutinin antigen (propiolactone inactivated) - unii:lw2jc76p6m), influenza b virus b/victoria/705/2 - afluria® quadrivalent is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza a subtype viruses and type b viruses contained in the vaccine. afluria quadrivalent is approved for use in persons 6 months of age and older. afluria quadrivalent is contraindicated in individuals with known severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine (see description [11] ) . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to afluria quadrivalent during pregnancy. women who are vaccinated with afluria quadrivalent during pregnancy are encouraged to enroll in the registry by calling 1-855-358-8966 or sending an email to seqirus at us.medicalinformation@seqirus.com . risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated