Bandaríkin - enska - 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.

Bandaríkin - enska - NLM (National Library of Medicine)

seqirus inc. - influenza a virus a/washington/19/2020 (h1n1) antigen (mdck cell derived, propiolactone inactivated) (unii: 3yn85tu9mj) (influenza a virus a/washington/19/2020 (h1n1) hemagglutinin antigen (mdck cell derived, propiolactone inactivated) - unii:32ss7wu2j7), influenza a virus a/tasmania/503/2020 (h3n2) antigen (mdck cell derived, propiolactone inactivated) (unii: 6er9j3gb63) (influenza a virus a/tasmania/503/2020 (h3n2) hemagglutinin antigen (mdck cell derived, propiolactone inactivated) - unii:bun3xfj2b3), - flucelvax quadrivalent is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes a and types b contained in the vaccine. flucelvax quadrivalent is approved for use in persons 6 months of age and older. [see clinical studies (14)] do not administer flucelvax quadrivalent to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine [see description (11)] . 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. there are insufficient data for flucelvax quadrivalent in pregnant women to inform vaccine-associated risks in pregnancy. there were no developmental toxicity studies of flucelvax quadrivalent performed in animals. a developmental toxicity study has been performed in female r

Bandaríkin - enska - NLM (National Library of Medicine)

seqirus inc. - influenza a virus a/georgia/12/2022 cvr-167 (h1n1) antigen (mdck cell derived, propiolactone inactivated) (unii: b8p3xn76w4) (influenza a virus a/georgia/12/2022 cvr-167 (h1n1) hemagglutinin antigen (mdck cell derived, propiolactone inactivated) - unii:n8jks3vk2a), influenza a virus a/darwin/11/2021 (h3n2) antigen (mdck cell derived, propiolactone inactivated) (unii: pv9k2r8hrm) (influenza a virus a/darwin/11/2021 (h3n2) hemagglutinin antigen (mdck cell derived, propiolactone inactivated) - unii:c6pm4nxj3 - flucelvax quadrivalent is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes a and types b contained in the vaccine. flucelvax quadrivalent is approved for use in persons 6 months of age and older. [see clinical studies (14)] do not administer flucelvax quadrivalent to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine [see description (11)] . 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% to 4% and 15% to 20%, respectively. data collected in a prospective pregnancy exposure registry from 665 women vaccinated with flucelvax quadrivalent showed no evidence of a vaccine-associated increase in the risk of major birth defects and miscarriages when flucelvax quadrivalent is administered during any trime

Bandaríkin - enska - 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)].

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

seqirus pty ltd - influenza virus haemagglutinin -

Evrópusambandið - enska - EMA (European Medicines Agency)

astrazeneca ab - reassortant influenza virus (live attenuated) of the following strain: a/vietnam/1203/2004 (h5n1) strain - influenza, human - vaccines - prophylaxis of influenza in an officially declared pandemic situation in children and adolescents from 12 months to less than 18 years of age.pandemic influenza vaccine h5n1 astrazeneca should be used in accordance with official guidance

Írland - enska - HPRA (Health Products Regulatory Authority)

intervet ireland limited - inactivated bovine respiratory syncytial virus strain ev908; inactivated parainfluenza-3-virus, strain sf-4 reisinger; inactivated mannheimia (pasteurella) haemolyticaa1, strain m4/1 - suspension for injection - . - bovine parainfluenza virus + bovine respiratory syncytial virus + pasteurella - cattle - immunological - inactivated vaccine

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

seqirus pty ltd - influenza virus haemagglutinin, quantity: 30 microgram/ml - injection, suspension - excipient ingredients: dibasic sodium phosphate; water for injections; monobasic potassium phosphate; sodium chloride; potassium chloride; calcium chloride dihydrate; monobasic sodium phosphate - for active immunization against influenza disease caused by influenza a subtype viruses and type b viruses contained in the vaccine.

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - influenza virus haemagglutinin, quantity: 15 microgram - injection, suspension - excipient ingredients: dl-alpha-tocopheryl acid succinate; potassium chloride; sodium chloride; water for injections; polysorbate 80; dibasic sodium phosphate dodecahydrate; magnesium chloride hexahydrate; octoxinol 10; monobasic potassium phosphate - fluarix tetra is a quadrivalent vaccine indicated for active immunisation of adults and children from 6 months of age for the prevention of influenza disease caused by the influenza virus types a and b contained in the vaccine (see section 5.1 pharmacodynamic properties, clinical trials).,the use of fluarix tetra should be based on official recommendations.

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - influenza virus haemagglutinin, quantity: 3.75 microgram - injection, suspension - excipient ingredients: water for injections; polysorbate 80; magnesium chloride hexahydrate; sodium chloride; thiomersal; potassium chloride; dibasic sodium phosphate dodecahydrate; octoxinol 10; monobasic potassium phosphate - prophylaxis of influenza in an officially declared pandemic situation. pandemrix h5n1 should be used in accordance with official recommendations.