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

mylan health pty ltd - influenza virus haemagglutinin -

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

seqirus pty ltd - influenza virus haemagglutinin -

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

seqirus pty ltd - influenza virus haemagglutinin -

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

seqirus pty ltd - influenza virus haemagglutinin -

European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - split influenza virus, inactivated, containing antigen*: a/california/7/2009 (h1n1)v like strain (x-179a)*propagated in eggs. - influenza, human; immunization; disease outbreaks - influenza vaccines - prophylaxis of influenza in an officially declared pandemic situation. pandemic influenza vaccine should be used in accordance with official guidance

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

biocsl pty ltd. - influenza a virus a/california/7/2009 x-181 (h1n1) antigen (propiolactone inactivated) (unii: bh0r06yxfz) (influenza a virus a/california/7/2009 x-181 (h1n1) hemagglutinin antigen (propiolactone inactivated) - unii:mhg4xw7big), influenza a virus a/south australia/55/2014 ivr-175 (h3n2) antigen (propiolactone inactivated) (unii: 5087bpo79o) (influenza a virus a/south australia/55/2014 ivr-175 (h3n2) hemagglutinin antigen (propiolactone inactivated) - unii:9a68j3t9te), influenza b virus b/phuket/3073/2013 ant - influenza a virus a/california/7/2009 x-181 (h1n1) hemagglutinin antigen (propiolactone inactivated) 15 ug in 0.5 ml - afluria® is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes a and type b present in the vaccine. afluria is approved for use in persons 5 years of age and older. afluria 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 category b: a reproductive and developmental toxicity study has been performed in female rats at a dose approximately 265 times the human dose (on a mg/kg basis) and revealed no evidence of impaired female fertility or harm to the fetus due to afluria. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, afluria should be given to a pregnant woman only if clearly needed. in the reproductive and developmental toxicity study, the effect

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

seqirus pty ltd - influenza virus haemagglutinin, quantity: 30 microgram/ml - injection, suspension - excipient ingredients: sodium chloride; potassium chloride; monobasic potassium phosphate; dibasic sodium phosphate dihydrate; magnesium chloride hexahydrate; calcium chloride dihydrate; squalene; polysorbate 80; sorbitan trioleate; sodium citrate dihydrate; citric acid monohydrate; water for injections - active immunisation against influenza in the elderly (65 years of age and older), especially for those with an increased risk of associated complications (i.e. patients affected by underlying chronic diseases including diabetes, cardiovascular and respiratory diseases).

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

seqirus pty ltd - influenza virus haemagglutinin, quantity: 30 microgram/ml - injection, suspension - excipient ingredients: sodium chloride; potassium chloride; monobasic potassium phosphate; dibasic sodium phosphate dihydrate; magnesium chloride hexahydrate; calcium chloride dihydrate; squalene; polysorbate 80; sorbitan trioleate; sodium citrate dihydrate; citric acid monohydrate; water for injections - active immunisation against influenza in the elderly (65 years of age and older), especially for those with an increased risk of associated complications (i.e. patients affected by underlying chronic diseases including diabetes, cardiovascular and respiratory diseases).

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/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.