European Union - English - EMA (European Medicines Agency)

seqirus gmbh - influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains:a/california/7/2009 (h1n1)pdm09 - like strain(a/brisbane/10/2010, wild type)a/switzerland/9715293/2013 (h3n2) - like strain(a/south australia/55/2014, wild type)b/phuket/3073/2013–like strain(b/utah/9/2014, wild type) - influenza, human; immunization - vaccines - prophylaxis of influenza for adults, especially in those who run an increased risk of associated complications.optaflu should be used in accordance to official guidance.

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/kansas/14/2017 x-327 (h3n2) antigen (formaldehyde inactivated) (unii: 3nzw5nd3d6) (influenza a virus a/kansas/14/2017 x-327 (h3n2) hemagglutinin antigen (formaldehyde inactivated) - unii:k329ycd1n9), influenza b virus b/maryland/15/2016 bx-69a antigen (formaldeh - influenza a virus a/michigan/45/2015 x-275 (h1n1) hemagglutinin antigen (formaldehyde inactivated) 60 ug in 0.5 ml - 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. 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. 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 bee

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

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

glaxosmithkline australia pty ltd - tetanus toxoid, quantity: 40 microgram/ml; haemophilus influenza type b polyribose ribitol phosphate, quantity: 20 microgram/ml - injection, powder for - excipient ingredients: water for injections; sodium chloride; lactose - hiberix is indicated for active immunisation against haemophilus influenzae type b infection in children aged from 2 months to 5 years.

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: 15 microgram - injection, suspension - excipient ingredients: sodium chloride; water for injections; potassium chloride; monobasic potassium phosphate; dibasic sodium phosphate dihydrate - vaxigrip tetra is indicated for the prevention of influenza disease caused by the two influenza a virus subtypes and the two influenza b virus types contained in the vaccine for:,- active immunisation of adults, including pregnant women, and children from 6 months of age and older,- passive protection of infant(s) from birth to less than 6 months of age following vaccination of pregnant women (see sections 4.2 dose and method of administration, 4.4 special warnings and precautions for use, 4.6 fertility, pregnancy and lactation and 5.1 pharmacodynamic properties ? clinical trials).

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

sanofi-aventis australia pty ltd - influenza virus haemagglutinin, quantity: 15 microgram - injection, suspension - excipient ingredients: sodium chloride; water for injections; potassium chloride; monobasic potassium phosphate; dibasic sodium phosphate dihydrate - vaxigrip tetra is indicated for the prevention of influenza disease caused by the two influenza a virus subtypes and the two influenza b virus types contained in the vaccine for:,- active immunisation of adults, including pregnant women, and children from 6 months of age and older,- passive protection of infant(s) from birth to less than 6 months of age following vaccination of pregnant women (see sections 4.2 dose and method of administration, 4.4 special warnings and precautions for use, 4.6 fertility, pregnancy and lactation and 5.1 pharmacodynamic properties ? clinical trials).

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

seqirus pty ltd - influenza virus haemagglutinin, quantity: 15 microgram - injection, suspension - excipient ingredients: monobasic potassium phosphate; magnesium chloride hexahydrate; sorbitan trioleate; squalene; sodium citrate dihydrate; citric acid monohydrate; calcium chloride dihydrate; potassium chloride; water for injections; sodium chloride; dibasic sodium phosphate dihydrate; polysorbate 80 - active immunisation against influenza in persons 65 years of age and older.

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

seqirus pty ltd - influenza virus haemagglutinin, quantity: 15 microgram - injection, suspension - excipient ingredients: monobasic potassium phosphate; magnesium chloride hexahydrate; sorbitan trioleate; squalene; sodium citrate dihydrate; citric acid monohydrate; calcium chloride dihydrate; potassium chloride; water for injections; sodium chloride; dibasic sodium phosphate dihydrate; polysorbate 80 - active immunisation against influenza in persons 65 years of age and older.