Unión Europea - inglés - EMA (European Medicines Agency)

novartis vaccines and diagnostics s.r.l. - influenza virus surface antigens (haemagglutinin and neuraminidase) of strain a/viet nam/1194/2004 (h5n1) - influenza, human, immunization, disease outbreaks - vaccines, - active immunisation against h5n1 subtype of influenza a virus., this indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing a/vietnam/1194/2004 (h5n1)-like strain., prepandemic influenza vaccine (h5n1) novartis vaccines and diagnostic should be used in accordance with official recommendations.,

Estados Unidos - inglés - 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

Estados Unidos - inglés - 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

Irlanda - inglés - HPRA (Health Products Regulatory Authority)

seqirus s.r.l. - a/guangdong-maonan/swl 1536/2019 (h1n1)pdm09-like strain (a/guangdong-maonan/swl 1536/2019, cnic-1909); a/hong kong/2671/2019 (h3n2)-like strain (a/hong kong/2671/2019, ivr-208); b/washington/02/2019-like strain (b/washington/02/2019, wild type) - suspension for injection in pre-filled syringe - . - influenza vaccines; influenza, inactivated, split virus or surface antigen - influenza vaccine - prophylaxis of influenza, especially in those who run an increased risk of associated complications

Estados Unidos - inglés - NLM (National Library of Medicine)

deseret biologicals, inc. - influenza a virus a/california/7/2009 x-179a (h1n1) antigen (formaldehyde inactivated) (unii: xqo8062u6r) (influenza a virus a/california/7/2009 x-179a (h1n1) hemagglutinin antigen (formaldehyde inactivated) - unii:c8e791ro82) - influenza a virus a/california/7/2009 x-179a (h1n1) hemagglutinin antigen (formaldehyde inactivated) 9 [hp_x] in 1 ml

Estados Unidos - inglés - 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

Canadá - inglés - Health Canada

id biomedical corporation of quebec - haemagglutinin from a/california/7/2009 (h1n1)v-like strain (x-179a) - suspension - 15mcg - haemagglutinin from a/california/7/2009 (h1n1)v-like strain (x-179a) 15mcg - vaccines

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

seqirus pty ltd - influenza virus haemagglutinin, quantity: 7.5 microgram - injection, suspension - excipient ingredients: sodium chloride; dibasic sodium phosphate; monobasic sodium phosphate; potassium chloride; monobasic potassium phosphate; calcium chloride dihydrate - for active immunisation to prevent influenza disease caused by the influenza a (h1n1) virus, in persons from 6 months of age.

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

seqirus pty ltd - influenza virus haemagglutinin, quantity: 15 microgram - injection, suspension - excipient ingredients: sodium chloride; dibasic sodium phosphate; monobasic sodium phosphate; potassium chloride; monobasic potassium phosphate; calcium chloride dihydrate; thiomersal - for active immunisation to prevent influenza disease caused by the influenza a (h1n1) virus, in persons from 6 months of age.

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

seqirus pty ltd - influenza virus haemagglutinin, quantity: 15 microgram - injection, suspension - excipient ingredients: sodium chloride; dibasic sodium phosphate; monobasic sodium phosphate; potassium chloride; monobasic potassium phosphate; calcium chloride dihydrate - for active immunisation to prevent influenza disease caused by the influenza a (h1n1) virus, in persons from 6 months of age.