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

New Zealand - English - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - influenza virus a/hong kong/4801/2014 (h3n2) - like strain 15ug (a/ hong kong/4801/2014 nymc x-263b );  ; influenza virus a/michigan/45/2015 (h1n1) pdm09 - like strain 15ug (a/michigan/45/2015 nymc x-275);  ; influenza virus b/brisbane/60/2008 - like strain 15ug (b/brisbane/60/2008 );   - solution for injection - 0.5 ml - active: influenza virus a/hong kong/4801/2014 (h3n2) - like strain 15ug (a/ hong kong/4801/2014 nymc x-263b )   influenza virus a/michigan/45/2015 (h1n1) pdm09 - like strain 15ug (a/michigan/45/2015 nymc x-275)   influenza virus b/brisbane/60/2008 - like strain 15ug (b/brisbane/60/2008 )   excipient: dibasic sodium phosphate dihydrate monobasic potassium phosphate neomycin potassium chloride sodium chloride water for injection - vaxigrip is indicated for the prevention of influenza caused by influenza virus types a and b in adults and children aged 6 months and over.

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

protein sciences corporation - influenza a virus a/michigan/45/2015 (h1n1) recombinant hemagglutinin antigen (unii: 69h0yj871t) (influenza a virus a/michigan/45/2015 (h1n1) recombinant hemagglutinin antigen - unii:69h0yj871t), influenza a virus a/hong kong/4801/2014 (h3n2) recombinant hemagglutinin antigen (unii: 2i1eol437m) (influenza a virus a/hong kong/4801/2014 (h3n2) recombinant hemagglutinin antigen - unii:2i1eol437m), influenza b virus b/brisbane/60/2008 recombinant hemagglutinin antigen (unii: 058u2312cr) (influenza b virus b/bri - influenza a virus a/michigan/45/2015 (h1n1) recombinant hemagglutinin antigen 45 ug in 0.5 ml - flublok is a vaccine indicated for active immunization against disease caused by influenza a virus subtypes and influenza type b virus contained in the vaccine. flublok is approved for use in persons 18 years of age and older. flublok is contraindicated in individuals with known severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine (see postmarketing experience [6.2] and description [11] ). pregnancy outcomes in women who have been exposed to flublok during pregnancy are being monitored. contact: protein sciences corporation by calling 1-888-855-7871. all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. available data on flublok administered to pregnant women are insufficient to inform vaccine-associated risks in pregnant women. a developmental study of flublok has been performed in

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

sanofi pasteur inc. - influenza a virus a/michigan/45/2015 x-275 (h1n1) antigen (formaldehyde inactivated) (unii: 8ksk0802bp) (influenza a virus a/michigan/45/2015 x-275 (h1n1) hemagglutinin antigen (formaldehyde inactivated) - unii:116749898h) - influenza a virus a/michigan/45/2015 x-275 (h1n1) hemagglutinin antigen (formaldehyde inactivated) 9 ug in 0.1 ml

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

protein sciences corporation - influenza a virus a/michigan/45/2015 (h1n1) recombinant hemagglutinin antigen (unii: 69h0yj871t) (influenza a virus a/michigan/45/2015 (h1n1) recombinant hemagglutinin antigen - unii:69h0yj871t) - influenza a virus a/michigan/45/2015 (h1n1) recombinant hemagglutinin antigen 45 ug in 0.5 ml

Australia - English - 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 - English - 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 - English - 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.

Australia - English - 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - influenza virus a/michigan/45/2015 (h1n1) pdm09 - like strain 15ug (a/singapore/gp1908/2015, ivr-180); influenza virus a/switzerland/8060/2017 (h3n2) like strain 15ug (a/brisbane/1/2018, nymc x-311); influenza virus b/colorado/06/2017 - like strain 15ug (b/maryland/15/2016, nymc bx-69a (victoria lineage)); influenza virus b/phuket/3073/2013 - like strain 15ug (b/phuket/3073/2013, wild type (yamagata lineage)) - suspension for injection - 0.5 ml - active: influenza virus a/michigan/45/2015 (h1n1) pdm09 - like strain 15ug (a/singapore/gp1908/2015, ivr-180) influenza virus a/switzerland/8060/2017 (h3n2) like strain 15ug (a/brisbane/1/2018, nymc x-311) influenza virus b/colorado/06/2017 - like strain 15ug (b/maryland/15/2016, nymc bx-69a (victoria lineage)) influenza virus b/phuket/3073/2013 - like strain 15ug (b/phuket/3073/2013, wild type (yamagata lineage)) excipient: d-alpha-tocopheryl acid succinate dibasic sodium phosphate dodecahydrate magnesium chloride hexahydrate monobasic potassium phosphate octoxinol polysorbate 80 potassium chloride sodium chloride water for injection - 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. the use of fluarix tetra should be based on official recommendations.