USA - engelsk - NLM (National Library of Medicine)

glaxosmithkline biologicals sa - 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/darwin/6/2021 ivr-227 (h3n2) antigen (formaldehyde inactivated) (unii: f5qv7af326) (influenza a virus a/darwin/6/2021 ivr-227 (h3n2) hemagglutinin antigen (formaldehyde inactivated) - unii:n969qk7xd2), influenza b virus b/austria/1359417/2021 bvr-26 antigen - influenza a virus a/singapore/gp1908/2015 ivr-180 (h1n1) hemagglutinin antigen (formaldehyde inactivated) 15 ug in 0.5 ml - fluarix quadrivalent is indicated for active immunization for the prevention of disease caused by influenza a subtype viruses and type b viruses contained in the vaccine [see description (11)] . fluarix quadrivalent is approved for use in persons aged 6 months and older. do not administer fluarix quadrivalent to anyone with a history of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine, including egg protein, or following a previous administration of any influenza 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. available data from a pregnancy registry do not suggest an increased risk of major birth defects and miscarriage in individuals who received fluarix quadrivalent within 28 days prior to conception or during pregnancy (see d

Australien - engelsk - 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; water for injections - for the prevention of influenza caused by influenza virus, types a and b contained in the vaccine. the vaccine is indicated for use only in persons aged 5 years and over. for full details regarding recommendations for influenza vaccination, please refer to the relevant national immunisation guidelines.

Australien - engelsk - 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.

Australien - engelsk - 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.

Singapore - engelsk - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - influenza virus (nh) a/california/7/2009 (h1n1)pdm09 - like strain - injection - 15 mcg haemagglutinin/0.5 ml

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - influenza virus haemagglutinin -

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - influenza virus haemagglutinin -

Malaysia - engelsk - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

glaxosmithkline pharmaceutical sdn. bhd. - influenza split virus, inactivated -

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

viatris limited - influenza virus a/michigan/45/2015 (h1n1) pdm09 - like strain 15ug (a/singapore/gp1908/2015, ivr-180); influenza virus a/singapore/infimh-16-0019/2016 (h3n2) - like strain 15ug (a/singapore/infimh-16-0019/2016, nib-104); influenza virus b/phuket/3073/2013 - like strain 15ug (b/phuket/3073/2013, wild type) - 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/singapore/infimh-16-0019/2016 (h3n2) - like strain 15ug (a/singapore/infimh-16-0019/2016, nib-104) influenza virus b/phuket/3073/2013 - like strain 15ug (b/phuket/3073/2013, wild type) excipient: calcium chloride dihydrate dibasic sodium phosphate dihydrate magnesium chloride hexahydrate monobasic potassium phosphate potassium chloride sodium chloride water for injection - for the prevention of influenza virus, types a and b in adults and children older than 6 months in accordance with the recommendations in the national immunisation guideline.