European Union - English - EMA (European Medicines Agency)

ology bioservices ireland ltd - influenza virus (whole virion, inactivated), containing antigen of: a/vietnam/1203/2004 (h5n1) - influenza, human; immunization; disease outbreaks - influenza vaccines - active immunisation against h5n1 subtype of influenza a virus. this indication is based on immunogenicity data from subjects from the age of 6 months onwards following administration of two doses of vaccine prepared with h5n1 subtype strains. vepacel should be used in accordance with official guidance.,

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

novartis vaccines and diagnostics ltd - influenza a virus a/california/7/2009(h1n1)-like hemagglutinin antigen (propiolactone inactivated) (unii: k9p8pva2ug) (influenza a virus a/california/7/2009(h1n1)-like hemagglutinin antigen (propiolactone inactivated) - unii:k9p8pva2ug) - influenza a virus a/california/7/2009(h1n1)-like hemagglutinin antigen (propiolactone inactivated) 15 ug in 0.5 ml - influenza a (h1n1) 2009 monovalent vaccine is an inactivated influenza virus vaccine indicated for immunization of persons 4 years of age and older against influenza disease caused by pandemic (h1n1) 2009 virus. influenza a (h1n1) 2009 monovalent vaccine should not be administered to anyone with known systemic hypersensitivity reactions to egg proteins (eggs or egg products), or to any component of influenza a (h1n1) 2009 monovalent vaccine, or who has had a life-threatening reaction to previous influenza vaccinations [see description (11)]. novartis’ influenza a (h1n1) 2009 monovalent vaccine and seasonal trivalent influenza virus vaccine (fluvirin) are manufactured by the same process. available information for fluvirin is provided in this section. pregnancy category c: animal reproduction studies have not been conducted with influenza a (h1n1) 2009 monovalent vaccine or fluvirin. it is also not known whether influenza a (h1n1) 2009 monovalent vaccine or fluvirin can cause fetal harm when administered to

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

glaxosmithkline australia pty ltd - diphtheria toxoid, quantity: 2 iu; pertussis toxoid, quantity: 8 microgram; tetanus toxoid, quantity: 20 iu; pertactin, quantity: 2.5 microgram; pertussis filamentous haemagglutinin, quantity: 8 microgram; poliovirus, quantity: 32 agu - injection, suspension - excipient ingredients: polysorbate 80; aluminium hydroxide hydrate; sodium chloride; neomycin sulfate; water for injections; aluminium phosphate; polymyxin b sulfate; glucose monohydrate; ascorbic acid; calcium chloride dihydrate; ferric nitrate nonahydrate; potassium chloride; magnesium sulfate heptahydrate; monobasic potassium phosphate; dibasic sodium phosphate; adenine sulfate dihydrate; adenosine triphosphate disodium; adenosine phosphate; cholesterol; deoxyribose; glutathione; guanine hydrochloride monohydrate; sodium hypoxanthine; ribose; sodium acetate; thymine; uracil; sodium xanthine; dl-alanine; arginine hydrochloride; dl-aspartic acid; cysteine hydrochloride; cystine dihydrochloride; dl-glutamic acid; glutamine; glycine; histidine hydrochloride; isoleucine; hydroxyproline; dl-leucine; lysine hydrochloride; dl-methionine; dl-phenylalanine; proline; dl-serine; dl-threonine; dl-tryptophan; tyrosine disodium; dl-valine; biotin; ergocalciferol; calcium pantothenate; choline chloride; folic acid; inositol; menadione; nicotinic acid; nicotinamide; aminobenzoic acid; pyridoxal hydrochloride; pyridoxine hydrochloride; riboflavine; thiamine hydrochloride; retinol acetate; dl-alpha-tocopheryl phosphate disodium - boostrix-ipv is indicated for booster vaccination against diphtheria, tetanus, pertussis and polio of individuals from the age of four years onwards.,boostrix-ipv is also indicated for passive protection against pertussis in early infancy following maternal immunisation during pregnancy (see section 4.2 dose and method of administration, section 4.6 fertility, pregnancy and lactation and 5.1 pharmacodynamic properties).,the nhmrc currently recommends only 4 doses of polio vaccines in childhood, and that polio boosters for adults are not necessary unless they are at special risk, such as:,? travellers to areas or countries where poliomyelitis is epidemic or endemic;,? health care workers in possible contact with poliomyelitis cases.,for those exposed to continuing risk of infection a single booster dose is desirable every 10 years.,the nhmrc currently recommends boosting against diphtheria, tetanus and pertussis using an adolescent/adult formulation dtpa at 15 to 17 years of age. before the eighth birthday, dtp-containing vaccines should be given, as they contain a larger dose of diphtheria toxoid. after the eighth birthday, smaller doses of toxoid (adult/adolescent formulation dtpa or dt-containing vaccines) should be given.,a booster dose of dtpa is also recommended:,? before planning pregnancy, or for both parents as soon as possible after delivery of an infant,? for adults working with young children,? for any adult expressing an interest in receiving a booster dose of dtpa, provided that a primary course of dtp vaccine has been given in the past.,clinical data has demonstrated that in adults with an unknown history of pertussis vaccination, the majority had an immunogenic response to pertussis when given boostrix-ipv (see section 5.1 pharmacodynamic properties).,finally, all adults who reach the age of 50 years without having received a boosting dose of dt in the previous 5 years should receive a further boosting dose of dt, where the adult/adolescent formulation dtpa can be used instead.,boostrix-ipv is not intended for primary immunisation.

New Zealand - English - Medsafe (Medicines Safety Authority)

seqirus (nz) ltd - influenza virus a (h1n1) haemagglutinin 7.5ug (a/victoria/4897/2022 (h1n1)pdm09-like virus (a/victoria/4897/2022 (ivr-238))); influenza virus a (h3n2) haemagglutinin 7.5ug (a/thailand/8/2022 (h3n2)-like virus (a/thailand/8/2022 (ivr-237))); influenza virus b (victoria) haemagglutinin 7.5ug (b/austria/1359417/2021(b/victoria lineage)-like virus (b/austria/1359417/2021 (bvr-26))); influenza virus b (yamagata) haemagglutinin 7.5ug (b/phuket/3073/2013-like virus (b/phuket/3073/2013 (bvr-1b))) - suspension for injection - 30 mcg/0.25ml - active: influenza virus a (h1n1) haemagglutinin 7.5ug (a/victoria/4897/2022 (h1n1)pdm09-like virus (a/victoria/4897/2022 (ivr-238))) influenza virus a (h3n2) haemagglutinin 7.5ug (a/thailand/8/2022 (h3n2)-like virus (a/thailand/8/2022 (ivr-237))) influenza virus b (victoria) haemagglutinin 7.5ug (b/austria/1359417/2021(b/victoria lineage)-like virus (b/austria/1359417/2021 (bvr-26))) influenza virus b (yamagata) haemagglutinin 7.5ug (b/phuket/3073/2013-like virus (b/phuket/3073/2013 (bvr-1b))) excipient: calcium chloride dihydrate dibasic sodium phosphate monobasic potassium phosphate monobasic sodium phosphate potassium chloride sodium chloride water for injection - for the prevention of influenza caused by influenza virus, types a and b contained in the vaccine. afluria quad junior vaccine is indicated for use in children aged 6 months to 35 months inclusive. for full details regarding recommendations for influenza vaccination, please refer to the relevant national immunisation guidelines.

New Zealand - English - Medsafe (Medicines Safety Authority)

seqirus (nz) ltd - influenza virus a (h1n1) haemagglutinin 15ug (a/wisconsin/67/2022 (h1n1)pdm09-like virus (a/georgia/12/2022 (cvr-167))); influenza virus a (h3n2) haemagglutinin 15ug (a/massachusetts/18/2022 (h3n2)-like virus (a/sydney/1304/2022)); influenza virus b (victoria) haemagglutinin 15ug (b/austria/1359417/2021-like virus (b/victoria lineage) (b/singapore/wuh4618/2021)); influenza virus b (yamagata) haemagglutinin 15ug (b/phuket/3073/2013-like virus (b/yamagata lineage) (b/singapore/inftt-16-0610/2016)) - suspension for injection - 60 mcg/0.5ml - active: influenza virus a (h1n1) haemagglutinin 15ug (a/wisconsin/67/2022 (h1n1)pdm09-like virus (a/georgia/12/2022 (cvr-167))) influenza virus a (h3n2) haemagglutinin 15ug (a/massachusetts/18/2022 (h3n2)-like virus (a/sydney/1304/2022)) influenza virus b (victoria) haemagglutinin 15ug (b/austria/1359417/2021-like virus (b/victoria lineage) (b/singapore/wuh4618/2021)) influenza virus b (yamagata) haemagglutinin 15ug (b/phuket/3073/2013-like virus (b/yamagata lineage) (b/singapore/inftt-16-0610/2016)) excipient: dibasic sodium phosphate dihydrate magnesium chloride hexahydrate monobasic potassium phosphate potassium chloride sodium chloride water for injection - flucelvax quad is indicated for the prevention of influenza caused by influenza virus types a and b contained in the vaccine. the vaccine is indicated for use in individuals 6 months of age and above. for full details regarding recommendations for influenza vaccination, please refer to the relevant national immunisation guidelines.

European Union - English - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - split influenza virus inactivated, containing antigen equivalent to a/california/07/2009 (h1n1)-derived strain used nymc x-179a - influenza, human; immunization; disease outbreaks - influenza vaccines - prophylaxis of influenza caused by a (h1n1)v 2009 virus. pandemrix should only be used if the recommended annual seasonal trivalent / quadrivalent influenza vaccines are not available and if immunisation against (h1n1)v is considered necessary (see sections 4.4 and 4.8).pandemrix should be used in accordance with official guidance.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

split virion, inactivated) suspension for injection 0.5ml pre-filled syringes (sanofi - influenza virus split virion - suspension for injection

New Zealand - English - Medsafe (Medicines Safety Authority)

seqirus (nz) ltd - influenza virus a/hong kong/4801/2014 (h3n2) - like strain 15ug (a/hong kong/4801/2014 (x-263b)); influenza virus a/michigan/45/2015 (h1n1) pdm09 - like strain 15ug (a/singapore/gp1908/2015 (ivr-180)); influenza virus b/brisbane/60/2008 - like strain 15ug (b/brisbane/46/2015) - suspension for injection - 0.5 ml - active: influenza virus a/hong kong/4801/2014 (h3n2) - like strain 15ug (a/hong kong/4801/2014 (x-263b)) influenza virus a/michigan/45/2015 (h1n1) pdm09 - like strain 15ug (a/singapore/gp1908/2015 (ivr-180)) influenza virus b/brisbane/60/2008 - like strain 15ug (b/brisbane/46/2015) excipient: calcium chloride dihydrate dibasic sodium phosphate monobasic potassium phosphate monobasic sodium phosphate dihydrate potassium chloride sodium chloride water for injection - fluvax is indicated for the prevention of influenza caused by infuenza virus, types a and b. for the southern hemisphere 2017 season, the vaccine is indicated for use only in persons aged 5 years and over

New Zealand - English - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - influenza virus a/california/7/2009 (h1n1) - like strain 9ug (a/california/7/2009 nymc x-179a); influenza virus a/texas/50/2012 (h3n2) like strain 9ug (a/texas/50/2012 nymc x-223a); influenza virus b/massachusetts/2/2012 like strain 9ug (wild type) - suspension for injection - 9 mcg - active: influenza virus a/california/7/2009 (h1n1) - like strain 9ug (a/california/7/2009 nymc x-179a) influenza virus a/texas/50/2012 (h3n2) like strain 9ug (a/texas/50/2012 nymc x-223a) influenza virus b/massachusetts/2/2012 like strain 9ug (wild type) excipient: dibasic sodium phosphate dihydrate hydrochloric acid monobasic potassium phosphate potassium chloride sodium chloride sodium hydroxide water for injection - intanza 9mcg is indicated for prophylaxis of influenza in adults from 18 to 59 years of age. the use of intanza 9mcg in new zealand should be based on the ministry of health recommendations for influenza vaccination as published in the current new zealand immunisation handbook.

Singapore - English - HSA (Health Sciences Authority)

seqirus pte. ltd. - influenza virus (sh) a/california/07/2009 (h1n1) pdm09- like strain; influenza virus (sh) a/hong kong/4801/2014 (h3n2) - like strain; influenza virus (sh) b/brisbane/60/2008 - like strain - injection - 15 mcg ha/0.5ml - influenza virus (sh) a/california/07/2009 (h1n1) pdm09- like strain 15 mcg ha/0.5ml; influenza virus (sh) a/hong kong/4801/2014 (h3n2) - like strain 15 mcg ha/0.5ml; influenza virus (sh) b/brisbane/60/2008 - like strain 15 mcg ha/0.5ml