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

glaxosmithkline australia pty ltd - fluticasone propionate, quantity: 250 microgram/actuation; salmeterol xinafoate, quantity: 72.5 microgram/actuation (equivalent: salmeterol, qty 50 microgram/actuation) - inhalation, powder for - excipient ingredients: lactose monohydrate - for the regular treatment of asthma, where the use of a combination product is appropriate. this may include:,*patients on effective maintenance doses of long-acting beta2-agonists and inhaled corticosteroids.,*patients who are symptomatic on current inhaled corticosteroid therapy.,for the symptomatic treatment of patients with severe copd (fev1<50% predicted normal) and a history of repeated exacerbations who have significant symptoms despite regular beta-2 agonist bronchodilator therapy. pavtide is not indicated for the initiation of bronchodilator therapy in copd.

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

glaxosmithkline australia pty ltd - salmeterol xinafoate, quantity: 72.5 microgram/actuation (equivalent: salmeterol, qty 50 microgram/actuation); fluticasone propionate, quantity: 100 microgram/actuation - inhalation, powder for - excipient ingredients: lactose monohydrate - for the regular treatment of asthma, where the use of a combination product is appropriate. this may include:,*patients on effective maintenance doses of long-acting beta-2-agonists and inhaled corticosteroids.,*patients who are symptomatic on current inhaled corticosteroid therapy.,*initiation of maintenance therapy in those patients with moderate persistent asthma not adequately controlled on "as needed" reliever medication, and who have moderate/severe airway limitation and daily symptoms requiring medication every day (see clinical trials).,for the symptomatic treatment of patients with severe copd (fev1<50% predicted normal) and a history of repeated exacerbations who have significant symptoms despite regular beta-2 agonist bronchodilator therapy. pavtide is not indicated for the initiation of bronchodilator therapy in copd.

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

glaxosmithkline australia pty ltd - vilanterol trifenatate, quantity: 40 microgram (equivalent: vilanterol, qty 25 microgram); fluticasone furoate, quantity: 100 microgram - inhalation, powder for - excipient ingredients: magnesium stearate; lactose monohydrate - copd,breo ellipta is indicated for symptomatic treatment of patients with copd with a fev1 <70% predicted normal (post-bronchodilator) in patients with an exacerbation history despite regular bronchodilator therapy.,breo ellipta is not indicated for the initiation of bronchodilator therapy in copd.,asthma,breo ellipta is indicated in the regular treatment of moderate to severe asthma in patients who require a medium to high dose inhaled corticosteroid combined with a long-acting beta-2-agonist.,vilanterol, an active ingredient in breo ellipta, is a long-acting beta-2-agonist (laba). a class effect of all labas can be an increased risk of asthma death (see precautions).

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

glaxosmithkline australia pty ltd - fluticasone furoate, quantity: 200 microgram; vilanterol trifenatate, quantity: 40 microgram (equivalent: vilanterol, qty 25 microgram) - inhalation, powder for - excipient ingredients: magnesium stearate; lactose monohydrate - asthma,breo ellipta is indicated in the regular treatment of moderate to severe asthma in patients who require a medium to high dose inhaled corticosteroid combined with a long-acting beta-2-agonist.,vilanterol, an active ingredient in breo ellipta, is a long-acting beta-2-agonist (laba). a class effect of all labas can be an increased risk of asthma death (see precautions).

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

glaxosmithkline australia pty ltd - dutasteride, quantity: 500 microgram; tamsulosin hydrochloride, quantity: 400 microgram - capsule, modified release - excipient ingredients: maize starch; carrageenan; gelatin; purified talc; butylated hydroxytoluene; iron oxide yellow; titanium dioxide; iron oxide red; glycerol; medium chain triglycerides; potassium chloride; microcrystalline cellulose; methacrylic acid - ethyl acrylate copolymer (1:1); purified water; triethyl citrate; lecithin; glyceryl caprylate/caprate; sunset yellow fcf; carnauba wax; hypromellose; propylene glycol; butan-1-ol; isopropyl alcohol; ethanol; shellac; simethicone; iron oxide black; strong ammonia solution; potassium hydroxide - duodart is indicated for the management of moderate to severe symptomatic benign prostatic hyperplasia (bph).

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

glaxosmithkline australia pty ltd - tetanus toxoid, quantity: 20 lfu/ml; poliovirus, quantity: 80 agu/ml; pertussis filamentous haemagglutinin, quantity: 50 microgram/ml; poliovirus, quantity: 16 agu/ml; pertactin, quantity: 16 microgram/ml; poliovirus, quantity: 64 agu/ml; pertussis toxoid, quantity: 50 microgram/ml; diphtheria toxoid, quantity: 50 lfu/ml - injection, solution - excipient ingredients: aluminium hydroxide hydrate; water for injections; neomycin sulfate; polymyxin b sulfate; sodium chloride; glucose monohydrate; polysorbate 80; 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; nicoti - 1. infanrix-ipv is indicated for use in a three dose primary schedule for immunisation of infants from 6 weeks of age and over, against diphtheria, tetanus, pertussis and poliomyelitis. infanrix-ipv is also indicated as a single booster dose for children, up to and including 6 years of age, who have previously been immunised against diphthereia, tetanus, pertussis and polio.

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

glaxosmithkline australia pty ltd - hepatitis a virus antigen, quantity: 720 elisa unit - injection, suspension - excipient ingredients: aluminium hydroxide hydrate; aluminium; polysorbate 20; dibasic sodium phosphate heptahydrate; monobasic potassium phosphate; sodium chloride; potassium chloride; water for injections; acetic acid; leucine; phenylalanine; methionine; lysine hydrochloride; isoleucine; valine; histidine; threonine; tryptophan; alanine; arginine; proline; tyrosine; serine; sodium acetate; dibasic potassium phosphate; magnesium chloride hexahydrate; glycine - havrix is indicated for active immunisation against hepatitis a virus (hav) infection in susceptible subjects at risk of exposure to hav. havrix junior is indicated in subjects aged 2 to 15 years and havrix 1440 is indicated in subjects aged 16 years and older. in areas of low prevalence of hepatitis a, immunisation with havrix is particularly recommended in the following subjects: travellers : persons travelling to areas of intermediate or high endemicity for hepatitis a. these areas include africa, asia, india, the pacific islands, the mediterranean basin, the middle east, central and south america. armed forces : armed forces personnel who travel to higher endemicity areas or to areas where hygiene is poor, have an increased risk of hav infection. persons for whom hepatitis a is an occupational hazard or for whom there is an increased risk of transmission. these include: employees in day-care centres particularly in situations where children have not been toilet trained; teachers and other close contacts o

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

glaxosmithkline australia pty ltd - hepatitis a virus antigen, quantity: 720 elisa unit - injection, suspension - excipient ingredients: aluminium hydroxide hydrate; aluminium; polysorbate 20; dibasic sodium phosphate heptahydrate; monobasic potassium phosphate; sodium chloride; potassium chloride; water for injections; acetic acid; glycine; leucine; phenylalanine; methionine; lysine hydrochloride; isoleucine; valine; histidine; threonine; tryptophan; alanine; arginine; proline; tyrosine; serine; sodium acetate; dibasic potassium phosphate; magnesium chloride hexahydrate - havrix is indicated for active immunisation against hepatitis a virus (hav) infection in susceptible subjects at risk of exposure to hav. havrix junior is indicated in subjects aged 2 to 15 years and havrix 1440 is indicated in subjects aged 16 years and older. in areas of low prevalence of hepatitis a, immunisation with havrix is particularly recommended in the following subjects: travellers : persons travelling to areas of intermediate or high endemicity for hepatitis a. these areas include africa, asia, india, the pacific islands, the mediterranean basin, the middle east, central and south america. armed forces : armed forces personnel who travel to higher endemicity areas or to areas where hygiene is poor, have an increased risk of hav infection. persons for whom hepatitis a is an occupational hazard or for whom there is an increased risk of transmission. these include: employees in day-care centres particularly in situations where children have not been toilet trained; teachers and other close contacts o

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

glaxosmithkline australia pty ltd - hepatitis a virus antigen, quantity: 1440 elisa unit - injection, suspension - excipient ingredients: polysorbate 20; dibasic sodium phosphate heptahydrate; monobasic potassium phosphate; sodium chloride; potassium chloride; water for injections; aluminium hydroxide hydrate; acetic acid; leucine; phenylalanine; methionine; lysine hydrochloride; isoleucine; valine; histidine; threonine; tryptophan; alanine; arginine; proline; tyrosine; serine; sodium acetate; dibasic potassium phosphate; magnesium chloride hexahydrate; glycine - havrix is indicated for active immunisation against hepatitis a virus (hav) infection in susceptible subjects at risk of exposure to hav. havrix junior is indicated in subjects aged 2 to 15 years and havrix 1440 is indicated in subjects aged 16 years and older. in areas of low prevalence of hepatitis a, immunisation with havrix is particularly recommended in the following subjects: travellers : persons travelling to areas of intermediate or high endemicity for hepatitis a. these areas include africa, asia, india, the pacific islands, the mediterranean basin, the middle east, central and south america. armed forces : armed forces personnel who travel to higher endemicity areas or to areas where hygiene is poor, have an increased risk of hav infection. persons for whom hepatitis a is an occupational hazard or for whom there is an increased risk of transmission. these include: employees in day-care centres particularly in situations where children have not been toilet trained; teachers and other close contacts o

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

glaxosmithkline australia pty ltd - hepatitis a virus antigen, quantity: 1440 elisa unit - injection, suspension - excipient ingredients: polysorbate 20; dibasic sodium phosphate heptahydrate; monobasic potassium phosphate; sodium chloride; potassium chloride; water for injections; aluminium hydroxide hydrate; acetic acid; glycine; leucine; phenylalanine; methionine; lysine hydrochloride; isoleucine; valine; histidine; threonine; tryptophan; alanine; arginine; proline; tyrosine; serine; sodium acetate; dibasic potassium phosphate; magnesium chloride hexahydrate - havrix is indicated for active immunisation against hepatitis a virus (hav) infection in susceptible subjects at risk of exposure to hav. havrix junior is indicated in subjects aged 2 to 15 years and havrix 1440 is indicated in subjects aged 16 years and older. in areas of low prevalence of hepatitis a, immunisation with havrix is particularly recommended in the following subjects: travellers : persons travelling to areas of intermediate or high endemicity for hepatitis a. these areas include africa, asia, india, the pacific islands, the mediterranean basin, the middle east, central and south america. armed forces : armed forces personnel who travel to higher endemicity areas or to areas where hygiene is poor, have an increased risk of hav infection. persons for whom hepatitis a is an occupational hazard or for whom there is an increased risk of transmission. these include: employees in day-care centres particularly in situations where children have not been toilet trained; teachers and other close contacts o