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

glaxosmithkline australia pty ltd - fluticasone propionate, quantity: 250 microgram/actuation; salmeterol xinafoate, quantity: 36.3 microgram/actuation (equivalent: salmeterol, qty 25 microgram/actuation) - inhalation, pressurised - excipient ingredients: norflurane - 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 - fluticasone propionate, quantity: 125 microgram/actuation; salmeterol xinafoate, quantity: 36.3 microgram/actuation (equivalent: salmeterol, qty 25 microgram/actuation) - inhalation, pressurised - excipient ingredients: norflurane - 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 - 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.

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: 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 - rotavirus, quantity: 1000000 ccid50/dose - oral liquid, suspension - excipient ingredients: sucrose; water for injections; adipic acid; sodium hydroxide; glucose monohydrate; sodium chloride; potassium chloride; magnesium sulfate heptahydrate; ferric nitrate nonahydrate; dibasic sodium phosphate dihydrate; sodium pyruvate; folic acid; calcium pantothenate; inositol; choline chloride; nicotinamide; pyridoxine hydrochloride; thiamine hydrochloride; riboflavine; cystine; tyrosine; arginine; glycine; histidine; isoleucine; leucine; lysine; methionine; phenylalanine; threonine; tryptophan; serine; valine; glutamine; calcium chloride dihydrate; sodium bicarbonate - rotarix is indicated for the prevention of rotavirus gastroenteritis. see section 5.1 pharmacodynamic properties - clinical trials.

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

glaxosmithkline australia pty ltd - pertussis filamentous haemagglutinin, quantity: 50 microgram/ml; pertactin, quantity: 16 microgram/ml; tetanus toxoid, quantity: 80 iu/ml; pertussis toxoid, quantity: 50 microgram/ml; diphtheria toxoid, quantity: 60 iu/ml - injection, suspension - excipient ingredients: water for injections; aluminium hydroxide hydrate; sodium chloride - infanrix is indicated as fourth and fifth dose for children from 15 months of age up to and including 6 years of age who have been immunised previously with three or four doses of diphtheria, tetanus and pertussis (whole-cell) vaccine. indications as of 8th january 1997 - infanrix (dtpa) is indicated for active primary immunisation against diphtheria, tetanus and pertussis when commenced between 2 months and 12 months of age. infanrix (dtpa) is also indicated as fourth and fifth dose for children from 15 months of age up to and including 6 years of age who have been immunised previously with three or four doses of diphtheria,tetanus and pertussis (whole-cell or acellular) vaccine.

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

glaxosmithkline australia pty ltd - pertussis filamentous haemagglutinin, quantity: 50 microgram/ml; pertactin, quantity: 16 microgram/ml; pertussis toxoid, quantity: 50 microgram/ml; tetanus toxoid, quantity: 20 lfu/ml; diphtheria toxoid, quantity: 50 lfu/ml - injection, suspension - excipient ingredients: water for injections; aluminium hydroxide hydrate; sodium chloride - infanrix is indicated as fourth and fifth dose for children from 15 months of age up to and including 6 years of age who have been immunised previously with three or four doses of diphtheria, tetanus and pertussis (whole-cell) vaccine. indications as of 8th january 1997 - infanrix (dtpa) is indicated for active primary immunisation against diphtheria, tetanus and pertussis when commenced between 2 months and 12 months of age. infanrix (dtpa) is also indicated as fourth and fifth dose for children from 15 months of age up to and including 6 years of age who have been immunised previously with three or four doses of diphtheria,tetanus and pertussis (whole-cell or acellular) vaccine.

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

glaxosmithkline australia pty ltd - fluticasone propionate, quantity: 250 microgram/actuation; salmeterol xinafoate, quantity: 36.3 microgram/actuation (equivalent: salmeterol, qty 25 microgram/actuation) - inhalation, pressurised - excipient ingredients: norflurane - 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. seretide is not indicated for the initiation of bronchodilator therapy in copd.

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

glaxosmithkline australia pty ltd - fluticasone propionate, quantity: 125 microgram/actuation; salmeterol xinafoate, quantity: 36.3 microgram/actuation (equivalent: salmeterol, qty 25 microgram/actuation) - inhalation, pressurised - excipient ingredients: norflurane - 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. seretide is not indicated for the initiation of bronchodilator therapy in copd.