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

glaxosmithkline australia pty ltd - fluticasone propionate, quantity: 50 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 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 - 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: 50 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 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 clnical 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 - salmeterol xinafoate, quantity: 72.5 microgram/actuation (equivalent: salmeterol, qty 50 microgram/actuation); fluticasone propionate, quantity: 500 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.

Singapore - English - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - fluticasone propionate; salmeterol - aerosol, spray - 125 mcg - fluticasone propionate 125 mcg; salmeterol 25 mcg

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

alphapharm 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. evocair is not indicated for the initiation of bronchodilator therapy in copd.

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

alphapharm 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. evocair is not indicated for the initiation of bronchodilator therapy in copd.

New Zealand - English - Medsafe (Medicines Safety Authority)

rex medical ltd - fluticasone propionate 0.125mg - aerosol inhaler, metered dose - 0.125 mg/dose - active: fluticasone propionate 0.125mg excipient: ethanol lecithin norflurane - floair inhaler is indicated for the long-term prevention of bronchospasm in adults or children with mild, moderate or severe asthma. floair inhaler is also indicated for adults and children with severe asthma dependent on oral corticosteroids for symptom control. introduction of floair inhaler may allow the requirement for oral corticosteroids to be reduced or eliminated over time. floair inhaler is not indicated for the treatment of acute asthma symptoms, for which a fast acting inhaled bronchodilator (e.g. salbutamol) should be used.

New Zealand - English - Medsafe (Medicines Safety Authority)

rex medical ltd - fluticasone propionate 0.125mg; salmeterol xinafoate 0.0363mg equivalent to 0.025 mg salmeterol - aerosol inhaler, metered dose - 0.125mg/0.025mg per dose - active: fluticasone propionate 0.125mg salmeterol xinafoate 0.0363mg equivalent to 0.025 mg salmeterol excipient: ethanol lecithin norflurane - reversible obstructive airways disease (road): indicated in the regular treatment of reversible obstructive airways disease (road), including asthma in children and adults, where use of a combination (bronchodilator and inhaled corticosteroid) is appropriate. this may include: · patients on effective maintenance doses of long-acting beta-agonists and inhaled corticosteroids. · patients who are symptomatic on current inhaled corticosteroid therapy. · patients who are symptomatic on as needed short-acting beta agonists, as an alternative to initiation of maintenance therapy with moderate or high doses of inhaled corticosteroid alone.