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

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

New Zealand - Inggeris - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - fluticasone propionate 100ug (micronised);  ;  ;  ; salmeterol xinafoate 72.5ug equivalent to 50 µg of salmeterol base;  ;  ;   - powder for inhalation - 100µg/50µg - active: fluticasone propionate 100ug (micronised)       salmeterol xinafoate 72.5ug equivalent to 50 µg of salmeterol base       excipient: lactose monohydrate - seretide is indicated for the regular treatment of asthma (reversible obstructive airways disease), where use of a combination product (bronchodilator and inhaled corticosteroid) is appropriate. this may include: patients on effective maintenance doses of both long-acting beta-agonists and inhaled corticosteroids using separate therapy. patients who are not adequately controlled on current inhaled corticosteroid therapy. patients who are not adequately controlled on 'as needed' short-acting beta-agonistsm as an alternative to initiation of maintenance therapy with moderate or high doses of inhaled corticosteroids alone. seretide should not typically be used for the initial management of asthma, unless symptoms are severely uncontrolled, nor in patients whose asthma can be managed by occasional use of short-acting beta-2 agonists. seretide should not be used in the treatment of acute asthmatic symptoms.

New Zealand - Inggeris - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - fluticasone propionate 250ug (micronised);  ;  ;  ; salmeterol xinafoate 72.5ug equivalent to 50 µg of salmeterol base;  ;  ;   - powder for inhalation - 250µg/50µg - active: fluticasone propionate 250ug (micronised)       salmeterol xinafoate 72.5ug equivalent to 50 µg of salmeterol base       excipient: lactose monohydrate - seretide is indicated for the regular treatment of asthma (reversible obstructive airways disease), where use of a combination product (bronchodilator and inhaled corticosteroid) is appropriate. this may include: patients on effective maintenance doses of both long-acting beta-agonists and inhaled corticosteroids using separate therapy. patients who are not adequately controlled on current inhaled corticosteroid therapy. patients who are not adequately controlled on 'as needed' short-acting beta-agonistsm as an alternative to initiation of maintenance therapy with moderate or high doses of inhaled corticosteroids alone. seretide should not typically be used for the initial management of asthma, unless symptoms are severely uncontrolled, nor in patients whose asthma can be managed by occasional use of short-acting beta-2 agonists. seretide should not be used in the treatment of acute asthmatic symptoms.

New Zealand - Inggeris - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - fluticasone propionate 500ug (micronised);  ;  ;  ; salmeterol xinafoate 72.5ug equivalent to 50 µg of salmeterol base;  ;  ;   - powder for inhalation - 500µg/50µg - active: fluticasone propionate 500ug (micronised)       salmeterol xinafoate 72.5ug equivalent to 50 µg of salmeterol base       excipient: lactose monohydrate - seretide is indicated for the regular treatment of asthma (reversible obstructive airways disease), where use of a combination product (bronchodilator and inhaled corticosteroid) is appropriate. this may include: patients on effective maintenance doses of both long-acting beta-agonists and inhaled corticosteroids using separate therapy. patients who are not adequately controlled on current inhaled corticosteroid therapy. patients who are not adequately controlled on 'as needed' short-acting beta-agonistsm as an alternative to initiation of maintenance therapy with moderate or high doses of inhaled corticosteroids alone. seretide should not typically be used for the initial management of asthma, unless symptoms are severely uncontrolled, nor in patients whose asthma can be managed by occasional use of short-acting beta-2 agonists. seretide should not be used in the treatment of acute asthmatic symptoms.

Ireland - Inggeris - HPRA (Health Products Regulatory Authority)

fannin limited - fluticasone propionate; salmeterol xinafoate - pressurised inhalation, suspension - 25 / 125 microgram(s)/dose - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; salmeterol and fluticasone

Ireland - Inggeris - HPRA (Health Products Regulatory Authority)

fannin limited - fluticasone propionate; salmeterol xinafoate - pressurised inhalation, suspension - 25/250 microgram(s)/dose - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; salmeterol and fluticasone

New Zealand - Inggeris - Medsafe (Medicines Safety Authority)

rex medical ltd - fluticasone propionate 0.05mg (additional 5% overage); salmeterol xinafoate 0.0363mg equivalent to 0.025 mg salmeterol - aerosol inhaler, metered dose - 0.05mg/0.025mg per dose - active: fluticasone propionate 0.05mg (additional 5% overage) 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.

New Zealand - Inggeris - 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.

New Zealand - Inggeris - Medsafe (Medicines Safety Authority)

rex medical ltd - fluticasone propionate 0.25mg; salmeterol xinafoate 0.0363mg equivalent to 0.025 mg salmeterol - aerosol inhaler, metered dose - 0.25mg/0.025mg per dose - active: fluticasone propionate 0.25mg 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.

Ireland - Inggeris - HPRA (Health Products Regulatory Authority)

fannin (uk) ltd - fluticasone propionate; salmeterol xinafoate - pressurised inhalation, suspension - 25 / 125 microgram(s)/dose - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; salmeterol and fluticasone