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

astrazeneca pty ltd - budesonide, quantity: 160 microgram/actuation; formoterol fumarate dihydrate, quantity: 5 microgram/actuation; glycopyrronium bromide, quantity: 9 microgram/actuation (equivalent: glycopyrronium, qty 7.2 microgram/actuation) - inhalation, pressurised - excipient ingredients: calcium chloride dihydrate; distearoylphosphatidylcholine; norflurane - maintenance treatment to prevent exacerbations and relieve symptoms in adults with moderate, severe, or very severe chronic obstructive pulmonary disease (copd) who require treatment with a combination of an inhaled corticosteroid (ics), a long-acting beta2-agonist (laba), and a long-acting muscarinic antagonist (lama). breztri aerosphere 160/7.2/5 is not indicated for the initiation of therapy in copd.

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

chiesi australia pty ltd - beclometasone dipropionate, quantity: 200 microgram; formoterol fumarate dihydrate, quantity: 6 microgram - inhalation, pressurised - excipient ingredients: norflurane; ethanol absolute; hydrochloric acid - asthma fostair is indicated in adults (18 years and older) in the treatment of asthma where use of a combination product (inhaled corticosteroid and long-acting beta2-agonist) is appropriate: - patients not adequately controlled with inhaled corticosteroids (ics) and 'as needed' inhaled rapid-acting beta2-agonist or - patients already adequately controlled on both ics and long-acting beta2-agonists (laba). (see section 4.2 dose and method of administration for treatment approaches).

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

astrazeneca pty ltd - budesonide, quantity: 80 microgram; formoterol fumarate dihydrate, quantity: 2.25 microgram - inhalation, pressurised - excipient ingredients: apaflurane; macrogol 1000; povidone - asthma rilast rapihaler is indicated in adults and adolescents (12 years and older), for the treatment of asthma to achieve overall asthma control, including the relief of symptoms and the reduction of the risk of exacerbations (see section 4.2 dose and method of administration). chronic obstructive pulmonary disease (copd) rilast rapihaler 200/6 is indicated for the symptomatic treatment of moderate to severe copd (fev1 < or = 50% predicted normal) in adults with frequent symptoms despite long-acting bronchodilator use, and/or a history of recurrent exacerbations. is not indicated for the initiation of bronchodilator therapy in copd.

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

astrazeneca pty ltd - budesonide, quantity: 160 microgram; formoterol fumarate dihydrate, quantity: 4.5 microgram - inhalation, pressurised - excipient ingredients: povidone; macrogol 1000; apaflurane - asthma indicated in adults and adolescents (12 years and older), for the treatment of asthma to achieve overall asthma control, including the relief of symptoms and the reduction of the risk of exacerbations (see section 4.2 dose and method of administration). chronic obstructive pulmonary disease (copd) indicated for the symptomatic treatment of moderate to severe copd (fev1 < or = 50% predicted normal) in adults with frequent symptoms despite long-acting bronchodilator use, and/or a history of recurrent exacerbations. not indicated for the initiation of bronchodilator therapy in copd.

Kenya - English - Pharmacy and Poisons Board

bliss gvs pharma limited 102, hyde park, saki vihar road, andheri (east) - - formoterol fumarate and budesonide inhalation - pressurised inhalation - each actuation delivers: formoterol fumarate… - formoterol and budesonide

Kenya - English - Pharmacy and Poisons Board

bliss gvs pharma ltd 102, hyde park, saki-vihar road, andheri (east), - formoterol fumarate and budesonide inhalation - pressurised inhalation - each actuation delivers: formoterol fumarate… - formoterol and budesonide

European Union - English - EMA (European Medicines Agency)

astrazeneca ab - formoterol fumarate dihydrate, glycopyrronium bromide, budesonide - pulmonary disease, chronic obstructive - drugs for obstructive airway diseases, - trixeo aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (copd) who are not adequately treated by a combination of an inhaled corticosteroid and a long acting beta2 agonist or combination of a long-acting beta2 agonist and a long acting muscarinic antagonist.

New Zealand - English - Medsafe (Medicines Safety Authority)

sandoz new zealand limited - formoterol fumarate 12ug - powder filled inhalation capsule - 12 mcg - active: formoterol fumarate 12ug excipient: gelatin ink lactose monohydrate - foradil is indicated for the treatment of bronchoconstriction in adults and children six years of age and over with asthma as an add-on to inhaled corticosteroid (ics) treatment. in the management of asthma, foradil should be used only as an adjunct to corticosteroids. foradil should not be used in the treatment of acute asthmatic symptoms, or in patients whose asthma can be managed by occasional use of short-acting beta-2 agonists.

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - formoterol fumarate 12ug;   - powder for inhalation - 12 mcg/dose - active: formoterol fumarate 12ug   excipient: lactose monohydrate

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - formoterol fumarate 4.5ug (/dose for the m3 device. equivalent to 6 µg/dose of the m2 device.);   - powder for inhalation - 6 mcg/dose - active: formoterol fumarate 4.5ug (/dose for the m3 device. equivalent to 6 µg/dose of the m2 device.)   excipient: lactose monohydrate - oxis turbuhaler is indicated as add on therapy to maintenance treatment with inhaled corticosteroids for the treatment of broncho-obstructive symptoms and prevention of exercise-induced symptoms in adults and children six years of age and over with asthma when adequate treatment with corticosteroids is not sufficient. oxis turbuhaler should not be used in the treatment of acute asthmatic symptoms or in patients whose asthma can be managed by occasional use of short-acting beta-2 agonists.