Australië - Engels - 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.

Australië - Engels - 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.

Australië - Engels - 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).

Europese Unie - Engels - EMA (European Medicines Agency)

teva pharma b.v. - budesonide, formoterol fumarate dihydrate - pulmonary disease, chronic obstructive; asthma - drugs for obstructive airway diseases, - budesonide/formoterol teva is indicated in adults 18 years of age and older only.asthmabudesonide/formoterol teva is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate:in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.orin patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.copdsymptomatic treatment of patients with severe copd (fev1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

chiesi australia pty ltd - beclometasone dipropionate, quantity: 100 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). copd (fostair 100/6 only) symptomatic treatment of adults with severe copd (fev1 less than 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.

Verenigde Staten - Engels - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x), formoterol fumarate (unii: w34shf8j2k) (formoterol - unii:5zz84gcw8b) - breyna is indicated for the treatment of asthma in patients 6 years of age and older. breyna should be used for patients not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid (ics) or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long-acting beta2 -adrenergic agonist (laba). important limitations of use: breyna 160 mcg/4.5 mcg is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (copd) including chronic bronchitis and/or emphysema. breyna 160 mcg/4.5 mcg is also indicated to reduce exacerbations of copd. breyna 160 mcg/4.5 mcg is the only strength indicated for the treatment of copd. important limitations of use: the use of breyna is contraindicated in the following conditions: there are no adequate and well-controlled studies of budesonide and formoterol fumarate dihydrate inhalation aerosol or one of its individual components, formoterol fumarate, in pre

Verenigde Staten - Engels - NLM (National Library of Medicine)

astrazeneca pharmaceuticals lp - glycopyrrolate (unii: v92so9wp2i) (glycopyrronium - unii:a14fb57v1d), formoterol fumarate (unii: w34shf8j2k) (formoterol - unii:5zz84gcw8b) - glycopyrrolate 9 ug - bevespi aerosphere is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (copd). limitations of use: bevespi aerosphere is not indicated for the relief of acute bronchospasm or for the treatment of asthma [see warnings and precautions (5.1, 5.2)] . bevespi aerosphere is contraindicated in: risk summary   there are no adequate and well-controlled trials of bevespi aerosphere or its individual components, glycopyrrolate and formoterol fumarate, in pregnant women to inform a drug-associated risk. in animal reproduction studies, glycopyrrolate alone, administered by the subcutaneous route in rats and rabbits, did not cause structural abnormalities or affect fetal survival at exposures approximately 2700 and 5400 times from the maximum recommended human daily inhalation dose (mrhdid), respectively. glycopyrrolate had no effects on the physical, functional, and behavioral development of rat pups with exposures up to 2700 times the mrhdid. formoterol fumarate alone, admin

Verenigd Koninkrijk - Engels - MHRA (Medicines & Healthcare Products Regulatory Agency)

orion pharma (uk - formoterol fumarate dihydrate - inhalation powder - 12microgram/1dose

Verenigde Staten - Engels - NLM (National Library of Medicine)

astrazeneca pharmaceuticals lp - aclidinium bromide (unii: uqw7uf9n91) (aclidinium - unii:k17vy42f6c), formoterol fumarate (unii: w34shf8j2k) (formoterol - unii:5zz84gcw8b) - duaklir pressair is a combination of aclidinium bromide (an anticholinergic) and formoterol fumarate (a laba) indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (copd). limitations of use: duaklir pressair is not indicated for the relief of acute bronchospasm or for the treatment of asthma [see warnings and precautions (5.1, 5.4)] . use of a long-acting beta2 -adrenergic agonist (laba), including formoterol fumarate, one of the active ingredients in duaklir pressair, without an inhaled corticosteroid is contraindicated in patients with asthma [see warnings and precautions (5.1)] . duaklir pressair is not indicated for the treatment of asthma. duaklir pressair is contraindicated in patients with: risk summary there are no adequate and well-controlled studies of duaklir pressair or its individual components, formoterol fumarate or aclidinium bromide, in pregnant women to inform drug-associated risks. no adverse developmental effects were seen with inhalation administr

Australië - Engels - Department of Health (Therapeutic Goods Administration)

astrazeneca pty ltd - budesonide, quantity: 80 microgram; formoterol fumarate dihydrate, quantity: 4.5 microgram - inhalation, pressurised - excipient ingredients: povidone; macrogol 1000; apaflurane - asthma symbicort 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) symbicort 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. symbicort is not indicated for the initiation of bronchodilator therapy in copd.