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

teva pharma australia pty ltd - budesonide, quantity: 320 microgram; formoterol fumarate dihydrate, quantity: 9 microgram - inhalation, powder for - excipient ingredients: lactose monohydrate - asthma: duoresp spiromax is indicated in adults (18 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).,duoresp spiromax is not indicated in children and adolescents under the age of 18 years as the 100/6 dose is not available.,chronic obstructive pulmonary disease (copd): duoresp spiromax is indicated for the symptomatic treatment of moderate to severe copd (fev1=50% predicted normal) in adults with frequent symptoms despite long-acting bronchodilator use, and/or history of recurrent exacerbations. duoresp spiromax is not indicated for the initiation of bronchodilator therapy in copd.

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

teva pharma australia pty ltd - budesonide, quantity: 160 microgram; formoterol fumarate dihydrate, quantity: 4.5 microgram - inhalation, powder for - excipient ingredients: lactose monohydrate - asthma: duoresp spiromax is indicated in adults (18 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).,duoresp spiromax is not indicated in children and adolescents under the age of 18 years as the 100/6 dose is not available.,chronic obstructive pulmonary disease (copd): duoresp spiromax is indicated for the symptomatic treatment of moderate to severe copd (fev1=50% predicted normal) in adults with frequent symptoms despite long-acting bronchodilator use, and/or history of recurrent exacerbations. duoresp spiromax is not indicated for the initiation of bronchodilator therapy in copd.

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

teva pharma australia pty ltd - budesonide, quantity: 320 microgram; formoterol fumarate dihydrate, quantity: 9 microgram - inhalation, powder for - excipient ingredients: lactose monohydrate - asthma: biresp spiromax is indicated in adults (18 years and older) for the treatment of asthma, to achieve overall asthma control, including the relief of symptoms and the reduction of the risk and exacerbations (see section 4.2 dose and method of administration).,biresp spiromax is not indicated in children and adolescents under the age of 18 years as the 100/6 dose is not available.,chronic obstructive pulmonary disease (copd): biresp spiromax is indicated for the symptomatic treatment of moderate to severe copd (fev1=50% predicted normal) in adults with frequent symptoms despite long-acting bronchodilator use, and/or history of recurrent exacerbations. biresp spiromax is not indicated for the initiation of bronchodilator therapy in copd.

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

teva pharma australia pty ltd - budesonide, quantity: 160 microgram; formoterol fumarate dihydrate, quantity: 4.5 microgram - inhalation, powder for - excipient ingredients: lactose monohydrate - asthma: biresp spiromax is indicated in adults (18 years and older) for the treatment of asthma, to achieve overall asthma control, including the relief of symptoms and the reduction of the risk and exacerbations (see section 4.2 dose and method of administration).,biresp spiromax is not indicated in children and adolescents under the age of 18 years as the 100/6 dose is not available.,chronic obstructive pulmonary disease (copd): biresp spiromax is indicated for the symptomatic treatment of moderate to severe copd (fev1=50% predicted normal) in adults with frequent symptoms despite long-acting bronchodilator use, and/or history of recurrent exacerbations. biresp spiromax is not indicated for the initiation of bronchodilator therapy in copd.

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

a menarini australia pty ltd - aclidinium bromide, quantity: 0.4 mg/actuation; formoterol fumarate dihydrate, quantity: 0.012 mg/actuation - inhalation, powder for - excipient ingredients: lactose monohydrate - brimica genuair 340/12 is indicated as a long-term twice daily maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (copd).

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

astrazeneca pty ltd - formoterol fumarate dihydrate, quantity: 2.25 microgram; budesonide, quantity: 40 microgram - inhalation, pressurised - excipient ingredients: apaflurane; macrogol 1000; povidone - 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.

United States - English - NLM (National Library of Medicine)

mylan specialty l.p. - formoterol fumarate (unii: w34shf8j2k) (formoterol - unii:5zz84gcw8b) - formoterol fumarate anhydrous 20 ug in 2 ml - perforomist (formoterol fumarate) inhalation solution is indicated for the long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (copd), including chronic bronchitis and emphysema. perforomist inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see warnings and precautions (5.2)]. perforomist inhalation solution is not indicated to treat asthma. the safety and effectiveness of perforomist inhalation solution in asthma have not been established. use of a laba, including perforomist, without an inhaled corticosteroid is contraindicated in patients with asthma [see warnings and precautions (5.1)] . perforomist is not indicated for the treatment of asthma. there are limited available data with perforomist inhalation solution use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. beta-agonists may interfere w

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 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.

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 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.

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.