European Union - English - 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.

European Union - English - EMA (European Medicines Agency)

teva pharma b.v. - budesonide, formoterol - asthma - drugs for obstructive airway diseases, - budesonide/formoterol teva pharma b.v. is indicated in adults 18 years of age and older only.asthmabudesonide/formoterol teva pharma b.v. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate: orin patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists. 

European Union - English - EMA (European Medicines Agency)

teva pharma b.v.  - budesonide, formoterol fumarate dihydrate - asthma; pulmonary disease, chronic obstructive - drugs for obstructive airway diseases, - budesonide/formoterol teva pharma b.v. is indicated in adults 18 years of age and older only.asthmabudesonide/formoterol teva pharma b.v. 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.or-in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.copdsymptomatic treatment of patients with copd with forced expiratory volume in 1 second (fev1) 

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)

astrazeneca pty ltd - formoterol fumarate dihydrate, quantity: 4.5 microgram/actuation - inhalation, powder for - excipient ingredients: lactose monohydrate - long-term treatment of reversible airways obstruction in asthma (including nocturnal asthma and exercise induced asthma) in adults and children aged 12 years and over and who are receiving inhaled or oral corticosteroids and who require bronchodilator therapy.,oxis turbuhaler can be used on demand (prn) in asthmatics over the age of 18 years who are receiving inhaled or oral corticosteroids. it should not be used in patients whose asthma can be managed alone by occasional use of short acting inhaled beta-2 agonists.

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

astrazeneca pty ltd - formoterol fumarate dihydrate, quantity: 9 microgram/actuation - inhalation, powder for - excipient ingredients: lactose monohydrate - long-term treatment of reversible airways obstruction in asthma (including nocturnal asthma and exercise induced asthma) in adults and children aged 12 years and over and who are receiving inhaled or oral corticosteroids and who require bronchodilator therapy.,oxis turbuhaler can be used on demand (prn) in asthmatics over the age of 18 years who are receiving inhaled or oral corticosteroids. it should not be used in patients whose asthma can be managed alone by occasional use of short acting inhaled beta-2 agonists.

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

alembic pharmaceuticals inc. - arformoterol tartrate (unii: 5p8vj2i235) (arformoterol - unii:f91h02ebwt) - arformoterol tartrate inhalation solution is indicated for the long-term, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (copd), including chronic bronchitis and emphysema. arformoterol tartrate inhalation solution is for use by nebulization only. arformoterol tartrate inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see warnings and precautions (5.2) ]. arformoterol tartrate inhalation solution is not indicated to treat asthma. the safety and effectiveness of arformoterol tartrate inhalation solution in asthma have not been established. arformoterol tartrate inhalation solution is contraindicated in patients with a history of hypersensitivity to arformoterol, racemic formoterol or to any other components of this product. use of a laba, including arformoterol tartrate inhalation solution, without an inhaled cortisteroid is contraindicated in patients with asthma [see warnings and precautions (5) ]. arformoterol tartrate inhalation solution is not indicated for the treatment of asthma. risk summary there are no adequate and well-controlled studies in pregnant women. arformoterol tartrate should only be used during pregnancy if the expected benefit to the patient outweighs the potential risk to the fetus. women should be advised to contact their physician if they become pregnant while taking arformoterol tartrate. in animal reproduction studies with arformoterol administered by the oral route to rats and rabbits at exposures approximately 370 and 8,400 times the adult exposure at the maximum recommended human daily inhalation dose (mrhdid) of 15 mcg every 12 hours, respectively, there were findings of structural abnormalities, embryofetal and infant mortality, and alterations of growth. these adverse effects generally occurred at large multiples of the mrhdid when arformoterol was administered by the oral route to achieve high systemic exposures. no evidence of fetal harm was observed in rabbits at an exposure approximately 4,900 times the mrhdid. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations labor or delivery : the potential effect of arformoterol tartrate on labor and delivery is unknown. because of the potential for beta-agonists interference with uterine contractility, use of arformoterol tartrate inhalation solution during labor should be restricted to whom the benefits clearly outweigh the risk. data animal data in an embryofetal development study in which pregnant rats received doses of 1,000, 5,000 or 10,000 mcg/kg/day from gestation days 6 to 17, arformoterol was shown to be teratogenic based upon findings of omphalocele (umbilical hernia), a malformation, in rat fetuses at exposures approximately 370 times adult exposure at the mrhdid (on an auc basis with maternal oral doses of 1,000 mcg/kg/day and higher. maternal toxicity was not observed in rats with exposures up to 2,400 times the mrhdid (on an auc basis with maternal oral doses up to 10,000 mcg/kg/day). a no-observed-adverse-effect-level (noael) for rat fetuses was not identified. in an embryofetal development study in which pregnant rabbits received doses of 20,000, 40,000 or 80,000 mcg/kg/day from gestation days 7 to 20, arformoterol was shown to be teratogenic based upon findings of malpositioned right kidney, a malformation, in rabbit fetuses at exposures approximately 8400 times and higher than the adult exposure at the mrhdid (on an auc basis with maternal oral doses of 20,000 mcg/kg/day and higher). malformations including brachydactyly, bulbous aorta, and liver cysts as well as decreased body weights were observed in rabbit fetuses at doses approximately 26,000 times and higher than the mrhdid in adults (on a mcg/m2 basis with maternal oral doses of 40,000 mcg/kg/day and higher). malformations including adactyly, lobular dysgenesis of the lung, and interventricular septal defect as well as embryolethality were observed in rabbit fetuses at a dose approximately 52,000 times the mrhdid in adults (on a mcg/m2 basis with a maternal oral dose of 80,000 mcg/kg/day). maternal toxicity was observed at doses approximately 26,000 times and higher than the mrhdid in adults (on a mcg/m2 basis with maternal oral doses of 40,000 mcg/kg/day and higher). there was no evidence of fetal harm in rabbits at exposures approximately 4,900 times and lower than the adult exposure at the mrhdid (on an auc basis with maternal oral doses of 10,000 mcg/kg/day and lower). in a pre-and post-natal development study, female rats received arformoterol at oral doses of 0, 1,000, 5,000, and 10,000 mcg/kg/day from gestation day 6 through lactation day 20. lengths of gestation for female rats receiving doses 325 times and higher than the mrhdid (on a mcg/m2 basis with maternal oral doses of 1,000 mcg/kg/day and higher) were slightly prolonged, which was attributed to prolonged parturition or dystocia due to the pharmacological action of β-adrenergic agonists such as arformoterol to relax uterine musculature. one female that had received a dose 3,200 times the mrhdid (on a mcg/m2 basis with a maternal oral dose of 10,000 mcg/kg/day) was euthanized due to complications during parturition. pup survival and body weights were decreased at doses 1,600 times and higher than the mrhdid (on a mcg/m2 basis with maternal oral doses of 5,000 mcg/kg/day and higher) at birth and during lactation. umbilical hernia, a malformation, was observed for 1 pup at a dose 3,200 times the mrhdid (on a mcg/m2 basis with a maternal oral dose of 10,000 mcg/kg/day). potential developmental delays of rat pups were observed at a dose 3,200 times the mrhdid (on a mcg/m2 basis with a maternal oral dose of 10,000 mcg/kg/day); however, no developmental delays were evident with doses 1,600 times the mrhdid (on a mcg/m2 basis with a maternal oral dose of 5,000 mcg/kg/day). risk summary there are no data on the presence of arformoterol or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. however, arformoterol was excreted in the milk of lactating rats. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for arformoterol tartrate and any potential adverse effects on the breastfed infant from arformoterol tartrate or from the underlying maternal condition. data arformoterol and its metabolites were detected in the milk of lactating rats following oral administration of a 10,000 mcg/kg dose of radiolabeled arformoterol tartrate. arformoterol tartrate inhalation solution is approved for use in the long-term maintenance treatment of bronchoconstriction associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema. this disease does not occur in children. the safety and efficacy of arformoterol tartrate inhalation solution in pediatric patients have not been established. of the 873 patients who received arformoterol tartrate inhalation solutionin two placebo-controlled clinical studies in adults with copd, 391 (45%) were 65 years of age or older while 96 (11%) were 75 years of age or older. no overall differences in safety or effectiveness were observed between these subjects and younger subjects. among subjects age 65 years and older, 129 (33%) received arformoterol tartrate inhalation solution at the recommended dose of 15 mcg twice daily, while the remainder received higher doses. ecg alerts for ventricular ectopy in patients 65 to ≤75 years of age were comparable among patients receiving 15 mcg twice daily, 25 mcg twice daily, and placebo (3.9%, 5.2%, and 7.1%, respectively). a higher frequency (12.4%) was observed when arformoterol tartrate inhalation solution was dosed at 50 mcg once daily. the clinical significance of this finding is not known. other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. arformoterol tartrate inhalation solution should be used cautiously in patients with hepatic impairment due to increased systemic exposure in these patients [see clinical pharmacology (12.3) ]. the systemic exposure to arformoterol was similar to renally impaired patients compared with demographically matched healthy control subjects [see clinical pharmacology (12.3) ]. there were no reported cases of abuse or evidence of drug dependence with the use of arformoterol tartrate inhalation solution in the clinical trials.