Ireland - English - HPRA (Health Products Regulatory Authority)

rowex ltd - budesonide; formoterol fumarate dihydrate - inhalation powder, pre-dispensed - 320/9 microgram(s) - formoterol and budesonide

Malta - English - Medicines Authority

astrazeneca ab se-151 85, södertälje, sweden - budesonide, formoterol fumarate, dihydrate - pressurised inhalation, suspension - budesonide 80 µg formoterol fumarate dihydrate 2.25 µg - drugs for obstructive airway diseases

Ireland - English - HPRA (Health Products Regulatory Authority)

merit pharmaceuticals limited - budesonide; formoterol fumarate dihydrate - inhalation powder - 200 µg/6 µg/inhalation - formoterol and budesonide

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

physicians total care, inc. - formoterol fumarate (unii: p3t5qa5j9n) (formoterol - unii:5zz84gcw8b) - formoterol fumarate 12 ug - foradil aerolizer is indicated for the treatment of asthma and in the prevention of bronchospasm only as concomitant therapy with a long-term asthma control medication, such as an inhaled corticosteroid, in adults and children 5 years of age and older with reversible obstructive airways disease, including patients with symptoms of nocturnal asthma.       long-acting beta2 -adrenergic agonists (laba), such as formoterol, the active ingredient in foradil aerolizer, increase the risk of asthma-related death (see warnings). use of foradil aerolizer for the treatment of asthma without concomitant use of a long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated. use foradil aerolizer only as additional therapy for patients with asthma who are currently taking but are inadequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid. once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g

Ireland - English - HPRA (Health Products Regulatory Authority)

orion corporation - budesonide; formoterol fumarate dihydrate - inhalation powder - 80/4.5 microgram(s) - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and budesonide

Ireland - English - HPRA (Health Products Regulatory Authority)

orion corporation - budesonide; formoterol fumarate dihydrate - inhalation powder - 160/4.5 microgram(s) - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and budesonide

Ireland - English - HPRA (Health Products Regulatory Authority)

orion corporation - budesonide; formoterol fumarate dihydrate - inhalation powder - 320/9 microgram(s) - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and budesonide

Ireland - English - HPRA (Health Products Regulatory Authority)

imed healthcare ltd. - formoterol fumarate dihydrate; budesonide - inhalation powder - 400 µg /12 µg/inhalation - adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and budesonide - adrenergics and other drugs for obstructive airway diseases. - it is indicated: in adults and adolescents aged 12 to 17 years for the regular treatment of asthma where use of a combination is appropriate; in adults, aged 18 years and older, for the symptomatic treatment of patients with severe copd and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators

Israel - English - Ministry of Health

astrazeneca (israel) ltd - budesonide; formoterol fumarate dihydrate; glycopyrronium - suspension for inhalation - formoterol fumarate dihydrate 5 mcg; glycopyrronium 7.2 mcg; budesonide 160 mcg - budesonide - 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

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

alembic pharmaceuticals inc. - formoterol fumarate (unii: w34shf8j2k) (formoterol - unii:5zz84gcw8b) - 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  formoterol fumarate inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease [see warnings and precautions (5.2) ].  formoterol fumarate inhalation solution is not indicated to treat asthma. the safety and effectiveness of formoterol fumarate inhalation solution in asthma have not been established. use of a laba, including formoterol fumarate inhalation solution, without an inhaled corticosteroid is contraindicated in patients with asthma [see warnings and precautions (5.1) ]. formoterol fumarate inhalation solution is not indicated for the treatment of asthma. risk summary there are limited available data with formoterol fumarate inhalation solution use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. beta-agonists may interfere with uterine contractility (see clinical considerations). in animal reproduction studies, oral administration of formoterol fumarate to pregnant rats and rabbits caused increased fetal malformations (rats and rabbits), decreased fetal weight (rats), and increased neonatal mortality (rats) following administration of doses that produced exposures approximately 730 to 29,000 times the mrhd on a mg/m2 or auc basis. these adverse effects generally occurred at large multiples of the mrhd when formoterol fumarate was administered by the oral route to achieve high systemic exposures. no effects were observed in a study with rats that received formoterol fumarate by the inhalation route at an exposure approximately 300 times the mrhd (see data). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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 there are no adequate and well-controlled human studies that have studied the effects of formoterol fumarate inhalation solution during labor and delivery. because of the potential for beta-agonists interference with uterine contractility, use of formoterol fumarate inhalation solution during labor should be restricted to those patients in whom the benefits clearly outweigh the risk.   data animal data in embryofetal development studies with pregnant rats and rabbits dosed throughout the period of organogenesis, formoterol fumarate did not cause malformations in either species. however, for pregnant rats dosed throughout organogenesis, formoterol fumarate caused delayed fetal ossification at an exposure approximately 50 times the mrhd (on a mcg/m2 basis with maternal oral doses of 200 mcg/kg and higher) and decreased fetal weight at an exposure approximately 1,500 times the mrhd (on a mcg/m2 basis with maternal oral doses of 6,000 mcg/kg and above). in a pre-and post-natal development study with rats dosed during the late stage of pregnancy, formoterol fumarate caused stillbirth and neonatal mortality at an exposure approximately 1,500 times the mrhd (on a mcg/m2 basis with maternal oral doses of 6,000 mcg/kg and above). however, no effects were observed in this study at an exposure approximately 50 times the mrhd (on a mcg/m2 basis with a maternal oral dose of 200 mcg/kg). in embryofetal development studies, conducted by another testing laboratory, with pregnant rats and rabbits dosed throughout the period of organogenesis, formoterol fumarate was teratogenic in both species. umbilical hernia, a malformation, was observed in rat fetuses at exposures approximately 730 times the mrhd (on a mcg/m2 basis with maternal oral doses of 3,000 mcg/kg/day and above). brachygnathia, a skeletal malformation, was observed in rat fetuses at an exposure approximately 3,600 times the mrhd (on a mcg/m2 basis with a maternal oral dose of 15,000 mcg/kg/day). in another study with rats, no teratogenic effects were observed with exposures up to approximately 300 times the mrhd (on a mcg/m2 basis with a maternal inhalation dose of 1,200 mcg/kg/day). subcapsular cysts on the liver were observed in rabbit fetuses at an exposure approximately 29,000 times the mrhd (on a mcg/m2 basis with a maternal oral dose of 60,000 mcg/kg/day). no teratogenic effects were observed with exposures up to approximately 1,700 times the mrhd (on a mcg/m2 basis with a maternal oral dose of 3,500 mcg/kg). risk summary there are no well-controlled human studies of the use of formoterol fumarate inhalation solution in nursing mothers. it is not known whether formoterol fumarate is excreted in human milk, or whether there are effects on the breastfed infant or on the milk production. in reproductive studies in rats formoterol was excreted in the milk (see data ). the developmental and health benefits of breastfeeding should be considered along with the mother`s clinical need for formoterol fumarate inhalation solution and any potential adverse effects on the breastfed child fromformoterol fumarate inhalation solution or from the underlying maternal condition. data in a pharmacokinetic study in rats formoterol was excreted in the milk. the amount of radioactive labeled 3h-formoterol fumarate was less than 2% of that in the maternal plasma. formoterol fumarate inhalation solution is not indicated for use in children. the safety and effectiveness of formoterol fumarate inhalation solution in pediatric patients have not been established. the pharmacokinetics of formoterol fumarate has not been studied in pediatric patients. of the 586 subjects who received formoterol fumarate inhalation solution in clinical studies, 284 were 65 years and over, while 89 were 75 years and over. of the 123 subjects who received formoterol fumarate inhalation solution in the 12-week safety and efficacy trial, 48 (39%) were 65 years of age or older. no overall differences in safety or effectiveness were observed between these subjects and younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger adult patients, but greater sensitivity of some older individuals cannot be ruled out. the pharmacokinetics of formoterol fumarate inhalation solution has not been studied in elderly subjects.