USA - engelsk - NLM (National Library of Medicine)

american health packaging - 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 to 4% and 15 to 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/m 2 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/m 2 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/m 2 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/m 2 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/m 2 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/m 2 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/m 2 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/m 2 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/m 2 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 solution in 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. 8477083/0523f instructions for using arformoterol tartrate inhalation solution arformoterol tartrate inhalation solution is used only in a standard jet nebulizer machine connected to an air compressor. make sure you know how to use your nebulizer machine before you use it to breathe in arformoterol tartrate inhalation solution or other medicines. do not mix arformoterol tartrate inhalation solution with other medicines in your nebulizer machine. arformoterol tartrate inhalation solution comes sealed in a foil pouch. do not open a sealed pouch until you are ready to use a dose of arformoterol tartrate inhalation solution. an opened unit-dose vial should be used right away. 1. open the foil pouch and remove the unit-dose vial of arformoterol tartrate inhalation solution. 2. carefully twist open the top of the unit-dose vial and use it right away (figure 1). 3. squeeze all of the medicine from the unit-dose vial into the nebulizer medicine cup (reservoir) (figure 2). 4. connect the nebulizer reservoir to the mouthpiece (figure 3) or face mask (figure 4). 5. connect the nebulizer to the compressor (figure 5). 6. sit in a comfortable, upright position. place the mouthpiece in your mouth (figure 6) (or put on the face mask) and turn on the compressor. 7. breathe as calmly, deeply, and evenly as possible until no more mist is formed in the nebulizer reservoir. it takes about 5 to 10 minutes for each treatment. 8. clean the nebulizer (see manufacturer’s instructions). rx only this instructions for use has been approved by the food and drug administration. dispense with patient information. to order more patient information sheets call american health packaging at 1‐800‐707‐4621. distributed by: american health packaging columbus, oh 43217 8477083/0523f

Den europeiske union - engelsk - 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.

Den europeiske union - engelsk - 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. 

USA - engelsk - 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

Storbritannia - engelsk - MHRA (Medicines & Healthcare Products Regulatory Agency)

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

Den europeiske union - engelsk - 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) 

USA - engelsk - NLM (National Library of Medicine)

lifestar pharma llc - 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. there are limited available data with formoterol fumarate inhalation solution use in pregnant women to inform a drug-associated

USA - engelsk - NLM (National Library of Medicine)

lupin 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 asthm

Canada - engelsk - Health Canada

astrazeneca canada inc - formoterol fumarate dihydrate; glycopyrronium (glycopyrronium bromide) - aerosol, metered dose - 5.8mcg; 8.3mcg - formoterol fumarate dihydrate 5.8mcg; glycopyrronium (glycopyrronium bromide) 8.3mcg - antimuscarinics antispasmodics

Irland - engelsk - HPRA (Health Products Regulatory Authority)

mylan ire healthcare limited - formoterol fumatrate dihydrate - powder for inhalation - 6 microgram(s) - selective beta-2-adrenoreceptor agonists; formoterol