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

covis pharma us, inc - 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 administration of aclidinium bromide to pregnant rats and rabbits during organogenesis at 15 or 20 times, respectively, the maximum recommended human daily inhaled dose (mrhdid). however, reduced pup weights were seen when pregnant rats continued inhalation administration through lactation at 5 times the mrhdid of aclidinium bromide. adverse developmental effects occurred when rabbits were orally dosed with aclidinium bromide at approximately 1,400 times the mrhdid [see data] . formoterol fumarate alone, administered by the oral route, was teratogenic in rats and rabbits at 1,200 and 49,000 times the mrhdid, respectively. formoterol fumarate was also embryocidal, increased pup loss at birth and during lactation, and decreased pup weight in rats at 85 times the mrhdid. these adverse effects generally occurred at large multiples of the mrhdid when formoterol fumarate was administered by the oral route to achieve high systemic exposures. no teratogenic, embryocidal, or developmental effects were seen in rats that received inhalation doses up to 280 times the mrhdid [see data ]. the estimated background risk of major birth defects and miscarriage of the indicated populations 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 there are no well-controlled human studies that have investigated the effects of duaklir pressair during labor and delivery. because of the potential for beta-agonist interference with uterine contractility, use of duaklir pressair during labor should be restricted to those patients in whom the benefits clearly outweigh the risk. data animal data aclidinium bromide in an embryo-fetal development study in pregnant rats dosed during the period of organogenesis from gestation days 6-17, no evidence of structural alterations was observed at approximately 15 times the maximum recommended human daily inhaled dose (mrhdid) [based on summed aucs of aclidinium bromide and its metabolites at inhaled doses less than or equal to 5.0 mg/kg/day]. however, in a pre- and post-natal development study, decreased pup weights were observed when pregnant rats were exposed from gestation day 6 and continuing during the lactation period at approximately 5 times the mrhdid [based on summed aucs of aclidinium bromide and its metabolites at inhaled doses greater than or equal to 0.2 mg/kg/day]. maternal toxicity was also observed at inhaled doses greater than or equal to 0.2 mg/kg/day. in an embryo-fetal development study in pregnant himalayan rabbits administered inhaled doses of aclidinium bromide during the period of organogenesis from gestation days 6-19, no evidence of structural alterations was observed at approximately 20 times the mrhdid [based on summed aucs of aclidinium bromide and its metabolites at inhaled doses less than or equal to 3.6 mg/kg/day]. however, in another embryo-fetal development study in pregnant himalayan rabbits dosed orally from gestation days 6-19, increased incidences of additional liver lobes (3-5%), as compared to 0% in the control group, were observed at approximately 1,400 times the mrhdid [based on summed aucs of aclidinium bromide and its metabolites at oral doses greater than or equal to 150 mg/kg/day], and decreased fetal body weights were observed at approximately 2,300 times the mrhdid [based on summed aucs of aclidinium bromide and its metabolites at oral doses greater than or equal to 300 mg/kg/day]. these fetal findings were observed in the presence of maternal toxicity. formoterol fumarate in a fertility and reproduction study, male rats were orally dosed for 9 weeks and females for 2 weeks prior to pairing and throughout the mating period. females were either dosed up to gestation day 19 or up until weaning of their offspring. males were dosed up to 25 weeks. umbilical hernia was observed in rat fetuses at oral doses 1,200 times and greater than the mrhdid (on a mg/m2 basis at maternal oral doses of 3 mg/kg/day and higher). brachygnathia, abnormal shortness of the mandible, was observed in rat fetuses at a dose 6,000 times the mrhdid (on a mg/m2 basis at a maternal oral dose of 15 mg/kg/day). pregnancy was prolonged at a dose 6,000 times the mrhdid (on a mg/m2 basis at a maternal oral dose of 15 mg/kg/day). fetal and pup deaths occurred at doses approximately 1,200 times the mrhdid and higher (on a mg/m2 basis at oral doses of 3 mg/kg/day and higher) during gestation. in an embryo-fetal development study in pregnant rats dosed during the period of organogenesis from gestation days 6-15, no teratogenic, embryocidal or developmental effects were seen at doses up to 280 times the mrhdid (on a mg/m2 basis with maternal inhalation doses up to 0.69 mg/kg/day). in an embryo-fetal development study in pregnant rabbits dosed during the period of organogenesis from gestation days 6-18, subcapsular cysts on the liver were observed in the fetuses at a dose 49,000 times the mrhdid (on a mg/m2 basis with a maternal oral dose of 60 mg/kg/day). no teratogenic effects were observed at doses up to 2,800 times the mrhdid (on a mg/m2 basis at maternal oral doses up to 3.5 mg/kg/day). in a pre- and post-natal development study, pregnant female rats received formoterol at oral doses of 0, 0.21, 0.84, and 3.4 mg/kg/day from gestation day 6 through the lactation period. pup survival was decreased from birth to postpartum day 26 at doses 85 times the mrhdid and higher (on a mg/m2 basis at maternal oral doses of 0.21 mg/kg/day and higher), although there was no evidence of a dose-response relationship. there were no treatment-related effects on the physical, functional, and behavioral development of rat pups. risk summary there are no available data on the effects of duaklir pressair, aclidinium bromide, or formoterol fumarate on the breastfed child or on milk production or presence in human milk. both aclidinium bromide and formoterol fumarate are present in rat milk [see data]. when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for duaklir pressair and any potential adverse effects on the breastfed child from duaklir pressair or from the underlying maternal condition. data in a pharmacokinetic study, levels of radioactivity in milk and plasma in rats were measured after a single intravenous dose of 1 mg/kg of radiolabeled aclidinium bromide on approximately post-natal day 14 [see use in specific populations (8.1)] . the maximum concentration of radioactivity [14 c aclidinium] in milk was measured at 6 hours post-dose and was found to be 10-14 times higher than in plasma. in the fertility and reproduction study in rats, plasma levels of formoterol were measured in pups on post-natal day 15 [see use in specific populations (8.1)] . it was estimated that the maximum plasma concentration that the pups received from the maternal animal, at the highest dose of 15 mg/kg, after nursing was 4.4% (0.24 nmol/l for a litter vs. 5.5 nmol/l for the mother). duaklir pressair is not indicated for use in children. the safety and effectiveness of duaklir pressair in the pediatric population have not been established. based on available data for duaklir pressair or its active components, no adjustment of dosage in geriatric patients is warranted [see clinical pharmacology (12.3)] . of the 720 copd patients exposed to duaklir pressair for 24 weeks in two placebo-controlled clinical trials, 238 were less than 60 years, 301 were greater than or equal to 60 to less than 70 years, and 181 were greater than or equal to 70 years of age. 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 patients, but greater sensitivity of some older individuals cannot be ruled out. formal pharmacokinetic studies using duaklir pressair have not been conducted in patients with hepatic impairment. based on available data for aclidinium and formoterol, no adjustment of dosage in hepatically impaired subjects is warranted. formal pharmacokinetic studies using duaklir pressair have not been conducted in patients with renal impairment. based on available data for aclidinium and formoterol, no adjustment of dosage in renally impaired subjects is warranted.

Nieuw-Zeeland - Engels - Medsafe (Medicines Safety Authority)

viatris limited - formoterol fumarate 0.42%{relative} ((micronised)) - powder for inhalation - 12 mcg - active: formoterol fumarate 0.42%{relative} ((micronised)) excipient: lactose monohydrate

Kenia - Engels - Pharmacy and Poisons Board

bliss gvs pharma limited 102, hyde park, saki vihar road, andheri (east) - - formoterol fumarate dihydrate bp and budesonide bp - pressurised inhalation - formoterol fumarate dihydrate bp equivalent to… - formoterol and budesonide

Kenia - Engels - Pharmacy and Poisons Board

bliss gvs pharma limited 102, hyde park, saki-vihar road, andheri (east), - formoterol fumarate dihydrate bp and budesonide bp - pressurised inhalation - formoterol fumarate dihydrate bp equivalent to… - formoterol and budesonide

Nieuw-Zeeland - Engels - Medsafe (Medicines Safety Authority)

astrazeneca limited - formoterol fumarate 12ug;   - powder for inhalation - 12 mcg/dose - active: formoterol fumarate 12ug   excipient: lactose monohydrate

Nieuw-Zeeland - Engels - Medsafe (Medicines Safety Authority)

astrazeneca limited - formoterol fumarate 4.5ug (/dose for the m3 device. equivalent to 6 µg/dose of the m2 device.);   - powder for inhalation - 6 mcg/dose - active: formoterol fumarate 4.5ug (/dose for the m3 device. equivalent to 6 µg/dose of the m2 device.)   excipient: lactose monohydrate - oxis turbuhaler is indicated as add on therapy to maintenance treatment with inhaled corticosteroids for the treatment of broncho-obstructive symptoms and prevention of exercise-induced symptoms in adults and children six years of age and over with asthma when adequate treatment with corticosteroids is not sufficient. oxis turbuhaler should not be used in the treatment of acute asthmatic symptoms or in patients whose asthma can be managed by occasional use of short-acting beta-2 agonists.

Singapore - Engels - HSA (Health Sciences Authority)

novartis (singapore) pte ltd - formoterol fumarate - powder, metered - 12 mcg/capsule - formoterol fumarate 12 mcg/capsule

Nieuw-Zeeland - Engels - Medsafe (Medicines Safety Authority)

sandoz new zealand limited - formoterol fumarate 12ug - powder filled inhalation capsule - 12 mcg - active: formoterol fumarate 12ug excipient: gelatin ink lactose monohydrate - foradil is indicated for the treatment of bronchoconstriction in adults and children six years of age and over with asthma as an add-on to inhaled corticosteroid (ics) treatment. in the management of asthma, foradil should be used only as an adjunct to corticosteroids. foradil should not be used in the treatment of acute asthmatic symptoms, or in patients whose asthma can be managed by occasional use of short-acting beta-2 agonists.

Israël - Engels - Ministry of Health

kamada ltd, israel - beclometasone dipropionate; formoterol fumarate dihydrate; glycopyrronium as bromide - pressurised solution - glycopyrronium as bromide 9 mcg/delivered dose; formoterol fumarate dihydrate 5.2 mcg/delivered dose; beclometasone dipropionate 87.4 mcg/delivered dose - formoterol, glycopyrronium bromide and beclometasone - copd 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 a combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist. asthma maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and medium dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year.…

Israël - Engels - Ministry of Health

teva pharmaceutical industries ltd, israel - formoterol fumarate - powder for inhalation - formoterol fumarate 9 mcg/dose - formoterol - formoterol - for the relief of broncho-obstructive symptoms and prevention of exercise-induced symptoms in asthmatics when adequate treatment with corticosteroids is not sufficient. for the relief of bronco-obstructive symptoms in patients with chronic obstructive pulmonary disease (copd).