USA - engelsk - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - tiotropium bromide monohydrate (unii: l64sxo195n) (tiotropium - unii:0eb439235f) - tiotropium bromide inhalation powder is indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (copd), including chronic bronchitis and emphysema. tiotropium bromide inhalation powder is indicated to reduce exacerbations in copd patients. tiotropium bromide inhalation powder is contraindicated in patients with a hypersensitivity to tiotropium, ipratropium, or any components of this product [see warnings and precautions (5.2)] . in clinical trials and postmarketing experience with tiotropium bromide inhalation powder, immediate hypersensitivity reactions, including angioedema (including swelling of the lips, tongue, or throat), itching, or rash have been reported [see warnings and precautions (5.2)] . risk summary the limited human data with tiotropium bromide inhalation powder use during pregnancy are insufficient to inform a drug-associated risk of adverse pregnancy-related outcomes. based on animal reproduction studies, no structural abnormalities were observed when tiotropium was administered by inhalation to pregnant rats and rabbits during the period of organogenesis at doses 790 and 8 times, respectively, the maximum recommended human daily inhalation dose (mrhdid). increased post-implantation loss was observed in rats and rabbits administered tiotropium at maternally toxic doses 430 times and 40 times the mrhdid, respectively [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% to 4% and 15% to 20%, respectively. data animal data in 2 separate embryo-fetal development studies, pregnant rats and rabbits received tiotropium during the period of organogenesis at doses up to approximately 790 and 8 times the mrhdid, respectively (on a mcg/m2 basis at inhalation doses of 1471 and 7 mcg/kg/day in rats and rabbits, respectively). no evidence of structural abnormalities was observed in rats or rabbits. however, in rats, tiotropium caused fetal resorption, litter loss, decreases in the number of live pups at birth and the mean pup weights, and a delay in pup sexual maturation at tiotropium doses of approximately 40 times the mrhdid (on a mcg/m2 basis at a maternal inhalation dose of 78 mcg/kg/day). in rabbits, tiotropium caused an increase in post-implantation loss at a tiotropium dose of approximately 430 times the mrhdid (on a mcg/m2 basis at a maternal inhalation dose of 400 mcg/kg/day). such effects were not observed at approximately 5 and 95 times the mrhdid, respectively (on a mcg/m2 basis at inhalation doses of 9 and 88 mcg/kg/day in rats and rabbits, respectively). risk summary there are no data on the presence of tiotropium in human milk, the effects on the breastfed infant, or the effects on milk production. tiotropium is present in milk of lactating rats; however, due to species-specific differences in lactation physiology, the clinical relevance of these data are not clear [see data] . the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tiotropium bromide inhalation powder and any potential adverse effects on the breastfed child from tiotropium bromide inhalation powder or from the underlying maternal condition. data the distribution of tiotropium bromide into milk was investigated after a single intravenous administration of 10 mg/kg to lactating rats. tiotropium and/or its metabolites are present in the milk of lactating rats at concentrations above those in plasma. tiotropium bromide inhalation powder is not indicated for use in children. the safety and effectiveness of tiotropium bromide inhalation powder in pediatric patients have not been established. based on available data, no adjustment of tiotropium bromide inhalation powder dosage in geriatric patients is warranted [see clinical pharmacology (12.3)]. of the total number of patients who received tiotropium bromide inhalation powder in the 1-year clinical trials, 426 were <65 years, 375 were 65 to 74 years, and 105 were ≥75 years of age. within each age subgroup, there were no differences between the proportion of patients with adverse events in the tiotropium bromide inhalation powder and the comparator groups for most events. dry mouth increased with age in the tiotropium bromide inhalation powder group (differences from placebo were 9.0%, 17.1%, and 16.2% in the aforementioned age subgroups). a higher frequency of constipation and urinary tract infections with increasing age was observed in the tiotropium bromide inhalation powder group in the placebo-controlled studies. the differences from placebo for constipation were 0%, 1.8%, and 7.8% for each of the age groups. the differences from placebo for urinary tract infections were –0.6%, 4.6%, and 4.5%. no overall differences in effectiveness were observed among these groups. patients with moderate to severe renal impairment (creatinine clearance of <60 ml/min) treated with tiotropium bromide inhalation powder should be monitored closely for anticholinergic side effects [see dosage and administration (2), warnings and precautions (5.6), and clinical pharmacology (12.3)] . the effects of hepatic impairment on the pharmacokinetics of tiotropium were not studied.

Belgia - nederlandsk - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

viatris gx bv-srl - tiotropiumbromide 21,67 µg - eq. tiotropium 18 µg - inhalatiepoeder in harde capsule - 18 µg - tiotropiumbromide 21.67 µg - tiotropium bromide

Belgia - nederlandsk - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

demo pharmaceutical industry s.a. - tiotropiumbromide 21,7 µg - eq. tiotropium 18 µg - inhalatiepoeder in harde capsule - 18 µg - tiotropiumbromide 21.7 µg - tiotropium bromide

USA - engelsk - NLM (National Library of Medicine)

boehringer ingelheim pharmaceuticals, inc. - tiotropium bromide anhydrous (unii: xx112xzp0j) (tiotropium - unii:0eb439235f) - tiotropium bromide 1.562 ug - spiriva respimat (tiotropium bromide) is indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (copd), including chronic bronchitis and emphysema. spiriva respimat is indicated to reduce exacerbations in copd patients. important limitation of use: spiriva respimat is not indicated for the relief of acute bronchospasm. spiriva respimat is a bronchodilator indicated for the long-term, once-daily, maintenance treatment of asthma in patients 6 years of age and older. important limitation of use: spiriva respimat is not indicated for the relief of acute bronchospasm. spiriva respimat is contraindicated in patients with a hypersensitivity to tiotropium, ipratropium, or any component of this product [see warnings and precautions (5.2)] . in clinical trials with spiriva respimat, immediate hypersensitivity reactions, including angioedema (including swelling of the lips, tongue, or throat), itching, or rash have been reported [see warning

USA - engelsk - NLM (National Library of Medicine)

physicians total care, inc. - tiotropium bromide monohydrate (unii: l64sxo195n) (tiotropium - unii:0eb439235f) - tiotropium bromide monohydrate 18 ug - spiriva handihaler (tiotropium bromide inhalation powder) is indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (copd), including chronic bronchitis and emphysema. spiriva handihaler is indicated to reduce exacerbations in copd patients. spiriva handihaler is contraindicated in patients with a hypersensitivity to ipratropium or tiotropium.  in clinical trials and postmarketing experience with spiriva handihaler, immediate hypersensitivity reactions, including angioedema (including swelling of the lips, tongue, or throat), itching, or rash have been reported. teratogenic effects, pregnancy category c. there are no adequate and well-controlled studies in pregnant women.  spiriva handihaler should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. no evidence of structural alterations was observed in rats and rabbits at inhalation tiotropium doses of up to approximately 660 and 6

Malta - engelsk - Medicines Authority

demo s.a. pharmaceutical industry 21st km national road athens - lamia 14568 krioneri, greece - tiotropium bromide - inhalation powder, hard capsule - tiotropium bromide 21.7 µg - drugs for obstructive airway diseases

Hellas - gresk - Εθνικός Οργανισμός Φαρμάκων

mylan ireland limited, ireland unit 35/36 grange parade, - dublin 13 - tiotropium bromide - inhpd.cap (ΚΟΝΙΣ ΓΙΑ ΕΙΣΠΝΟΗ (ΣΚΛΗΡΟ ΚΑΨΑΚΙΟ)) - 18mcg/cap - tiotropium bromide 0,022mg - tiotropium bromide

Hellas - gresk - Εθνικός Οργανισμός Φαρμάκων

win medica ΦΑΡΜΑΚΕΥΤΙΚΗ ΑΝΩΝΥΜΗ ΕΤΑΙΡΕΙΑ Δ.Τ. win medica a.e. Οιδίποδος 1-3 & Παράδρομος Αττικής Οδού 33-35, 152 38 Χαλάνδρι 210.7488821 - tiotropium bromide monohydrate - inh.pd.dos (ΚΟΝΙΣ ΓΙΑ ΕΙΣΠΝΟΗ, ΣΕ ΔΟΣΕΙΣ) - 10mcg/dose - tiotropium bromide monohydrate 16mcg - tiotropium bromide

Israel - engelsk - Ministry of Health

boehringer ingelheim israel ltd. - tiotropium bromide - inhalation powder hard capsules - tiotropium bromide 18 mcg - tiotropium bromide - tiotropium bromide - tiotropium is a bronchodilator for the maintenance treatment of chronic obstructive pulmonary disease (copd).

USA - engelsk - NLM (National Library of Medicine)

boehringer ingelheim pharmaceuticals, inc. - tiotropium bromide monohydrate (unii: l64sxo195n) (tiotropium - unii:0eb439235f) - tiotropium 18 ug - spiriva handihaler (tiotropium bromide inhalation powder) is indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (copd), including chronic bronchitis and emphysema. spiriva handihaler is indicated to reduce exacerbations in copd patients. spiriva handihaler is contraindicated in patients with a hypersensitivity to tiotropium, ipratropium, or any components of this product [see warnings and precautions (5.2)] . in clinical trials and postmarketing experience with spiriva handihaler, immediate hypersensitivity reactions, including angioedema (including swelling of the lips, tongue, or throat), itching, or rash have been reported [see warnings and precautions (5.2)]. risk summary the limited human data with spiriva handihaler use during pregnancy are insufficient to inform a drug-associated risk of adverse pregnancy-related outcomes. based on animal reproduction studies, no structural abnormalities were observed when tiotropium was