Ameerika Ühendriigid - inglise - 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

Ameerika Ühendriigid - inglise - 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

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - tiotropium bromide monohydrate, quantity: 3.1235 microgram/actuation (equivalent: tiotropium, qty 2.5 microgram/actuation) - inhalation, conventional - excipient ingredients: purified water; hydrochloric acid; disodium edetate; benzalkonium chloride - copd: spiriva respimat is indicated for the long term maintenance treatment of bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease (copd). spiriva respimat is indicated for the prevention of copd exacerbations.,asthma: spiriva respimat is indicated as add-on maintenance bronchodilator treatment in patients aged 6 years and older with moderate to severe asthma.

Iirimaa - inglise - HPRA (Health Products Regulatory Authority)

imed healthcare ltd. - tiotropium bromide monohydrate; olodaterol hydrochloride - inhalation vapour, solution - 2.5/2.5 µg/µg

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - tiotropium bromide, quantity: 15.6 microgram (equivalent: tiotropium, qty 13 microgram) - capsule, hard - excipient ingredients: lactose monohydrate - tiotropium-teva is indicated for the long term maintenance treatment of bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease (copd).,tiotropium-teva is indicated for the prevention of copd exacerbations

Iisrael - inglise - Ministry of Health

boehringer ingelheim israel ltd. - tiotropium bromide as monohydrate - solution for inhalation - tiotropium bromide as monohydrate 2.5 mcg - tiotropium bromide - maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (copd).copd:tiotropium is indicated as a maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (copd).asthma:spiriva respimat is indicated as add-on maintenance bronchodilator treatment in patients aged 6 years and older with severe asthma who experienced one or more severe asthma exacerbations in the preceding year.

Singapur - inglise - HSA (Health Sciences Authority)

boehringer ingelheim singapore pte. ltd. - olodaterol hydrochloride 0.002736 mg/actuation eqv olodaterol; tiotropium bromide monohydrate 0.003124 mg/actuation eqv tiotropium - solution - olodaterol hydrochloride 0.002736 mg/actuation eqv olodaterol 0.0025 mg/actuation; tiotropium bromide monohydrate 0.003124 mg/actuation eqv tiotropium 0.0025 mg/actuation

Singapur - inglise - HSA (Health Sciences Authority)

boehringer ingelheim singapore pte. ltd. - olodaterol hydrochloride eqv olodaterol; tiotropium bromide monohydrate eqv tiotropium - solution - olodaterol hydrochloride eqv olodaterol 0.0025 mg/actuation; tiotropium bromide monohydrate eqv tiotropium 0.0025 mg/actuation

Suurbritannia - inglise - MHRA (Medicines & Healthcare Products Regulatory Agency)

am distributions (yorkshire) ltd - tiotropium bromide - inhalation solution - 2.5microgram/1dose

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - tiotropium, quantity: 18 microgram (equivalent: tiotropium bromide monohydrate, qty 22.5 microgram) - inhalation, powder for - excipient ingredients: lactose monohydrate - spiriva is indicated for the long term maintenance treatment of bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease (copd). spiriva is indicated for the prevention of copd exacerbations.