Ireland - English - HPRA (Health Products Regulatory Authority)

merit pharmaceuticals limited - tiotropium bromide - inhalation powder, hard capsule - 18 microgram(s) - anticholinergics; tiotropium bromide

New Zealand - English - Medsafe (Medicines Safety Authority)

boehringer ingelheim (nz) limited - tiotropium bromide monohydrate 3.125ug equivalent to tiotropium 2.5 µg/dose - solution for inhalation - 2.5 mcg/dose - active: tiotropium bromide monohydrate 3.125ug equivalent to tiotropium 2.5 µg/dose excipient: benzalkonium chloride disodium edetate hydrochloric acid purified water - spiriva respimat is indicated for the long term once daily maintenance treatment of bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease (copd), including chronic bronchitis and emphysema. spiriva reduces the frequency of exacerbations and improves exercise tolerance and health-related quality of life.

Ireland - English - HPRA (Health Products Regulatory Authority)

imbat limited - tiotropium bromide - inhalation powder, hard capsule - 18 microgram(s) - anticholinergics; tiotropium bromide

Malta - English - Medicines Authority

teva b.v. swensweg 5, 2031 ga haarlem, netherlands - tiotropium bromide - inhalation powder, hard capsule - tiotropium bromide 0.016 mg - drugs for obstructive airway diseases

Canada - English - Health Canada

boehringer ingelheim (canada) ltd ltee - tiotropium (tiotropium bromide monohydrate) - capsule - 18mcg - tiotropium (tiotropium bromide monohydrate) 18mcg - antimuscarinics antispasmodics

Australia - English - Department of Health (Therapeutic Goods Administration)

boehringer ingelheim pty ltd - olodaterol hydrochloride, quantity: 2.736 microgram/actuation (equivalent: olodaterol, qty 2.5 microgram/actuation); tiotropium bromide monohydrate, quantity: 3.124 microgram/actuation (equivalent: tiotropium, qty 2.5 microgram/actuation) - inhalation, conventional - excipient ingredients: purified water; benzalkonium chloride; hydrochloric acid; disodium edetate - spiolto respimat is indicated as a once-daily maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (copd).

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

a-s medication solutions - tiotropium bromide monohydrate (unii: l64sxo195n) (tiotropium - unii:0eb439235f) - 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

Canada - English - Health Canada

boehringer ingelheim (canada) ltd ltee - tiotropium (tiotropium bromide monohydrate) - solution - 2.5mcg - tiotropium (tiotropium bromide monohydrate) 2.5mcg - antimuscarinics antispasmodics

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

a-s medication solutions - tiotropium bromide monohydrate (unii: l64sxo195n) (tiotropium - unii:0eb439235f) - 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

Ireland - English - HPRA (Health Products Regulatory Authority)

teva b.v. - tiotropium bromide - inhalation powder, hard capsule - 10 microgram(s) - anticholinergics; tiotropium bromide