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

arrotex pharmaceuticals pty ltd - timolol maleate, quantity: 6.8 mg/ml (equivalent: timolol, qty 5 mg); dorzolamide hydrochloride, quantity: 22.3 mg/ml (equivalent: dorzolamide, qty 20 mg) - eye drops, solution - excipient ingredients: mannitol; sodium citrate dihydrate; water for injections; benzalkonium chloride; sodium hydroxide; hyetellose - dorzolamide/timolol 20/5 eye drops are indicated in the treatment of elevated intraocular pressure (iop) in patients with ocular hypertension or open-angle glaucoma when concomitant therapy is appropriate.

Canada - English - Health Canada

hikma canada limited - dorzolamide (dorzolamide hydrochloride); timolol (timolol maleate) - solution - 20mg; 5mg - dorzolamide (dorzolamide hydrochloride) 20mg; timolol (timolol maleate) 5mg - beta-adrenergic agents

Ireland - English - HPRA (Health Products Regulatory Authority)

actavis group ptc ehf - dorzolamide hydrochloride - eye drops solution - 20 mg/ml - dorzolamide

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

a-s medication solutions - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1) - dorzolamide hydrochloride ophthalmic solution, 2% is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. dorzolamide hydrochloride ophthalmic solution is contraindicated in patients who are hypersensitive to any component of this product [see warnings and precautions (5.1)]. there are no adequate and well-controlled studies in pregnant women with dorzolamide hydrochloride ophthalmic solution. dorzolamide caused fetal vertebral malformations when administered orally to rabbits at 2.5 mg/kg/day (37 times the clinical exposure). dorzolamide administered during the period of organogenesis was not teratogenic in rabbits dosed up to 1 mg/kg/day (15 times the clinical exposure). dorzolamide hydrochloride administered orally to rats during late gestation and lactation caused growth delays in offspring at 7.5 mg/kg/day (52 times the clinical exposure). growth was not delayed at 1 mg/kg/day (8.0 times the clinical exposure). the background risk of maj

Canada - English - Health Canada

alcon canada inc - dorzolamide (dorzolamide hydrochloride); timolol (timolol maleate) - solution - 2.0%; 0.5% - dorzolamide (dorzolamide hydrochloride) 2.0%; timolol (timolol maleate) 0.5% - beta-adrenergic agents

Ireland - English - HPRA (Health Products Regulatory Authority)

pharmaswiss ceska republika s.r.o. - dorzolamide - eye drops, solution - 20 milligram(s)/millilitre - carbonic anhydrase inhibitors; dorzolamide

Canada - English - Health Canada

laboratoire riva inc. - dorzolamide (dorzolamide hydrochloride) - solution - 2% - dorzolamide (dorzolamide hydrochloride) 2% - carbonic anhydrase inhibitors

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - dorzolamide hydrochloride - eye drops, solution - 20 milligram(s)/millilitre - carbonic anhydrase inhibitors; dorzolamide

Ireland - English - HPRA (Health Products Regulatory Authority)

bausch + lomb ireland limited - dorzolamide - eye drops, solution - 20 milligram(s)/millilitre - carbonic anhydrase inhibitors; dorzolamide

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

merck sharp & dohme llc - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1) - dorzolamide 20 mg in 1 ml - trusopt® is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. trusopt is contraindicated in patients who are hypersensitive to any component of this product [see warnings and precautions (5.1)] . risk summary there are no adequate and well-controlled studies in pregnant women with trusopt. dorzolamide caused fetal vertebral malformations when administered orally to rabbits at 2.5 mg/kg/day (37 times the clinical exposure). dorzolamide administered during the period of organogenesis was not teratogenic in rabbits dosed up to 1 mg/kg/day (15 times the clinical exposure). dorzolamide hydrochloride administered orally to rats during late gestation and lactation caused growth delays in offspring at 7.5 mg/kg/day (52 times the clinical exposure). growth was not delayed at 1 mg/kg/day (8.0 times the clinical exposure). the background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general populati