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

arrotex pharmaceuticals pty ltd - timolol maleate, quantity: 6.83 mg/ml (equivalent: timolol, qty 5 mg/ml); dorzolamide hydrochloride, quantity: 22.26 mg/ml (equivalent: dorzolamide, qty 20 mg/ml) - eye drops, solution - excipient ingredients: benzalkonium chloride; water for injections; sodium hydroxide; sodium citrate dihydrate; hyetellose; mannitol - the treatment of elevated intraocular pressure (iop) in patients with ocular hypertension or open-angle glaucoma when concomitant therapy is appropriate.

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

arrotex pharmaceuticals pty ltd - timolol maleate, quantity: 6.83 mg/ml (equivalent: timolol, qty 5 mg/ml); dorzolamide hydrochloride, quantity: 22.26 mg/ml (equivalent: dorzolamide, qty 20 mg/ml) - eye drops, solution - excipient ingredients: sodium hydroxide; benzalkonium chloride; hyetellose; water for injections; mannitol; sodium citrate dihydrate - the treatment of elevated intraocular pressure (iop) in patients with ocular hypertension or open-angle glaucoma when concomitant therapy is appropriate.

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

arrotex pharmaceuticals pty ltd - timolol maleate, quantity: 6.83 mg/ml (equivalent: timolol, qty 5 mg/ml); dorzolamide hydrochloride, quantity: 22.26 mg/ml (equivalent: dorzolamide, qty 20 mg/ml) - eye drops, solution - excipient ingredients: sodium citrate dihydrate; benzalkonium chloride; mannitol; hyetellose; sodium hydroxide; water for injections - the treatment of elevated intraocular pressure (iop) in patients with ocular hypertension or open-angle glaucoma when concomitant therapy is appropriate.

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

arrotex pharmaceuticals pty ltd - timolol maleate, quantity: 6.83 mg/ml (equivalent: timolol, qty 5 mg/ml); dorzolamide hydrochloride, quantity: 22.26 mg/ml (equivalent: dorzolamide, qty 20 mg/ml) - eye drops, solution - excipient ingredients: hyetellose; sodium citrate dihydrate; mannitol; sodium hydroxide; benzalkonium chloride; water for injections - the treatment of elevated intraocular pressure (iop) in patients with ocular hypertension or open-angle glaucoma when concomitant therapy is appropriate.

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

bausch & lomb incorporated - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1) - dorzolamide 20 mg in 1 ml - dorzolamide hydrochloride ophthalmic solution 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)] . risk summary 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 r

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

sandoz inc - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1) - dorzolamide 20 mg in 1 ml - 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

Israel - English - Ministry of Health

abic marketing ltd, israel - dorzolamide as hcl; timolol as maleate - ophthalmic solution - dorzolamide as hcl 20 mg/ml; timolol as maleate 5 mg/ml - timolol - for the treatment of elevated intraocular pressure (iop) in patients with ocular hypertension, open-angle glaucoma or other secondary open-angle glaucomas when concomitant therapy is appropriate, and in patients who may be sensitive to a preservative, or for whom the use of a preservative-free formulation is otherwise advisable.

Canada - English - Health Canada

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

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

actavis pharma, inc. - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1) - dorzolamide 20 mg in 1 ml