USA - engelsk - NLM (National Library of Medicine)

akorn - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1), timolol maleate (unii: p8y54f701r) (timolol anhydrous - unii:5jky92s7br) - dorzolamide hydrochloride-timolol maleate ophthalmic solution (preservative-free) is indicated for the reduction of elevated intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target iop determined after multiple measurements over time). the iop-lowering of dorzolamide hydrochloride-timolol maleate ophthalmic solution administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day [see clinical studies (14.1)] . dorzolamide hydrochloride-timolol maleate ophthalmic solution (preservative-free) is contraindicated in patients with bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease [see warnings and precautions (5.1)] . dorzolamide hydrochloride-timolol maleate ophthalmic solution (preservative-free) is contraindicated in patients with sinus bra

USA - engelsk - NLM (National Library of Medicine)

alvogen inc. - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1) - dorzolamide 22.3 mg in 1 ml

Filippinene - engelsk - FDA (Food And Drug Administration)

croma medic, inc. - dorzolamide (as hydrochloride) , timolol (as maleate) - sterile solution, ophthalmic (drops) - 20mg + 5mg / ml

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

sandoz sa-nv - chlorhydrate de dorzolamide 22,26 mg/ml - eq. dorzolamide 20 mg/ml; maléate de timolol 6,83 mg/ml - eq. timolol 5 mg/ml - collyre en solution - 20 mg/ml - 5 mg/ml - chlorhydrate de dorzolamide 22.26 mg/ml; maléate de timolol 6.83 mg/ml - timolol, combinations

USA - engelsk - NLM (National Library of Medicine)

alvogen inc. - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1) - dorzolamide 22.3 mg in 1 ml

USA - engelsk - NLM (National Library of Medicine)

aurobindo pharma limited - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1), timolol maleate (unii: p8y54f701r) (timolol anhydrous - unii:5jky92s7br) - dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free is indicated for the reduction of elevated intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target iop determined after multiple measurements over time). the iop-lowering of dorzolamide hydrochloride and timolol maleate ophthalmic solution administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day [see clinical studies (14.1)]. dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free is contraindicated in patients with bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease [see warnings and precautions (5.1)]. dorzolamide hydrochloride and timolol maleate ophthalmic solution preservative free is contraindicated in patients with s

USA - engelsk - NLM (National Library of Medicine)

leading pharma, llc - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1) - 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) ]. teratogenic effects. developmental toxicity studies with dorzolamide hydrochloride in rabbits at oral doses of ≥ 2.5 mg/kg/day revealed malformations of the vertebral bodies. these malformations occurred at doses that caused metabolic acidosis with decreased body weight gain in dams and decreased fetal weights. no treatment-related malformations were seen at 1 mg/kg/day. these doses represent estimated plasma cmax levels in rabbits, 37 and 15 times higher than the lower limit of detection in human plasma following ocular administration, respectively. there are no adequate and well-controlled studies in pregnant women. dorzolamide hydrochloride ophthalmic solution should b

USA - engelsk - NLM (National Library of Medicine)

alembic pharmaceuticals inc. - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1) - 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) ]. teratogenic effects . pregnancy category c. developmental toxicity studies with dorzolamide hydrochloride in rabbits at oral doses of ≥ 2.5 mg/kg/day revealed malformations of the vertebral bodies. these malformations occurred at doses that caused metabolic acidosis with decreased body weight gain in dams and decreased fetal weights. no treatment-related malformations were seen at 1 mg/kg/day. these doses represent estimated plasma cmax levels in rabbits, 37 and 15 times higher than the lower limit of detection in human plasma following ocular administration, respectively. there are no adequate and well-controlled studies in pregnant women. dorzolamide hydrochloride o

USA - engelsk - NLM (National Library of Medicine)

ingenus pharmaceuticals, llc - dorzolamide hydrochloride (unii: qzo5366ew7) (dorzolamide - unii:9jdx055tw1), timolol maleate (unii: p8y54f701r) (timolol anhydrous - unii:5jky92s7br) - dorzolamide hydrochloride and timolol maleate ophthalmic solution (preservative free) is indicated for the reduction of elevated intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target iop determined after multiple measurements over time). the iop-lowering of dorzolamide hydrochloride and timolol maleate ophthalmic solution administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day [see clinical studies (14.1)]. dorzolamide hydrochloride and timolol maleate ophthalmic solution (preservative free) is contraindicated in patients with bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease [see warnings and precautions (5.1)]. dorzolamide hydrochloride and timolol maleate ophthalmic solution (preservative free) is contraindicated in patients

Israel - hebraisk - Ministry of Health

rafa laboratories ltd - dorzolamide as hydrochloride; timolol as maleate - תמיסה לעין - dorzolamide as hydrochloride 20 mg/ml; timolol as maleate 5 mg/ml - timolol - carbonic anhydrase inhibitors - for the treatment of elevated intraocular pressure (iop ) in patients with ocular hypertension, open-angle glaucoma, or other secondary open-angle glaucoma when concomitant therapy is appropriate.