아일랜드 - 영어 - HPRA (Health Products Regulatory Authority)

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

아일랜드 - 영어 - HPRA (Health Products Regulatory Authority)

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

미국 - 영어 - NLM (National Library of Medicine)

gland pharma limited - 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)]. 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 risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data developmental toxicity studies were conducted in pregnant rabbits administered dorzolamide hydrochloride orally during the period of organogenesis from gestation days 6 through 18 at doses of 0.2, 1, 2.5, 5, and 10 mg/kg/day. the developmental lowest observed adverse effect level (loael) was 2.5 mg/kg/day, based on vertebral malformations and decreased fetal body weight. the maternal loael was 2.5 mg/kg/day, based on metabolic acidosis and reduced weight gain. the maternal and developmental no adverse effect levels (noaels) were 1 mg/kg/day. the rabbit doses of 1 and 2.5 mg/kg/day represent estimated plasma cmax levels in rabbits 15 and 37 times higher than the lower limit of detection in human plasma following ocular administration, respectively. dorzolamide hydrochloride was administered orally to rats during late gestation and lactation (gestation day 17 through postpartum day 20) at doses of 0.1, 1, or 7.5 mg/kg/day. the developmental loael was 7.5 mg/kg/day, based on reduced birth weight, reduced weight gain, and a slight delay in postnatal development (incisor eruption, vaginal canalization and eye openings) secondary to lower offspring body weight. this 7.5 mg/kg/day dose represents an estimated plasma cmax level in rats 52 times higher than the lower limit of detection in human plasma following ocular administration. the developmental noael was 1 mg/kg/day. the maternal loael was 1 mg/kg/day, based on reduced body weight gain. the maternal noael was 0.1 mg/kg/day. the rat doses of 1 and 0.1 mg/kg/day represent estimated plasma cmax levels in rats approximately 8.0 times and approximately equal (1x), respectively to the lower limit of detection in human plasma following ocular administration. risk summary there are no data on the presence of dorzolamide hydrochloride ophthalmic solution in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for dorzolamide hydrochloride ophthalmic solution and any potential adverse effects on the breast-fed child from dorzolamide hydrochloride ophthalmic solution. dorzolamide is present in the milk of lactating rats (see data) . data   animal data lactating rats were dosed orally with 7.5 mg/kg/day of dorzolamide hydrochloride; dorzolamide and the n-desethyl metabolite were detected in the milk. safety and effectiveness of dorzolamide hydrochloride ophthalmic solution have been demonstrated in pediatric patients in a 3-month, multicenter, double-masked, active-treatment-controlled trial. no overall differences in safety or effectiveness have been observed between elderly and younger patients. dorzolamide has not been studied in patients with severe renal impairment (crcl < 30 ml/min). because dorzolamide and its metabolite are excreted predominantly by the kidney, dorzolamide hydrochloride ophthalmic solution is not recommended in such patients.  dorzolamide has not been studied in patients with hepatic impairment and should therefore be used with caution in such patients.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

apotex pty ltd - dorzolamide hydrochloride -

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

mundipharma 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: mannitol; sodium hydroxide; water for injections; hyetellose; sodium citrate dihydrate - cosopt preservative free is indicated in the treatment of elevated intraocular pressure (iop) in patients with ocular hypertension or open-angle glaucoma when concominant therapy is appropriate.

아일랜드 - 영어 - HPRA (Health Products Regulatory Authority)

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

영국 - 영어 - MHRA (Medicines & Healthcare Products Regulatory Agency)

accord-uk ltd - dorzolamide hydrochloride; timolol maleate - eye drops - 20mg/1ml ; 5mg/1ml

캐나다 - 영어 - Health Canada

micro labs limited - timolol (timolol maleate); dorzolamide (dorzolamide hydrochloride) - solution - 5mg; 20mg - timolol (timolol maleate) 5mg; dorzolamide (dorzolamide hydrochloride) 20mg

아일랜드 - 영어 - HPRA (Health Products Regulatory Authority)

pharmaswiss ceska republika s.r.o. - dorzolamide hydrochloride; timolol maleate - eye drops, solution - 20mg/ml+5 milligram(s)/millilitre - beta blocking agents1); timolol, combinations

아일랜드 - 영어 - HPRA (Health Products Regulatory Authority)

bausch + lomb ireland limited - dorzolamide hydrochloride; timolol maleate - eye drops, solution - 20mg/ml+5 milligram(s)/millilitre - beta blocking agents1); timolol, combinations