Australien - Englisch - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - dorzolamide hydrochloride,timolol maleate -

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

micro labs pty ltd - timolol maleate, quantity: 3.4 mg/ml (equivalent: timolol, qty 2.5 mg/ml) - eye drops, solution - excipient ingredients: water for injections; sodium hydroxide; monobasic sodium phosphate dihydrate; dibasic sodium phosphate dodecahydrate; benzalkonium chloride - timolol ophthalmic solution is indicated for the reduction of elevated intraocular pressure. in clinical trials it has been shown to reduce intraocular pressure in: patients with ocular hypertension patients with chronic open-angle glaucoma aphakic patients with glaucoma

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

micro labs pty ltd - timolol maleate, quantity: 6.8 mg/ml (equivalent: timolol, qty 5 mg/ml) - eye drops, solution - excipient ingredients: monobasic sodium phosphate dihydrate; sodium hydroxide; dibasic sodium phosphate dodecahydrate; benzalkonium chloride; water for injections - timolol ophthalmic solution is indicated for the reduction of elevated intraocular pressure.,in clinical trials it has been shown to reduce intraocular pressure in:,patients with ocular hypertension,patients with chronic open-angle glaucoma,aphakic patients with glaucoma

Kanada - Englisch - Health Canada

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

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

apotex corp. - brimonidine tartrate (unii: 4s9cl2dy2h) (brimonidine - unii:e6gnx3hhte), timolol maleate (unii: p8y54f701r) (timolol anhydrous - unii:5jky92s7br) - brimonidine tartrate/timolol maleate ophthalmic solution 0.2%/0.5% is an alpha-adrenergic receptor agonist with a beta-adrenergic receptor inhibitor indicated for the reduction of elevated intraocular pressure (iop) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled iop; the iop-lowering of brimonidine tartrate/timolol maleate ophthalmic solution dosed twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol maleate ophthalmic solution dosed twice a day and 0.2% brimonidine tartrate ophthalmic solution dosed three times per day. brimonidine tartrate/timolol maleate ophthalmic solution is contraindicated in patients with reactive airway disease including bronchial asthma; a history of bronchial asthma; severe chronic obstructive pulmonary disease [see warnings and precautions (5.1, 5.3)] . brimonidine tartrate/timolol maleate ophthalmic solution is contraindicated in patients with sinus bradycardia; second or third degree atrioventricular block; overt cardiac failure [see warnings and precautions (5.2)] ; cardiogenic shock. brimonidine tartrate/timolol maleate ophthalmic solution is contraindicated in neonates and infants (under the age of 2 years). local hypersensitivity reactions have occurred following the use of different components of brimonidine tartrate/timolol maleate ophthalmic solution. brimonidine tartrate/timolol maleate ophthalmic solution is contraindicated in patients who have exhibited a hypersensitivity reaction to any component of this medication in the past. teratogenicity studies have been performed in animals. brimonidine tartrate was not teratogenic when given orally during gestation days 6 through 15 in rats and days 6 through 18 in rabbits. the highest doses of brimonidine tartrate in rats (2.5 mg/kg/day) and rabbits (5 mg/kg/day) achieved auc exposure values 580 and 37-fold higher, respectively, than similar values estimated in humans treated with brimonidine tartrate/timolol maleate ophthalmic solution, 1 drop in both eyes twice daily. teratogenicity studies with timolol in mice, rats, and rabbits at oral doses up to 50 mg/kg/day [4,200 times the maximum recommended human ocular dose of 0.012 mg/kg/day on a mg/kg basis (mrhod)] demonstrated no evidence of fetal malformations. although delayed fetal ossification was observed at this dose in rats, there were no adverse effects on postnatal development of offspring. doses of 1,000 mg/kg/day (83,000 times the mrhod) were maternotoxic in mice and resulted in an increased number of fetal resorptions. increased fetal resorptions were also seen in rabbits at doses 8,300 times the mrhod without apparent maternotoxicity. there are no adequate and well-controlled studies in pregnant women; however, in animal studies, brimonidine crossed the placenta and entered into the fetal circulation to a limited extent. because animal reproduction studies are not always predictive of human response, brimonidine tartrate/timolol maleate ophthalmic solution should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. timolol has been detected in human milk following oral and ophthalmic drug administration. it is not known whether brimonidine tartrate is excreted in human milk, although in animal studies, brimonidine tartrate has been shown to be excreted in breast milk. because of the potential for serious adverse reactions from brimonidine tartrate/timolol maleate ophthalmic solution in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. brimonidine tartrate/timolol maleate ophthalmic solution is contraindicated in children under the age of 2 years [see contraindications (4.3)] . during post-marketing surveillance, apnea, bradycardia, coma, hypotension, hypothermia, hypotonia, lethargy, pallor, respiratory depression, and somnolence have been reported in infants receiving brimonidine. the safety and effectiveness of brimonidine tartrate and timolol maleate have not been studied in children below the age of 2 years. the safety and effectiveness of brimonidine tartrate/timolol maleate ophthalmic solution have been established in the age groups 2 – 16 years of age. use of brimonidine tartrate/timolol maleate ophthalmic solution in these age groups is supported by evidence from adequate and well-controlled studies of brimonidine tartrate/timolol maleate ophthalmic solution in adults with additional data from a study of the concomitant use of brimonidine tartrate ophthalmic solution 0.2% and timolol maleate ophthalmic solution in pediatric glaucoma patients (ages 2 to 7 years). in this study, brimonidine tartrate ophthalmic solution 0.2% was dosed three times a day as adjunctive therapy to beta-blockers. the most commonly observed adverse reactions were somnolence (50%-83% in patients 2 to 6 years) and decreased alertness. in pediatric patients 7 years of age or older (>20 kg), somnolence appears to occur less frequently (25%). approximately 16% of patients on brimonidine tartrate ophthalmic solution discontinued from the study due to somnolence. no overall differences in safety or effectiveness have been observed between elderly and other adult patients.

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - latanoprost, quantity: 50 microgram/ml; timolol maleate, quantity: 5 mg/ml - eye drops, solution - excipient ingredients: benzalkonium chloride; monobasic sodium phosphate monohydrate; water for injections; sodium hydroxide; dibasic sodium phosphate; hydrochloric acid; sodium chloride - reduction of elevated intraocular pressure in patients with open-angle glaucoma and ocular hypertension who are insufficiently responsive to beta-blockers, prostaglandins or other intraocular pressure lowering medications. latanoprost/timolol eye drops should not be used to initiate therapy.

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

viatris pty ltd - timolol maleate, quantity: 6.83 mg/ml (equivalent: timolol, qty 5 mg/ml); latanoprost, quantity: 50 microgram/ml - eye drops, solution - excipient ingredients: dibasic sodium phosphate; water for injections; monobasic sodium phosphate monohydrate; benzalkonium chloride; sodium chloride; hydrochloric acid; sodium hydroxide - reduction of elevated intraocular pressure in patients with open-angle glaucoma and ocular hypertension who are insufficiently responsive to beta-blockers, prostaglandins or other intraocular pressure lowering medications. xalamol 50/5 should not be used to initiate therapy.

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

aspen pharmacare australia pty ltd - timolol maleate, quantity: 6.83 mg/ml (equivalent: timolol, qty 5 mg/ml); latanoprost, quantity: 0.05 mg/ml - eye drops, solution - excipient ingredients: sodium hydroxide; benzalkonium chloride; dibasic sodium phosphate; water for injections; sodium chloride; hydrochloric acid; monobasic sodium phosphate monohydrate - the reduction of elevated intraocular pressure in patients with open-angle glaucoma and ocular hypertension who are insufficiently responsive to beta-blockers, prostaglandins or other intraocular pressure lowering medications. latanocom should not be used to initiate therapy.

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - timolol maleate, quantity: 6.83 mg/ml (equivalent: timolol, qty 5 mg/ml); latanoprost, quantity: 0.05 mg/ml - eye drops, solution - excipient ingredients: purified water; benzalkonium chloride; dibasic sodium phosphate dodecahydrate; sodium hydroxide; monobasic sodium phosphate dihydrate; hydrochloric acid; sodium chloride - reduction of elevated intraocular pressure in patients with open-angle glaucoma and ocular hypertension who are insufficiently responsive to beta-blockers, prostaglandins or other intraocular pressure lowering medications. latanoprost/timolol (50 microgram/ml/5 mg/ml) eye drops should not be used to initiate therapy.

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

abbvie pty ltd - timolol maleate, quantity: 6.8 mg/ml (equivalent: timolol, qty 5 mg/ml); bimatoprost, quantity: 300 microgram/ml - eye drops, solution - excipient ingredients: dibasic sodium phosphate heptahydrate; hydrochloric acid; citric acid monohydrate; purified water; sodium chloride; sodium hydroxide - ganfort pf 0.3/5 eye drops are indicated for the reduction of intraocular pressure (iop) in patients with chronic open-angle glaucoma or ocular hypertension who are insufficiently responsive to monotherapy.