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

somerset therapeutics, llc - latanoprost (unii: 6z5b6hvf6o) (latanoprost - unii:6z5b6hvf6o) - latanoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension. known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this product. risk summary there are no adequate and well-controlled studies of latanoprost ophthalmic solution administration in pregnant women.to inform drug-associated risks. in animal reproduction studies, intravenous (iv) administration of latanoprost to pregnant rabbits and rats throughout the period of organogenesis produced malformations, embryofetal lethality and spontaneous abortion at clinically relevant doses [see data] . the background risk of major birth defects and miscarriage for the indicated population is unknown. however, the background risk in the u.s. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20% of clinically recognized pregnancies. data animal data embryofetal studies were conducted in pregnant rabb

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

nucare pharmaceuticals,inc. - latanoprost (unii: 6z5b6hvf6o) (latanoprost - unii:6z5b6hvf6o) - latanoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension. known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this product. risk summary there are no adequate and well-controlled studies of latanoprost ophthalmic solution administration in pregnant women.to inform drug-associated risks. in animal reproduction studies, intravenous (iv) administration of latanoprost to pregnant rabbits and rats throughout the period of organogenesis produced malformations, embryofetal lethality and spontaneous abortion at clinically relevant doses [see data] . the background risk of major birth defects and miscarriage for the indicated population is unknown. however, the background risk in the u.s. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20% of clinically recognized pregnancies. data animal data embryofetal studies were conducted i

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

medis pharma pty ltd - latanoprost -

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

mylan pharmaceuticals inc. - latanoprost (unii: 6z5b6hvf6o) (latanoprost - unii:6z5b6hvf6o) - latanoprost 50 ug in 1 ml

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

proficient rx lp - latanoprost (unii: 6z5b6hvf6o) (latanoprost - unii:6z5b6hvf6o) - latanoprost sterile ophthalmic solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this product. teratogenic effects: pregnancy category c. reproduction studies have been performed in rats and rabbits. in rabbits, an incidence of 4 of 16 dams had no viable fetuses at a dose that was approximately 80 times the maximum human dose, and the highest nonembryocidal dose in rabbits was approximately 15 times the maximum human dose. there are no adequate and well-controlled studies in pregnant women. latanoprost should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. it is not known whether this drug or its metabolites are excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when latanoprost is administered to a nursing woman. safety and effectiveness

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

nucare pharmaceuticals,inc. - latanoprost (unii: 6z5b6hvf6o) (latanoprost - unii:6z5b6hvf6o) - latanoprost sterile ophthalmic solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this product. teratogenic effects: pregnancy category c. reproduction studies have been performed in rats and rabbits. in rabbits, an incidence of 4 of 16 dams had no viable fetuses at a dose that was approximately 80 times the maximum human dose, and the highest nonembryocidal dose in rabbits was approximately 15 times the maximum human dose. there are no adequate and well-controlled studies in pregnant women. latanoprost should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. it is not known whether this drug or its metabolites are excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when latanoprost is administered to a nursing woman. safety and effectiveness

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

nucare pharmaceuticals,inc. - latanoprost (unii: 6z5b6hvf6o) (latanoprost - unii:6z5b6hvf6o) - latanoprost sterile ophthalmic solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this product. teratogenic effects: pregnancy category c. reproduction studies have been performed in rats and rabbits. in rabbits, an incidence of 4 of 16 dams had no viable fetuses at a dose that was approximately 80 times the maximum human dose, and the highest nonembryocidal dose in rabbits was approximately 15 times the maximum human dose. there are no adequate and well-controlled studies in pregnant women. latanoprost should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. it is not known whether this drug or its metabolites are excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when latanoprost is administered to a nursing woman. safety and effectiveness

Ireland - English - HPRA (Health Products Regulatory Authority)

generics (uk) limited - latanoprost - eye drops solution - 50 microgram/ml - latanoprost

Malta - English - Medicines Authority

actavis group ptc ehf revkjavikurvegi 76-78, 220 hafnarfjordur, iceland - latanoprost - eye drops, solution - latanoprost 50 µg/ml - ophthalmologicals

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

apotex pty ltd - latanoprost -