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

micro labs limited - tafluprost (unii: 1o6wq6t7g3) (tafluprost - unii:1o6wq6t7g3) - tafluprost ophthalmic solution, 0.0015% is indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. none. pregnancy category c. teratogenic effects: in embryo-fetal development studies in rats and rabbits, tafluprost administered intravenously was teratogenic. tafluprost caused increases in post-implantation losses in rats and rabbits and reductions in fetal body weights in rats. tafluprost also increased the incidence of vertebral skeletal abnormalities in rats and the incidence of skull, brain and spine malformations in rabbits. in rats, there were no adverse effects on embryo-fetal development at a dose of 3 mcg/kg/day corresponding to maternal plasma levels of tafluprost acid that were 343 times the maximum clinical exposure based on c max . in rabbits, effects were seen at a tafluprost dose of 0.03 mcg/kg/day corresponding to maternal plasma levels of tafluprost acid during organogenesis that were approximately 5 times higher than the

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

prasco laboratories - tafluprost (unii: 1o6wq6t7g3) (tafluprost - unii:1o6wq6t7g3) - tafluprost ophthalmic solution 0.0015% is indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. none. pregnancy category c. teratogenic effects: in embryo-fetal development studies in rats and rabbits, tafluprost administered intravenously was teratogenic. tafluprost caused increases in post-implantation losses in rats and rabbits and reductions in fetal body weights in rats. tafluprost also increased the incidence of vertebral skeletal abnormalities in rats and the incidence of skull, brain and spine malformations in rabbits. in rats, there were no adverse effects on embryo-fetal development at a dose of 3 mcg/kg/day corresponding to maternal plasma levels of tafluprost acid that were 343 times the maximum clinical exposure based on cmax . in rabbits, effects were seen at a tafluprost dose of 0.03 mcg/kg/day corresponding to maternal plasma levels of tafluprost acid during organogenesis that were approximately 5 times higher than the clinical exposu

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

sandoz inc - tafluprost (unii: 1o6wq6t7g3) (tafluprost - unii:1o6wq6t7g3) - tafluprost ophthalmic solution 0.0015% is indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. none. teratogenic effects in embryo-fetal development studies in rats and rabbits, tafluprost administered intravenously was teratogenic. tafluprost caused increases in post-implantation losses in rats and rabbits and reductions in fetal body weights in rats. tafluprost also increased the incidence of vertebral skeletal abnormalities in rats and the incidence of skull, brain and spine malformations in rabbits. in rats, there were no adverse effects on embryo-fetal development at a dose of 3 mcg/kg/day corresponding to maternal plasma levels of tafluprost acid that were 343 times the maximum clinical exposure based on cmax . in rabbits, effects were seen at a tafluprost dose of 0.03 mcg/kg/day corresponding to maternal plasma levels of tafluprost acid during organogenesis that were approximately 5 times higher than the clinical exposure based on cmax . at t

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

akorn - tafluprost (unii: 1o6wq6t7g3) (tafluprost - unii:1o6wq6t7g3) - tafluprost 0.0045 mg in 0.3 ml - zioptan® (tafluprost ophthalmic solution) 0.0015% is indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. none. pregnancy category c. teratogenic effects: in embryo-fetal development studies in rats and rabbits, tafluprost administered intravenously was teratogenic. tafluprost caused increases in post-implantation losses in rats and rabbits and reductions in fetal body weights in rats. tafluprost also increased the incidence of vertebral skeletal abnormalities in rats and the incidence of skull, brain and spine malformations in rabbits. in rats, there were no adverse effects on embryo-fetal development at a dose of 3 mcg/kg/day corresponding to maternal plasma levels of tafluprost acid that were 343 times the maximum clinical exposure based on cmax . in rabbits, effects were seen at a tafluprost dose of 0.03 mcg/kg/day corresponding to maternal plasma levels of tafluprost acid during organogenesis that were approximately 5 times higher than the cli

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

mundipharma pty ltd - tafluprost, quantity: 0.015 mg/ml - eye drops - excipient ingredients: polysorbate 80; glycerol; sodium hydroxide; monobasic sodium phosphate dihydrate; water for injections; disodium edetate; hydrochloric acid - saflutan is indicated for the reduction of elevated intraocular pressure in open-angle glaucoma or ocular hypertension, as monotherapy or as adjunctive therapy to beta blockers.

Malta - English - Medicines Authority

santen oy niittyhaankatu 20, 33720 tampere, finland - tafluprost, timolol maleate - eye drops, solution - tafluprost 15 µg/ml timolol maleate 5 mg/ml - ophthalmologicals

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

thea pharma inc. - tafluprost (unii: 1o6wq6t7g3) (tafluprost - unii:1o6wq6t7g3) - zioptan ® (tafluprost ophthalmic solution) 0.0015% is indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. none. pregnancy category c. teratogenic effects: in embryo-fetal development studies in rats and rabbits, tafluprost administered intravenously was teratogenic. tafluprost caused increases in post-implantation losses in rats and rabbits and reductions in fetal body weights in rats. tafluprost also increased the incidence of vertebral skeletal abnormalities in rats and the incidence of skull, brain and spine malformations in rabbits. in rats, there were no adverse effects on embryo-fetal development at a dose of 3 mcg/kg/day corresponding to maternal plasma levels of tafluprost acid that were 343 times the maximum clinical exposure based on c max . in rabbits, effects were seen at a tafluprost dose of 0.03 mcg/kg/day corresponding to maternal plasma levels of tafluprost acid during organogenesis that were approximately 5 times higher than the clinical exposure based on c max . at the no-effect dose in rabbits (0.01 mcg/kg/day), maternal plasma levels of tafluprost acid were below the lower level of quantification (20 pg/ml). in a pre- and postnatal development study in rats, increased mortality of newborns, decreased body weights and delayed pinna unfolding were observed in offsprings. the no observed adverse effect level was at a tafluprost intravenous dose of 0.3 mcg/kg/day which is greater than 3 times the maximum recommended clinical dose based on body surface area comparison. there are no adequate and well-controlled studies in pregnant woman. although animal reproduction studies are not always predictive of human response, zioptan ® should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. women of childbearing age/potential should have adequate contraceptive measures in place. a study in lactating rats demonstrated that radio-labeled tafluprost and/or its metabolites were excreted in milk. 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 zioptan ® is administered to a nursing woman. use in pediatric patients is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use. no overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients. read these instructions for use before using your zioptan ® and each time you get a refill. there may be new information. this leaflet does not take the place of talking with your doctor about your medical condition or your treatment. important: - zioptan ® is for the eye only. do not swallow zioptan ® . - zioptan ® single-use containers are packaged in a foil pouch. - do not use the zioptan ® single-use containers if the foil pouch is opened. - write down the date you open the foil pouch in the space provided on the pouch. every time you use zioptan ® : - if your doctor has told you to use zioptan ® drops in both eyes, repeat steps 7 to 10 for your other eye. - there is enough zioptan ® in one single-use container for both of your eyes. - throw away the opened single-use container with any remaining zioptan ® right away. this patient information and instructions for use have been approved by the u.s. food and drug administration. rx only manufactured for : thea pharma inc. made in france © 2022. thea pharma inc. all rights reserved the zioptan trademark is owned by merck sharp & dohme corp. and is used under license. revised: 05/22 n10260u30usa/0522

Israel - English - Ministry of Health

rafa laboratories ltd - tafluprost - ophthalmic solution - tafluprost 15 mcg/ml - tafluprost - tafluprost - reduction of elevated intraocular pressure in open angle glaucoma and ocular hypertension.as monotherapy in patients • who would benefit from preservative free eye drops • insufficiently responsive to first line therapy • intolerant or contra-indicated to first line therapyas adjunctive therapy to beta-blockers.

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

the ritedose corporation - tafluprost (unii: 1o6wq6t7g3) (tafluprost - unii:1o6wq6t7g3) -

Malta - English - Medicines Authority

santen oy niittyhaankatu 20, 33720 tampere, finland - tafluprost - eye drops, solution - tafluprost 15 µg/ml - ophthalmologicals