Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

nitto medic co., ltd. - tafluprost - limpid and colorless, aqueous ophthalmic solution, 2.5ml, (cap) blue-green, (label) white label with blue-green bands and line and pale red line, (bottle) clear

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.

Malta - English - Medicines Authority

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

Ireland - English - HPRA (Health Products Regulatory Authority)

santen oy - tafluprost - eye drops, solution - 15 microgram(s)/millilitre - tafluprost

Ireland - English - HPRA (Health Products Regulatory Authority)

santen oy - tafluprost - eye drops, solution in single-dose container - 15 microgram(s)/millilitre - prostaglandin analogues1); tafluprost - antiglaucoma preparations and miotics, prostaglandin analogues - 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 therapy. as adjunctive therapy to beta-blockers.

Ireland - English - HPRA (Health Products Regulatory Authority)

pco manufacturing ltd. - tafluprost - eye drops, solution in single-dose container - 15 microgram(s)/millilitre - prostaglandin analogues1); tafluprost

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: santen philippines inc.; distributor: n/a - tafluprost , timolol (as maleate) - ophthalmic solution - 15 mcg/ 5 mg per ml

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

santen oy - tafluprost 0,015 mg/ml - eye drops, solution - 15 µg/ml - tafluprost 15 µg/ml - tafluprost

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

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

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