travoprost

HOS-093244 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile In clinical trials with TRAVATAN, the most common adverse reactions were ocular hypearemia and iris hyperpigmentation, occurring in approximately 20% and 6% of patients respectively. Tabulated list of adverse reactions The following adverse reactions are classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to<1/1,000), very rare <1/10,000), or not known (frequency cannot be estimated from the available data). Within each frequency group, adverse reactions are presented in decreasing order of seriousness. The adverse reactions were obtained from clinical studies and post- marketing data with TRAVATAN. System Organ Class Frequency Adverse Reactions Immune system disorders Uncommon hypersensitivity, seasonal allergy Psychiatric disorders Not known depression, anxiety, insomnia Nervous system disorder Uncommon headache Rare dizziness, visual field defect, dysgeusia Eye disorders Very common ocular hyperaemia 5  Common iris hyperpigmentation, eye pain, ocular discomfort, dry eye, eye pruritus, eye irritation Uncommon corneal erosion, uveitis, iritis, anterior chamber inflammation, keratitis, punctate keratitis, photophobia, eye discharge , blepharitis, erythema of eyelid, periorbital oedema, eyelids pruritus, visual acuity reduced, vision blurred, lacrimation increased, conjunctivitis, ectropion, cataract, eyelid margin crusting, growth of eyelashes Rare iridocyclitis, ophthalmic herpes simplex, eye inflammation, photopsia, eczema eyelids, conjunctival oedema, halo vision, conjunctival

Auszug; vollständigen Abschnitt im Original lesen.

HOS-093240 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-093239 · has-indication-information · PDF-Seite 2

Decrease of elevated intraocular pressure in adult patients with ocular hypertension or open-angle glaucoma (see section 5.1). Decrease of elevated intraocular pressure in paediatric patients aged 2 months to < 18 years with ocular hypertension or paediatric glaucoma (see section 5.1).

HOS-093242 · has-interaction-information · PDF-Seite 4

No interaction studies have been performed. 4

HOS-093243 · has-pregnancy-information · PDF-Seite 5

Women of child-bearing potential/contraception TRAVATAN must not be used in women of child bearing age/potential unless adequate contraceptive measures are in place (see section 5.3). Pregnancy Travoprost has harmful pharmacological effects on pregnancy and/or the fetus/new-born child. TRAVATAN should not be used during pregnancy unless clearly necessary. Breastfeeding It is unknown whether travoprost from the eye drops is excreted in human breast milk. Animal studies have shown excretion of travoprost and metabolites in breast milk. The use of TRAVATAN by breast-feeding mothers is not recommended. Fertility There are no data on the effects of TRAVATAN on human fertility. Animal studies showed no effect of travoprost on fertility at doses more than 250 times the maximum recommended human ocular dose.

HOS-093241 · has-warning-information · PDF-Seite 3

Eye colour change TRAVATAN may gradually change the eye colour by increasing the number of melanosomes (pigment granules) in melanocytes. Before treatment is instituted, patients must be informed of the possibility of a permanent change in eye colour. Unilateral treatment can result in permanent heterochromia. The long term effects on the melanocytes and any consequences thereof are currently unknown. The change in iris colour occurs slowly and may not be noticeable for months to years. The change in eye colour has predominantly been seen in patients with mixed coloured irides, i.e., blue-brown, grey-brown, yellow-brown and green-brown; however, it has also been observed in patients with brown eyes. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery in affected eyes, but the entire iris or parts of it may be become more brownish. After discontinuation of therapy, no further increase in brown iris pigment has been observed. Periorbital and eye lid changes In controlled clinical trials, periorbital and/or eyelid skin darkening in association with the use of TRAVATAN has been reported in 0.4% of patients. Periorbital and lid changes including deepening of the eyelid sulcus have also been observed with prostaglandin analogues. TRAVATAN may gradually change eyelashes in the treated eye(s); these changes were observed in about half of the patients in clinical trials and include: increased length, thickness, pigmentation, and/or number of lashes. The mechanism of eyelash changes and their long term consequences are currently unknown. TRAVATAN has been shown to cause slight enlargement of the palpebral fissure in studies in the monkey. However, this effect was not observed during the clinical trials and is considered to be species specific. 3 There is no experience of TRAVATAN in inflammatory ocular conditions; nor in neovascular, angle-closure, narrow-angle or congenital glaucoma and only limited experience in thyroid eye disease, in open-angle glaucoma of pseudophakic patients and in pigmentary or pseudoexfoliative glaucoma. TRAVATAN should therefore be used with caution in patients with active intraocular inflammation. Aphakic patients Macular oedema has been reported during treatment with prostaglandin F2a analogues. Caution is recommended when using Travatan in aphakic patients, pseudophakic patients with a torn posterior lens capsule or anterior chamb

Auszug; vollständigen Abschnitt im Original lesen.