País: Países Bajos
Idioma: neerlandés
Fuente: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
TRAVOPROST 40 µg/ml
Pharmathen S.A. 6, Dervanakion St. 153 51 PALLINI ATTICA (GRIEKENLAND)
S01EE04
TRAVOPROST 40 µg/ml
Oogdruppels, oplossing
BENZALKONIUMCHLORIDE ; BOORZUUR (E 284) ; DINATRIUMEDETAAT 2-WATER ; MACROGOLGLYCEROLHYDROXYSTEARAAT ; MANNITOL (D-) (E 421) ; NATRIUMHYDROXIDE (E 524) ; TROMETAMOL ; WATER VOOR INJECTIE,
Oculair gebruik
Travoprost
Hulpstoffen: BENZALKONIUMCHLORIDE; BOORZUUR (E 284); DINATRIUMEDETAAT 2-WATER; MACROGOLGLYCEROLHYDROXYSTEARAAT; MANNITOL (D-) (E 421); NATRIUMHYDROXIDE (E 524); TROMETAMOL; WATER VOOR INJECTIE;
2014-04-28
PACKAGE LEAFLET: INFORMATION FOR THE USER TRAVOPROST PHARMATHEN 40 MICROGRAM/ML, OOGDRUPPELS, OPLOSSING Travoprost READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or your pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What [Travoprost] is and what it is used for 2. What you need to know before you use [Travoprost] 3. How to use [Travoprost] 4. Possible side effects 5. How to store [Travoprost] 6. Contents of the pack and other information 1. WHAT [TRAVOPROST] IS AND WHAT IT IS USED FOR [Travoprost] eye drops are used to treat high pressure in the eye. This pressure can lead to an illness called GLAUCOMA. HIGH PRESSURE IN THE EYE. Your eyeballs contain a clear, watery liquid which feeds the inside of the eye. Liquid is always emptying out of the eye, and more liquid is always being produced. If the eye fills up faster than it empties, the pressure inside the eye builds up. If it gets too high, it can damage your sight. [Travoprost] is one of a group of medicines for glaucoma called prostaglandin analogues. It works by increasing the outflow of liquid, which lowers the pressure in the eye. It may be used on its own or with other drops e.g. beta-blockers, which also reduce pressure. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE [TRAVOPROST] DO NOT USE [TRAVOPROST] if you are allergic to travoprost or any of the other ingredients of this medicine (listed in section 6) WARNINGS AND PRECAUTIONS IF YOU ARE UNDER 18. [Travoprost] is not to be used by people under 18 years of age. [Travoprost] may: increase the length, thickness, colour and/or n Leer el documento completo
1. NAME OF THE MEDICINAL PRODUCT Travoprost Pharmathen40 micrograms/mL eye drops, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 mL of solution contains 40 micrograms of travoprost. Average active substance/drop: 0.97 - 1.4 μg Excipients with known effect benzalkonium chloride 150 micrograms/mL, macrogolglycerol hydroxystearate 40 5 mg/mL (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, solution. Clear, colourless solution. pH: 5.5-7.0 Osmolality: 266-294 mOsm/Kg 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Use in adults, including the elderly population _ The dose is one drop of [Travoprost] in the conjunctival sac of the affected eye(s) once daily. Optimal effect is obtained if the dose is administered in the evening. Nasolacrimal occlusion or gently closing the eyelid after administration is recommended. This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic adverse reactions. If more than one topical ophthalmic medicinal product is being used, the medicinal products must be administered at least 5 minutes apart (see section 4.5). If a dose is missed, treatment should be continued with the next dose as planned. The dose should not exceed one drop in the affected eye(s) daily. When substituting another ophthalmic antiglaucoma medicinal product with [Travoprost], the other medicinal product should be discontinued and [Travoprost] should be started the following day. _Hepatic and renal impairment _ Travoprost has been studied in patients with mild to severe hepatic impairment and in patients with mild to severe renal impairment (creat Leer el documento completo