Riik: Euroopa Liit
keel: inglise
Allikas: EMA (European Medicines Agency)
travoprost
Novartis Europharm Limited
S01EE04
travoprost
Ophthalmologicals, Antiglaucoma preparations and miotics
Ocular Hypertension; Glaucoma, Open-Angle
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 3 years to < 18 years with ocular hypertension or paediatric glaucoma.
Revision: 6
Authorised
2014-02-20
21 B. PACKAGE LEAFLET 22 PACKAGE LEAFLET : INFORMATION FOR THE USER IZBA 30 MICROGRAMS/ML EYE DROPS, SOLUTION travoprost READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS INFORMATION IMPORTANT FOR YOU - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or 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 IZBA is and what it is used for 2. What you need to know before you use IZBA 3. How to use IZBA 4. Possible side effects 5. How to store IZBA 6. Contents of the pack and other information 1. WHAT IZBA IS AND WHAT IT IS USED FOR IZBA CONTAINS TRAVOPROST, one of a group of medicines called PROSTAGLANDIN ANALOGUES . IZBA IS USED TO REDUCE HIGH PRESSURE IN THE EYE IN ADULTS, ADOLESCENTS AND CHILDREN FROM 3 YEARS OLD ONWARD. This pressure can lead to an illness called GLAUCOMA. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE IZBA DO NOT USE IZBA IF YOU ARE ALLERGIC to travoprost or any of the other ingredients of this medicine (listed in section 6). Ask your doctor for advice if this applies to you. 23 WARNINGS AND PRECAUTIONS IZBA MAY INCREASE the length, thickness, colour and/or number of your EYELASHES. Changes in the eyelids including unusual hair growth or in the tissues around the eye have also been observed. IZBA may gradually CHANGE THE COLOUR OF YOUR IRIS (the coloured part of your eye). This change may be permanent. If you have had cataract surgery talk to your doctor before you use IZBA. IZBA may increase the risk of inflammation of the back of the eye. If you have current or previous history of an eye inflammation (iritis and uveitis) talk to your doctor before you use IZBA. Eye inflammation is a possible side ef Lugege kogu dokumenti
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT IZBA 30 micrograms/mL eye drops, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One mL of solution contains 30 micrograms of travoprost. Excipients with known effect One mL of solution contains 7.5 mg propylene glycol and 2 mg polyoxyethylene hydrogenated castor oil 40 (HCO-40) (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, solution (eye drops). Clear, colourless solution. 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 3 years 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 elderly patients _ 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. 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 IZBA, the other medicinal product should be discontinued and IZBA should be started the following day. 3 _Hepatic and renal impairment _ Travoprost 30 µg/mL has not been studied in patients with hepatic or renal impairment. However, travoprost 40 µg/mL has been studied in patients with mild to severe hepatic impairment and in p Lugege kogu dokumenti