מדינה: הולנד
שפה: הולנדית
מקור: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
LATANOPROST ; TIMOLOLMALEAAT SAMENSTELLING overeenkomend met ; TIMOLOL 0-WATER
Apotex Europe BV Archimedesweg 2 2333 CN LEIDEN
S01ED51
LATANOPROST ; TIMOLOLMALEAAT COMPOSITION corresponding to ; TIMOLOL 0-WATER
Oogdruppels, oplossing
BENZALKONIUMCHLORIDE ; DINATRIUMWATERSTOFFOSFAAT 0-WATER (E 339) ; NATRIUMCHLORIDE ; NATRIUMDIWATERSTOFFOSFAAT 1-WATER (E 339) ; NATRIUMHYDROXIDE (E 524) ; WATER VOOR INJECTIE ; ZOUTZUUR (E 507),
Oculair gebruik
Timolol, Combinations
Hulpstoffen: BENZALKONIUMCHLORIDE; DINATRIUMWATERSTOFFOSFAAT 0-WATER (E 339); NATRIUMCHLORIDE; NATRIUMDIWATERSTOFFOSFAAT 1-WATER (E 339); NATRIUMHYDROXIDE (E 524); WATER VOOR INJECTIE; ZOUTZUUR (E 507);
2014-09-16
LATANOPROST/TIMOLOL APOTEX 50 MICROGRAM/ML + 5 MG/ML OOGDRUPPELS, OPLOSSING MODULE 1.3 Product Information- NL Version: 2019-08 MODULE 1.3.1 Package Leaflet Replaces : 2017-12-18 1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LATANOPROST/TIMOLOL APOTEX 50 MICROGRAM/ML + 5 MG/ML OOGDRUPPELS, OPLOSSING latanoprost + timolol 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 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 Latanoprost/Timolol Apotex is and what it is used for 2. What you need to know before you use Latanoprost/Timolol Apotex 3. How to use Latanoprost/Timolol Apotex 4. Possible side effects 5. How to store Latanoprost/Timolol Apotex 6. Contents of the pack and other information 1. WHAT LATANOPROST/TIMOLOL APOTEX IS AND WHAT IT IS USED FOR Latanoprost/Timolol Apotex contains two medicines: latanoprost and timolol. Latanoprost belongs to a group of medicines known as prostaglandin analogues. Timolol belongs to a group of medicines known as beta-blockers. Latanoprost works by increasing the natural outflow of fluid from the eye into the bloodstream. Timolol works by slowing the formation of fluid in the eye. Latanoprost/Timolol Apotex is used to reduce the pressure in your eye if you have conditions known as open angle glaucoma or ocular hypertension. Both these conditions are linked to an increase in the pressure within your eye, eventually affecting your eyesight. Your doctor will usually prescribe you this medicine when other medicines have not worked adequately. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE LATANOPROST/TIMOLOL APOT קרא את המסמך השלם
LATANOPROST/TIMOLOL APOTEX 50 MICROGRAM/ML + 5 MG/ML OOGDRUPPELS, OPLOSSING MODULE 1.3 Product Information - NL Version: 2019-08 MODULE 1.3.1 Summary of Product Characteristics Replaces : 2017-12- 18 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Latanoprost/Timolol Apotex 50 microgram/ml + 5 mg/ml oogdruppels, oplossing 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution contains latanoprost 50 micrograms and timolol maleate 6.8 mg equivalent to 5 mg timolol. Each drop contains approximately 1.44 micrograms latanoprost and 144 micrograms timolol. Excipient with known effect: Benzalkonium chloride 200 microgram/ml. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, solution. Clear, colourless solution of approximately pH 6.0 and 290 mOsmols/L. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Latanoprost/Timolol is indicated in adults (including the elderly) for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma and ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ Posology ADULTS (INCLUDING THE ELDERLY) _ _ Recommended therapy is one eye drop in the affected eye(s) once daily. LATANOPROST/TIMOLOL APOTEX 50 MICROGRAM/ML + 5 MG/ML OOGDRUPPELS, OPLOSSING MODULE 1.3 Product Information - NL Version: 2019-08 MODULE 1.3.1 Summary of Product Characteristics Replaces : 2017-12- 18 2 If one dose is missed, treatment should continue with the next dose as planned. The dose should not exceed one drop in the affected eye(s) daily. _ _ _Paediatric population _ The safety and efficacy of Latanoprost/Timolol in children and adolescents has not been established. _ _ _Method of Administration: _ Contact lenses should be removed before instillation of the eye drops and may be reinserted after 15 minutes (see section 4.4). If more than one topical ophthalmic drug is being used, the drugs should be administered at least 5 minutes apart. Wh קרא את המסמך השלם