Country: Израел
Језик: Енглески
Извор: Ministry of Health
TIMOLOL AS MALEATE; TRAVOPROST
NOVARTIS ISRAEL LTD
S01ED51
OPHTHALMIC SOLUTION
TRAVOPROST 40 MCG/ML; TIMOLOL AS MALEATE 5 MG/ML
OCULAR
Required
ALCON COUVREUR, BELGIUM
TIMOLOL, COMBINATIONS
TIMOLOL, COMBINATIONS
Decrease of intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.
2015-09-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only DUOTRAV ® EYE DROPS (SOLUTION) COMPOSITION: Active ingredients: Travoprost 40 mcg/mL Timolol as maleate 5 mg/mL For the list of inactive ingredients in the preparation see section 6 - “Further Information” and section 2 – “Important information regarding some of the ingredients of the medicine”. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. Keep this leaflet; you may need to read it again. This medicine has been prescribed for the treatment of your ailment. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? To reduce intraocular pressure in cases of open-angle glaucoma or intraocular hypertension that are insufficiently responsive to topical beta blockers or prostaglandin analogs. THERAPEUTIC GROUP: Travoprost – prostaglandin analog, which works by increasing the outflow of aqueous fluid from the eye, thereby lowering ocular pressure. Timolol (as maleate) – beta blocker, which works by reducing the production of fluid within the eye. The two substances work together to reduce pressure within the eye. 2. BEFORE USING THE MEDICINE X DO NOT USE THIS MEDICINE IF: ∙ You are sensitive (allergic) to travoprost, prostaglandins, timolol, beta blockers or to any of the other ingredients of the medicine (as detailed in section 6). ∙ You are breastfeeding. ∙ You are suffering, or have suffered in the past, from breathing problems, such as asthma or severe chronic bronchitis (a severe lung disease that may cause wheezing, breathing difficulties and/or persistent cough) or other breathing problems. ∙ You suffer from severe hay fever. ∙ You have a slow heart rate, heart failure or arrhythmia (irregular Прочитајте комплетан документ
DUO API DEC20 V 3 EU SmPC Oct2020 1. NAME OF THE MEDICINAL PRODUCT DuoTrav 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of solution contains 40 micrograms of travoprost and 5 mg of timolol (as timolol maleate). Excipient(s) with known effect: Each ml of solution contains polyquaternium-1 (POLYQUAD) 10 microgram, propylene glycol 7.5 mg, polyoxyethylene hydrogenated castor oil 40 1.0 mg (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Ophthalmic solution (eye drops). Clear, colourless solution 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Decrease of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues (see section- 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Use in adults, including the elderly The dose is one drop of DuoTrav in the conjunctival sac of the affected eye(s) once daily, in the morning or evening. It should be administered at the same time each day. 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. SPECIAL POPULATIONS Hepatic and renal impairment No studies have been conducted with DuoTrav or with timolol 5 mg/ml eye drops in patients with hepatic or renal impairment. Travoprost has been studied in patients with mild to severe hepatic impairment and in patients with mild to severe renal impairment (creatinine clearance as low as 14 mL/min). No dose adjustment was necessary in these patients. Patients with hepatic or renal impairment are unlikely to require dose adjustment with DuoTrav (see section 5.2). Paediatric population The safety and efficacy of DuoTrav in children and adolescents below the age of 18 years have not been established. No data are available. Method of administration For DUO API DEC20 V 3 EU SmPC Oct2020 ocular use. The patient should remove the protective overwrap immediately prior to initial use. T Прочитајте комплетан документ