البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
BIMATOPROST; TIMOLOL AS MALEATE
ABBVIE BIOPHARMACEUTICALS LTD, ISRAEL
S01ED01
EYE DROPS, SOLUTION
BIMATOPROST 0.3 MG/ML; TIMOLOL AS MALEATE 5 MG/ML
OCULAR
Required
ALLERGAN PHARMACEUTICALS IRELAND
TIMOLOL
TIMOLOL
Reduction of intraocular pressure in patients with open- angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.
2015-06-30
Page 1 of 7 GAN APL TIK JUN 23 CL PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only GANFORT ® EYE DROPS ACTIVE INGREDIENTS AND ITS CONCENTRATION: bimatoprost 0.03% w/v and timolol (as maleate) 0.5% w/v Inactive ingredients and allergens in this medicine: See section 2 under "Important information about some of this medicine’s ingredients" and section 6 "Additional information". READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed to treat your illness/for you. Do not pass it on to others. It may harm them, even if it seems to you that their illness/medical condition is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? Ganfort is used to reduce pressure in the eyes of patients who have open-angle glaucoma or high pressure in the eye and whose response to local treatment with beta-blockers or prostaglandin analogues has been insufficient. THERAPEUTIC GROUP: timolol - beta-blockers, bimatoprost - prostamides, prostaglandin analogues. This medicine contains two different active ingredients that both reduce pressure in the eye. Bimatoprost belongs to a group of medicines called prostamides, a prostaglandin analogue. Timolol belongs to a group of medicines called beta-blockers. Your eye contains a clear, watery liquid that feeds the inside of the eye. The liquid is constantly being drained out of the eye and new liquid is made to replace this. If the liquid cannot drain out quickly enough, the pressure inside the eye builds up and could eventually damage your vision (an illness called glaucoma). Ganfort works by reducing the production of liquid and also increasing the amount of liquid that is drained. This reduces the pressure inside the eye. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: − You are sensitive (aller اقرأ الوثيقة كاملة
GAN API MAR 23 CL Page 1 of 12 1. NAME OF THE MEDICINAL PRODUCT GANFORT ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION bimatoprost 0.03% w/v and timolol (as maleate) 0.5% w/v. Excipient with known effect Each ml of solution contains 0.05 mg of benzalkonium chloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops. Colourless to slightly yellow solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Recommended dosage in adults (including older people_ _)_ The recommended dose is one drop of GANFORT in the affected eye(s) once daily, administered either in the morning or in the evening. It should be administered at the same time each day. Existing literature data for GANFORT suggest that evening dosing may be more effective in IOP lowering than morning dosing. However, consideration should be given to the likelihood of compliance when considering either morning or evening dosing (see section 5.1). 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. _Renal and hepatic _ _impairment_ GANFORT has not been studied in patients with hepatic or renal impairment. Therefore caution should be used in treating such patients. _Paediatric _ _population_ GAN API MAR 23 CL Page 2 of 12 The safety and efficacy of GANFORT in children aged 0 to 18 years has not been established. No data are available. Method of administration If more than one topical ophthalmic medicinal product is to be used, each one should be instilled at least 5 minutes apart. When using nasolacrimal occlusion or closing the eyelids for 2 minutes, the systemic absorption is reduced. This may result in a decrease in systemic side effects and an increase in local activity. 4.3 CONTRAINDICATIONS ▪ Hyp اقرأ الوثيقة كاملة