البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
BIMATOPROST
ALLERGAN ISRAEL LTD
S01EE03
OPHTHALMIC SOLUTION
BIMATOPROST 0.3 MG/ML
OCULAR
Required
ALLERGAN INC., USA
BIMATOPROST
BIMATOPROST
Reduction of elevated intraocular pressure in chronic open angle glaucoma and ocular hypertension (as monotherapy or as adjunctive therapy to beta-blockers).
2012-04-30
1 PATIENT PACKAGE LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The dispensing of this medicine requires a doctor's prescription LUMIGAN SOLUTION FOR EYE TREATMENT ACTIVE INGREDIENT: bimatoprost 0.3 mg/ml 0.03% ) ) Inactive ingredients and allergens in the medicine: see Section 2, in the subsection "Important information about some of the ingredients of LUMIGAN" and Section 6, "FURTHER INFORMATION". 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. 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 ailment is similar. 1. WHAT IS THIS MEDICINE INTENDED FOR? Lumigan is intended for reducing pressure in the eye in patients with chronic open-angle glaucoma. It is used on its own or together with drops which contain beta-blockers. THERAPEUTIC GROUP: prostaglandin analogues called prostamides. 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. This medicine works by increasing the amount of liquid that is drained. This reduces the pressure inside the eye. If the high pressure is not reduced, it could lead to a disease called glaucoma and eventually damage your sight. 2. BEFORE USING THE MEDICINE _ _ SPECIAL WARNINGS REGARDING USE OF THIS MEDICINE BEFORE BEGINNING TREATMENT WITH LUMIGAN, TELL THE DOCTOR IF: • You have any breathing problems • You have liver or kidney problems • You have had a cataract surgery in the past • You have dry eye • You have or have had any problems with your cornea (front transparent part of the eye) DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to bimatoprost or to any of the other ingre اقرأ الوثيقة كاملة
Lumigan IL SPC 03.2019-Notification Page 1 of 7 _The format of this leaflet was determined by the Ministry of Health and its content was checked and _ _approved by the Ministry of Health in December 2016_ _and updated according to the Ministry of _ _Health`s guidelines in March 2019 _ PHYSICIAN’S PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT LUMIGAN 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of solution contains 0.3 mg bimatoprost. Excipient with known effect: One ml of solution contains 0.05 mg benzalkonium chloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Ophthalmic solution. Colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Reduction of elevated intraocular pressure in chronic open-angle glaucoma and ocular hypertension in adults (as monotherapy or as adjunctive therapy to beta-blockers). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is one drop in the affected eye(s) once daily, administered in the evening. The dose should not exceed once daily as more frequent administration may lessen the intraocular pressure lowering effect. _Paediatric population_: The safety and efficacy of LUMIGAN in children aged 0 to 18 years has not yet been established. Patients with hepatic and renal impairment: LUMIGAN has not been studied in patients with renal or moderate to severe hepatic impairment and should therefore be used with caution in such patients. In patients with a history of mild liver disease or abnormal alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin at baseline, bimatoprost 0.3 mg/ml ophthalmic solution had no adverse effect on liver function over 24 months. Method of administration If more than one topical ophthalmic medicinal product is being used, each one should be administered at least 5 minutes apart. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. LUMIGAN 0.3 mg/ml is contraindicated in patients who have h اقرأ الوثيقة كاملة