Pajjiż: Malasja
Lingwa: Ingliż
Sors: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BIMATOPROST
ABBVIE SDN BHD
BIMATOPROST
3ml mL
ALLERGAN PHARMACEUTICALS IRELAND
LUMIGAN ® 0.01% bimatoprost (0.01%) ophthalmic solution 1 Consumer Medication Information Leaflet (RiMUP) What is in this leaflet 1. What LUMIGAN ® 0.01% is used for 2. How LUMIGAN ® 0.01% works 3. Before you use LUMIGAN ® 0.01% 4. How to use LUMIGAN ® 0.01% 5. While you are using it 6. Side effects 7. Storage and Disposal of LUMIGAN ® 0.01% 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 1. What LUMIGAN ® 0.01% is used for LUMIGAN ® 0.01% is used to reduce high pressure in the eye. 2. How LUMIGAN ® 0.01% works LUMIGAN ® 0.01% increases the amount of fluid flowing out of the eye which reduces the internal eye pressure. 3. Before you use LUMIGAN ® 0.01% - When you must not use it Do not use LUMIGAN ® 0.01%: - if you are allergic (hypersensitive to bimatoprost, or any of the other ingredients of LUMIGAN ® 0.01%. (for a full list of ingredients, see section 8 “PRODUCT DESCRIPTION”). - if you have had to stop using eye drops in the past because of a side effect of the preservative benzalkonium chloride - Pregnancy and lactation If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not use LUMIGAN ® 0.01% if you are pregnant unless your doctor still recommends it. LUMIGAN ® 0.01% may get into breast milk so you should not breast- feed while you are taking LUMIGAN ® 0.01%. Children: LUMIGAN ® 0.01% has not been tested in children under the age of 18 and therefore must not be used by patients under 18 years. - Before you start to use it Take special care with LUMIGAN ® 0.01%. Talk to you doctor if: - You have any eye surgery or suffered trauma or infection to the eye. - You have breathing problems - You have liver or kidney problems - You have dry eyes - You have or have had any problems with your cornea (front transparent part of the eye) - You wear contact lenses - You have or had low blood pressure or low heart rate - You have had a viral Aqra d-dokument sħiħ
LUMIGAN® 0.01% (BIMATOPROST OPHTHALMIC SOLUTION) 1 DESCRIPTION LUMIGAN® 0.01% (bimatoprost ophthalmic solution) is a synthetic prostamide analog with ocular hypotensive activity. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(1E,3S)-3- hydroxy-5-phenyl-1-pentenyl]cyclopentyl]-5-N-ethylheptenamide, and its molecular weight is 415.58. Its molecular formula is C25H37NO4. Its chemical structure is: Bimatoprost is a powder, which is very soluble in ethyl alcohol and methyl alcohol and slightly soluble in water. LUMIGAN® 0.01% is a clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol/kg. LUMIGAN® 0.01% contains Active: bimatoprost 0.1 mg/mL; Preservative: benzalkonium chloride 0.2 mg/mL; Inactives: sodium chloride; sodium phosphate, dibasic; citric acid; and purified water. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. The pH during its shelf life ranges from 6.8-7.8. 2 INDICATIONS AND USAGE LUMIGAN® 0.01% (bimatoprost ophthalmic solution) is indicated for the reduction of elevated intraocular pressure in chronic open-angle glaucoma and ocular hypertension in adults (as monotherapy or as adjunctive therapy to beta-blockers). 3 DOSAGE AND ADMINISTRATION Dosage The recommended dosage 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 eye drops, solution had no adverse effect on liver function o Aqra d-dokument sħiħ