Maa: Malesia
Kieli: englanti
Lähde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BIMATOPROST; TIMOLOL MALEATE
ABBVIE SDN BHD
BIMATOPROST; TIMOLOL MALEATE
3ml mL
ALLERGAN PHARMACEUTICALS IRELAND
GANFORT ® EYE DROPS Bimatoprost/timolol (0.3mg/5.0mg per ml) 1 Consumer Medication Information Leaflet (RiMUP) What is in this leaflet 1. What GANFORT ® is used for 2. How GANFORT ® works 3. Before you use GANFORT ® 4. How to use GANFORT ® 5. While you are using it 6. Side effects 7. Storage and Disposal of GANFORT ® 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision What GANFORT ® is used for GANFORT ® is prescribed to lower the pressure in the eye of people with glaucoma or high pressure in the eye when other medicines like beta blockers or prostaglandin analogues used alone are not enough. How GANFORT ® works 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. Before you use GANFORT ® - When you must not use it Do not use GANFORT ® : - if you are allergic (hypersensitive to bimatoprost or timolol, or any of the other ingredients of GANFORT ® . (for a full list of ingredients, see section “PRODUCT DESCRIPTION”). - if you have now or have had in the past respiratory problems such as asthma, severe chronic obstructive lung disease. - if you have heart problems such as low heart rate, heart failure, heart beat disorders (unless controlled by a pacemaker). - 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 GANFORT ® if you are pregnant unless your doctor still recommends it. Do not use GANFORT ® if you are breast-feeding. Timolol may get into your breast milk. Ask your doctor for advice before taking any medicine during breast-feeding. - Children and adolescents GANFORT ® has only been studied in adults and therefore its use is not recommended in children or adolescents. - Before you start to use it Take special care with GANFORT ® . Always use GANFORT ® exactly as your doctor or pharmacist has told you. Lue koko asiakirja
GANFORT® eye drops, solution Bimatoprost 0.3 mg/mL and timolol 5.0 mg/mL DESCRIPTION Each mL contains: 0.3 mg bimatoprost and 5 mg timolol equivalent to 6.8 mg of timolol maleate, benzalkonium chloride as preservative, sodium chloride, dibasic sodium phosphate heptahydrate, citric acid monohydrate, hydrochloric acid or sodium hydroxide (to adjust pH), purified water. CLINICAL PHARMACOLOGY PHARMACODYNAMIC PROPERTIES _Pharmacotherapeutic group:_ Ophthalmological – beta-blocking agents – timolol, combinations ATC code: SO1ED 51 _Mechanism of action:_ GANFORT® consists of two active substances: bimatoprost and timolol maleate. These two components decrease elevated intraocular pressure (IOP) by complementary mechanisms of action and the combined effect results in additional IOP reduction compared to either compound administered alone. GANFORT® has a rapid onset of action. Bimatoprost is a potent ocular hypotensive agent. It is a synthetic prostamide, structurally related to prostaglandin F2 α (PGF2 α ) that acts through an identified prostamide receptor. The mechanism of action by which bimatoprost reduces intraocular pressure in man is by increasing aqueous humour outflow through the trabecular meshwork and enhancing uveoscleral outflow. Timolol is a beta 1 and beta 2 non-selective adrenergic receptor blocking agent that does no t h ave significant intrinsic sympathomimetic, direct myocardial depressant, or local anaesthetic (membrane ‑ stabilising) activity. Timolol lowers IOP by reducing aqueous humour formation. The precise mechanism of action is not clearly established, but inhibition of the increased cyclic AMP synthesis caused by endogenous beta-adrenergic stimulation is probable. _Clinical effects:_ The IOP-lowering effect of GANFORT® is non-inferior to that achieved by adjunctive therapy of bimatoprost (once daily) and timolol (twice daily). Existing literature data for GANFORT® suggest that evening dosing may be more effective in IOP lowering than morning dosing. However, consideration should b Lue koko asiakirja