Pays: Malaisie
Langue: anglais
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BIMATOPROST; TIMOLOL MALEATE
ABBVIE SDN BHD
BIMATOPROST; TIMOLOL MALEATE
30 x 0.4 ml; 5 x 0.4ml ml
ALLERGAN PHARMACEUTICALS IRELAND
GANFORT ® PF EYE DROPS bimatoprost (0.3 mg/mL), timolol (5.0 mg/mL) Sterile Ophthalmic Solution Consumer Medication Information Leaflet (RiMUP) What is in this leaflet 1. What GANFORT ® PF is used for 2. How GANFORT ® PF works 3. Before you use GANFORT ® PF 4. How to use GANFORT ® PF 5. While you are using it 6. Side effects 7. Storage and Disposal of GANFORT ® PF 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 1. What GANFORT ® PF is used for GANFORT ® PF is prescribed to reduce high pressure in the eye when other beta blockers or prostaglandin analogues used alone are not enough. 2. How GANFORT ® PF works GANFORT ® PF works by reducing the production of liquid and also increasing the amount of liquid that is drained. This reduces the pressure inside the eye. 3. Before you use GANFORT ® PF - When you must not use it Do not use GANFORT ® PF: - if you are allergic (hypersensitive to bimatoprost and timolol, or any of the other ingredients of GANFORT ® PF. (for a full list of ingredients, see section 8 “PRODUCT DESCRIPTION”). - if you have now or have had in the past respiratory problems such as asthma, severe chronic obstructive bronchitis (severe lung disease which may cause wheeziness, difficulty in breathing and/or long-standing cough). - 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 ® PF if you are pregnant unless your doctor still recommends it. Do not use GANFORT ® PF 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 GANFORT ® PF has only been studied in adults and therefore its use is not recommended in children or adolescents. - Before you start use it Take Lire le document complet
GANFORT ® PF eye drops (bimatoprost 0.3 mg/mL and timolol 5.0 mg/mL) Product Information version 2.0 NAME OF THE MEDICINE GANFORT ® PF Eye Drops PRODUCT DESCRIPTION GANFORT ® PF is a sterile ophthalmic solution in a single-dose container. Each mL of GANFORT ® PF contains: ACTIVES: Bimatoprost 0.3 mg/mL and timolol 5.0 mg/mL EXCIPIENTS: Sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate; and purified water. Hydrochloric acid or sodium hydroxide may be added to adjust pH. _Physical Appearance: _ GANFORT ® PF eye drops is a c lear and colourless solution. _Chemical structure: _ _ _ HO HO OH CON H C 2 H 5 O N N S N O N H H 3 C CH 3 CH 3 H OH HO HO O O _(structure of bimatoprost) _ _ _ _ _ _(structure of timolol maleate) _ CAS Registry No. 155206-00-1 CAS Registry No. 26921-17-5 Bimatoprost is a synthetic prostamide analogue for ophthalmic use. It is a white to off-white powder and is very soluble in ethyl alcohol, methyl alcohol and slightly soluble in water. Timolol maleate is a non-selective beta-adrenergic receptor blocking agent. It is a white, odourless, crystalline powder which is soluble in water, methanol and alcohol. INDICATIONS GANFORT ® PF eye drops are indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues. DOSAGE AND ADMINISTRATION Posology _Recommended dosage in adults (including older people) _ The recommended dose is one drop of GANFORT ® PF 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 ® (multi-dose formulation) 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. GANFORT ® PF eye drops (bimatoprost 0.3 mg/mL and timolol 5.0 mg/mL) P Lire le document complet