Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
timolol maleate, Quantity: 6.8 mg/mL (Equivalent: timolol, Qty 5 mg/mL); bimatoprost, Quantity: 300 microgram/mL
Abbvie Pty Ltd
Bimatoprost,Timolol maleate
Eye Drops, solution
Excipient Ingredients: dibasic sodium phosphate heptahydrate; hydrochloric acid; citric acid monohydrate; purified water; sodium chloride; sodium hydroxide
Topical
10 x 0.4 mL unit dose ampoule, 5 x 0.4 mL unit dose ampoule, 30 x 0.4 mL unit dose ampoule
(S4) Prescription Only Medicine
GANFORT PF 0.3/5 eye drops are indicated for the reduction of intraocular pressure (IOP) in patients with chronic open-angle glaucoma or ocular hypertension who are insufficiently responsive to monotherapy.
Visual Identification: Clear, colourless sterile ophthalmic solution.; Container Type: Ampoule; Container Material: LDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2013-11-13
GANFORT ® PF 0.3/5 bimatoprost 0.3 mg per mL & timolol (as maleate) 5.0 mg per mL Eye Drops CMIv4 GANFORT ® PF 0.3/5 EYE DROPS (BIMATOPROST 0.3 MG PER ML AND TIMOLOL (AS MALEATE) 5.0 MG PER ML) CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about GANFORT ® PF 0.3/5 eye drops. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using GANFORT ® PF 0.3/5 eye drops against the benefits they expect it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. KEEP THIS LEAFLET WITH THE MEDICINE. YOU MAY NEED TO READ IT AGAIN. WHAT GANFORT ® PF 0.3/5 EYE DROPS ARE USED FOR GANFORT ® PF 0.3/5 eye drops are used to lower raised pressure in the eye and to treat glaucoma. Glaucoma is a condition in which the pressure of fluid in the eye may be high. However, some people with glaucoma may have normal eye pressure. Glaucoma is usually caused by a build up of the fluid which flows through the eye. This build up occurs because the fluid drains out of your eye more slowly than it is being pumped in. Since new fluid continues to enter the eye, joining the fluid already there, the pressure continues to rise. This raised pressure may damage the back of the eye resulting in gradual loss of sight. Damage can progress so slowly that the person is not aware of this gradual loss of sight. Sometimes even normal eye pressure is associated with damage to the back of the eye. There are usually no symptoms of glaucoma. The only way of knowing that you have glaucoma is to have your eye pressure, optic nerve and visual field checked by an eye specialist or optometrist. If glaucoma is not treated it can lead to serious problems, including total blindness. In fact, untreated glaucoma is one of the most common causes of blindness. GANFORT ® PF 0.3/5 eye drops lower the pressure in the eye by decreasing Przeczytaj cały dokument
GANFORT ® PF PI v7 CCDS v4 1 AUSTRALIAN PRODUCT INFORMATION GANFORT ® PF 0.3/5 (BIMATOPROST AND TIMOLOL (AS MALEATE)) EYE DROPS 1 NAME OF THE MEDICINE Bimatoprost and Timolol (as maleate) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Bimatoprost 0.3 mg/mL and Timolol (as maleate) 5.0 mg/mL For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Eye drops, solution. Clear, colourless sterile ophthalmic solution. Contains no antimicrobial agent. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS GANFORT ® PF 0.3/5 eye drops are indicated for the reduction of intraocular pressure (IOP) in patients with chronic open-angle glaucoma or ocular hypertension who are insufficiently responsive to monotherapy. 4.2 DOSE AND METHOD OF ADMINISTRATION The recommended dose is one drop of GANFORT ® PF 0.3/5 in the affected eye(s) once daily, administered in the morning. In order to minimise systemic absorption of GANFORT ® PF 0.3/5 eye drops, apply pressure to the tear duct for at least 2 minutes immediately following administration of the drug (SEE PRECAUTIONS) . If more than one topical ophthalmic medicinal product is to be used, each one should be instilled at least 5 minutes apart. The unit dose container is for single use only; one container is sufficient to treat both eyes. Any unused solution should be discarded immediately after use. 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. INFORMATION FOR PATIENTS - USE WITH CONTACT LENSES: Patients wearing soft (hydrophilic) contact lenses should be instructed to remove them prior to administration of GANFORT® PF 0.3/5 and wait at least 15 minutes after instilling GANFORT® PF 0.3/5 before reinserting soft contact lenses. Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures to avoid eye injury and contamination of eye drops. GANFORT ® PF PI v7 CCDS v4 2 4.3 CONTRAINDICATI Przeczytaj cały dokument