国: ニュージーランド
言語: 英語
ソース: Medsafe (Medicines Safety Authority)
Bimatoprost 0.1 mg/mL;
Teva Pharma (New Zealand) Limited
Bimatoprost 0.1 mg/mL
0.1 mg/mL
Eye drops, solution
Active: Bimatoprost 0.1 mg/mL Excipient: Benzalkonium chloride Citric acid monohydrate Dibasic sodium phosphate heptahydrate Hydrochloric acid Sodium chloride Sodium hydroxide Water for injection
Prescription
Yonsung Fine Chemicals Co. Limited
Bimatoprost Actavis is indicated as monotherapy for the reduction of elevated intraocular pressure (IOP) in patients with chronic glaucoma or ocular hypertension; or as adjunctive therapy in patients not adequately controlled on other agents.
Package - Contents - Shelf Life: Bottle, plastic, LDPE with LDPE dropper nozzle and HDPE cap - 3 mL - 24 months from date of manufacture stored at or below 25°C 28 days opened stored at or below 25°C
2014-06-30
CONSUMER MEDICINE INFORMATION BIMATOPROST ACTAVIS BIMATOPROST EYE DROPS, SOLUTION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about BIMATOPROST ACTAVIS. 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 BIMATOPROST ACTAVIS 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 BIMATOPROST ACTAVIS IS USED FOR BIMATOPROST ACTAVIS 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. BIMATOPROST ACTAVIS eye drops lower the pressure in the eye by helping the flow of fluid out of the eye chamber. BIMATOPROST ACTAVIS eye drops can be used alone or together with other eye drops/medicines to lower raised pressure within your eyes. Al 完全なドキュメントを読む
Version 1.0 1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME BIMATOPROST ACTAVIS, Eye drops, solution, 0.1 mg/mL and 0.3 mg/mL 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL contains 0.1 mg or 0.3 mg of bimatoprost. Excipient with known effect: benzalkonium chloride For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, solution. BIMATOPROST ACTAVIS is a clear, colourless ophthalmic solution. Bimatoprost is a white to off- white powder and is very soluble in ethyl alcohol and methyl alcohol and slightly soluble in water. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BIMATOPROST ACTAVIS is indicated as monotherapy for the reduction of elevated intraocular pressure (IOP) in patients with chronic glaucoma or ocular hypertension; or as adjunctive therapy in patients not adequately controlled on other agents. 4.2 DOSE AND METHOD OF ADMINISTRATION MONOTHERAPY The recommended dose is one drop of BIMATOPROST ACTAVIS in the affected eye(s) once daily, administered in the evening. ADJUNCTIVE THERAPY The recommended dose is one drop of BIMATOPROST ACTAVIS in the affected eye(s) once daily, administered in the evening. More frequent administration has not been shown to provide increased efficacy. If more than one topical ophthalmic medication is to be used, the other medication should not be used within 5 minutes of using BIMATOPROST ACTAVIS eye drops. In order to minimise systemic absorption of BIMATOPROST ACTAVIS eye drops, patients should be instructed to apply pressure to the tear duct immediately following administration of the drug. PAEDIATRIC USE Safety and effectiveness in patients below 18 years of age have not been established. USE IN ELDERLY No dosage adjustment in elderly patients is necessary. INFORMATION FOR PATIENTS BIMATOPROST ACTAVIS eye drops contain the preservative benzalkonium chloride, which may be absorbed by soft contact lenses. Contact lenses should be removed prior to instillation of BIMATOPROST ACTAVIS and may be reinserted 15 minutes following administration. BIMATO 完全なドキュメントを読む