Χώρα: Αυστραλία
Γλώσσα: Αγγλικά
Πηγή: Department of Health (Therapeutic Goods Administration)
latanoprost, Quantity: 50 microgram/mL; timolol maleate, Quantity: 5 mg/mL
Arrotex Pharmaceuticals Pty Ltd
Latanoprost,Timolol maleate
Eye Drops, solution
Excipient Ingredients: benzalkonium chloride; monobasic sodium phosphate monohydrate; water for injections; sodium hydroxide; dibasic sodium phosphate; hydrochloric acid; sodium chloride
Ophthalmic
2.5 mL (in 5 mL bottle)
(S4) Prescription Only Medicine
Reduction of elevated intraocular pressure in patients with open-angle glaucoma and ocular hypertension who are insufficiently responsive to beta-blockers, prostaglandins or other intraocular pressure lowering medications. Latanoprost/Timolol eye drops should not be used to initiate therapy.
Visual Identification: Clear colourless solution, white translucent LDPE bottle, with white translucent LDPE dropper, light yellow opaque HDPE cap with sealing tape; Container Type: Bottle; Container Material: LDPE; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
2014-04-08
APO- LATANOPROST/ TIMOLOL EYE DROPS _Contains the active ingredients Latanoprost 50 mcg/mL and Timolol (as maleate) 5 mg/mL_ CONSUMER MEDICINE INFORMATION FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. This leaflet answers some common questions about latanoprost/timolol eye drops. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available. ASK YOUR DOCTOR OR PHARMACIST: • if there is anything you do not understand in this leaflet, • if you are worried about taking your medicine, or • to obtain the most up-to-date information. You can also download the most up to date leaflet from www.apotex.com.au. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. Keep this leaflet with your medicine. You may want to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is APO- Latanoprost/Timolol eye drops. It contains the active ingredients latanoprost and timolol (as maleate). It is 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 grad Διαβάστε το πλήρες έγγραφο
1 AUSTRALIAN PI – APO-LATANOPROST/TIMOLOL 50/5 (LATANOPROST/TIMOLOL) 1 NAME OF THE MEDICINE Latanoprost and Timolol maleate 2 AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL FORM The active ingredients in APO- Latanoprost/Timolol eye drops are latanoprost and timolol maleate. Latanoprost is a prostaglandin F2α analogue. It has a molecular weight of 432.58. It is a colourless to slightly yellow oil which is practically insoluble in water, freely soluble in ethanol, ethyl acetate, isopropanol, methanol, acetone and octanol, and very soluble in acetonitrile. Sixty four isomers of latanoprost are possible however, for Latanoprost/Timolol eye drops it is purified as a single isomer. Timolol maleate is a beta-adrenergic receptor blocking agent. It has a molecular weight of 432.50. It is a white to off-white crystalline powder which is soluble in water, alcohol and practically insoluble in ether. APO- Latanoprost/Timolol eye drops is a sterile, isotonic solution containing 50 micrograms/mL of latanoprost and 5mg/mL of timolol (6.83mg timolol maleate) in an aqueous buffer solution of pH 6.0. The excipients in the eye drops are sodium chloride, sodium phosphate-monobasic dihydrate, sodium phosphate- dibasic dodecahydrate, purified water and benzalkonium chloride (0.20mg/mL) as a preservative agent with sodium hydroxide or hydrochloric acid for pH adjustment. The solution is a clear and colourless liquid, filled in a polyethylene container. Each 5 mL bottle contains 2.5 mL of the eye drop solution corresponding to a minimum of 80 drops of solution. One drop contains approximately 1.5 µg latanoprost and 150 µg timolol. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Reduction of elevated intraocular pressure in patients with open-angle glaucoma and ocular hypertension who are insufficiently responsive to beta-blockers, prostaglandins or other intraocular pressure lowering medications. Latanoprost/Timolol eye drops should not be used to initiate therapy. 4.2 DOSE AND METHOD OF ADMINISTRATION RECOMME Διαβάστε το πλήρες έγγραφο