Χώρα: Αυστραλία
Γλώσσα: Αγγλικά
Πηγή: Department of Health (Therapeutic Goods Administration)
travoprost, Quantity: 40 microgram/mL
Novartis Pharmaceuticals Australia Pty Ltd
Travoprost
Eye Drops, solution
Excipient Ingredients: boric acid; ethoxylated hydrogenated castor oil; polyquaternium-1; sodium hydroxide; mannitol; hydrochloric acid; propylene glycol; purified water; sodium chloride
Ophthalmic
2.5 mL x 1, 2.5 mL x 3
(S4) Prescription Only Medicine
TRAVATAN Eye Drops are indicated to decrease elevated intraocular pressure in: - ocular hypertension. - open-angle glaucoma. TRAVATAN Eye Drops may be used: - as first line monotherapy. - as adjunctive therapy.
Visual Identification: Clear colourless, sterile and preserved solution; Container Type: Bottle; Container Material: PP; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2011-07-27
TRAVATAN ® _EYE DROPS 0.004%_ _travoprost_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE YOU START TO USE TRAVATAN EYE DROPS. This leaflet answers some common questions about Travatan 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 final page. More recent information on the medicine may be available. YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO OBTAIN THE MOST UP TO DATE INFORMATION ON THE MEDICINE. YOU CAN ALSO DOWNLOAD THE MOST UP TO DATE LEAFLET IN AUSTRALIA FROM WWW.NOVARTIS.COM.AU OR WWW.MEDSAFE.GOVT.NZ IN NEW ZEALAND. The updates may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the risks of you using Travatan against the expected benefits it will have for you. The information in this leaflet applies to Travatan Eye Drops only. This information does not apply to similar products, even if they contain the same ingredients. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT TRAVATAN IS USED FOR Travatan Eye Drops contain the active ingredient travoprost, which belongs to a class of medicines known as "prostaglandins". Travatan Eye Drops are used, either alone or in combination with other eye drops/medicines, to lower raised pressure in the eye and to treat glaucoma. Glaucoma is usually caused by a build-up of the fluid which flows through the eye, leading to an increase in the pressure within the eye; some people with glaucoma may, however, have normal pressure within the eye. Travatan Eye Drops lower the pressure within the eye by increasing the outflow of fluid from the eye. Although Travatan Eye Drops help to control your glaucoma, it does not cure it. Before prescribing Travatan Διαβάστε το πλήρες έγγραφο
1 AUSTRALIAN PRODUCT INFORMATION – TRAVATAN 0.004% (TRAVOPROST) EYE DROPS SOLUTION 1 NAME OF THE MEDICINE Travoprost 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 TRAVATAN 0.004% EYE DROPS CONTAIN 40 ΜG/ML TRAVOPROST.PHARMACEUTICAL FORM Eye drops, solution. TRAVATAN Eye Drops is a clear, colourless, sterile and preserved solution. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS TRAVATAN Eye Drops are indicated to decrease elevated intraocular pressure in: • ocular hypertension • open angle glaucoma TRAVATAN Eye Drops may be used: • as first line monotherapy • as adjunctive therapy 4.2 D OSE AND METHOD OF ADMINISTRATION Instil one drop of TRAVATAN Eye Drops in the conjunctival sac of the affected eye(s) each day. Optimal effect is obtained if the dose is administered in the evening. If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart. When substituting another ophthalmic anti glaucoma agent with TRAVATAN Eye Drops, discontinue the other agent and start the following day with TRAVATAN Eye Drops. INSTRUCTIONS FOR PATIENTS In accordance with good clinical practice for the administration of eye drops, patients should be instructed to gently occlude the nasolacrimal ducts for two minutes after instillation. Discard container 4 weeks after opening. 2 4.3 C ONTRAINDICATIONS TRAVATAN Eye Drops are contraindicated in patients with a known hypersensitivity to travoprost or any of the excipients in the product (see Section 6.1 List of Excipients). TRAVATAN Eye Drops are also contraindicated in pregnant women or women attempting to become pregnant (see Section 4.6 Fertility, Pregnancy and Lactation). 4.4 S PECIAL WARNINGS AND PRECAUTIONS FOR USE NOT FOR INJECTION OR ORAL INGESTION TRAVATAN Eye Drops have not been studied in patients with narrow angle glaucoma. EYE COLOUR CHANGES TRAVATAN Eye Drops may gradually change the eye colour by increasing the number of melanosomes (pigment granules) in melanocytes. Before treatment is instituted Διαβάστε το πλήρες έγγραφο