국가: 말레이시아
언어: 영어
출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TRAVOPROST
Gopharma Sdn. Bhd.
TRAVOPROST
2.5ml mL
Micro Labs Limited
TRAVO EYE DROPS 0.004% w/v Consumer Medication Information Leaflet (RiMUP) Travoprost 0.004% w/v Eye drops, solution 1 What is in this leaflet? 1. What Travo Eye Drops 0.004% w/v is used for 2. How Travo works 3. Before you use Travo 4. How to use Travo 5. While you are using it 6. Side effects 7. Storage and Disposal of Travo 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision What Travo Eye Drops 0.004% w/v is used for Travoprost Eye Drops 0.004% w/v is used to reduce high pressure in the eye in adults. This pressure can lead to an illness called glaucoma. How Travo works Travo contains Travoprost, one of a group of medicines called prostaglandin analogues. It works by reducing the pressure in the eye. It may be used on its own or with other drops e.g. beta ‑ blockers, which also reduce pressure. Before you use Travo - When you must not use it • If you are allergic to Travoprost or any of the other ingredients of this medicine. Ask your doctor for advice if this applies to you. Pregnancy and lactation Do not take Travo if you are pregnant, trying to get pregnant or think you may be pregnant. Do not take Travo if you are breast- feeding. Ask your doctor or pharmacist for advice before taking any medicine. - Before you start use it Before you take this medicine, tell your doctor: You are taking any other medicines obtained without a prescription. You wear contact lenses. - Taking other medicines Tell your doctor or pharmacist if you are taking or have recently taken or used any other medicines. How to use Travo Always use this medicine exactly as your doctor or the doctor treating your child has told you. You should check with your doctor, the doctor treating your child or pharmacist if you are not sure. - How much to use One drop in the affected eye or eyes, once a day in the evening If a drop misses the eye, try again. - When to use it Travo should be used once a day, in the evening. - How long to use it Only use Travoprost in both eyes if your doctor told you 전체 문서 읽기
TRAVO 0.004% W/V EYE DROPS TRAVOPROST 0.004% W/V EYE DROPS, SOLUTION NAME AND STRENGTH OF ACTIVE INGREDIENT: Each ml contains: Travoprost USP 40 micrograms …..0.004% w/v Benzalkonium Chloride Ph. Eur ….. 0.015 % w/v (As preservative) Water for Injection Ph. Eur q.s to... 1 ml PRODUCT DESCRIPTION: Clear, colorless to pale yellow solution practically free from particles. PHARMACODYNAMICS: Travoprost, a prostaglandin F 2α PHARMACOKINETICS analogue, is a highly selective full agonist which has a high affinity for the prostaglandin FP receptor, and reduces the intraocular pressure by increasing the outflow of aqueous humour via trabecular meshwork and uveoscleral pathways. Reduction of the intraocular pressure in man starts about 2 hours after administration and maximum effect is reached after 12 hours. Significant lowering of intraocular pressure can be maintained for periods exceeding 24 hours with a single dose. _ABSORPTION: _ Travoprost is an ester prodrug. It is absorbed through the cornea where the isopropyl ester is hydrolyzed to the active free acid. Studies in rabbits have shown peak concentrations of 20 ng/mL of the free acid in aqueous humour one to two hours after topical dosing of Travoprost. Aqueous humour concentrations declined with a half-life of approximately 1.5 hours. _ _ _DISTRIBUTION: _ Following topical ocular administration of Travoprost to healthy volunteers, low systemic exposure to active free acid was demonstrated. Peak active free acid plasma concentrations of 25 pg/mL or less were observed between 10 and 30 minutes post-dose. Thereafter, plasma levels declined rapidly to below the 10 pg/mL assay quantitation limit before 1 hour post-administration. Due to the low plasma concentrations and rapid elimination following topical dosing, the elimination half-life of active free acid in man could not be determined. _ _ _BIOTRANSFORMATION: _ Metabolism is the major route of elimination of both Travoprost and the active free acid. The systemic metabolic pathways parallel those of endogenous p 전체 문서 읽기