מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
Dexamethasone sodium phosphate
Alissa Healthcare Research Limited
S01BA; S01BA01
Dexamethasone sodium phosphate
1.0 milligram(s)/millilitre
Eye drops, solution
Eye solution use
Pack size: 20 single dose containers
Product subject to prescription which may not be renewed (A)
Farma Mediterrània S.L, Novocat Farma S.A.
Corticosteroids, plain
Corticosteroids, plain; dexamethasone
For treatment of non-infectious inflammatory conditions affecting the anterior segment of the eye
Not marketed
2015-03-13
Alissa Healthcare Research Limited UK/H/5450/01/IB/006 Variation to updated in line with PRAC 1 PACKAGE LEAFLET: INFORMATION FOR THE USER DEXAMETHASONE PHOSPHATE 1 MG/ML EYE DROPS, SOLUTION, PRESERVATIVE FREE Dexamethasone phosphate (as dexamethasone sodium phosphate) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Dexamethasone eye drops is and what it is used for 2. What you need to know before you use Dexamethasone eye drops 3. How to use Dexamethasone eye drops 4. Possible side effects 5. How to store Dexamethasone eye drops 6. Contents of the pack and other information The full name of your medicine is Dexamethasone phosphate 1 mg/ml eye drops, solution, preservative free which is presented in single-dose containers. In this leaflet the shorter name Dexamethasone eye drops is used. 1. WHAT DEXAMETHASONE EYE DROPS IS AND WHAT IT IS USED FOR Dexamethasone eye drops contains dexamethasone, which is a corticosteroid used to treat inflammatory symptoms (such as pain, swelling and redness). Dexamethasone eye drops is used to treat inflammatory conditions affecting the front part of the eye that are not caused by infections. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE DEXAMETHASONE EYE DROPS DO NOT USE DEXAMETHASONE EYE DROPS: if you are allergic to dexamethasone sodium phosphate or any of the other ingredients of this medicine (listed in section 6) if you are suffering from an eye infection that is untreated if you have damage to the surface of the eye (including, ulcers or injuries קרא את המסמך השלם
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dexamethasone phosphate 1 mg/ml eye drops, solution, preservative free 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution contains 1 mg of dexamethasone phosphate as dexamethasone sodium phosphate. Each individual single-dose unit contains 0.4 mg dexamethasone phosphate (as dexamethasone sodium phosphate) in 0.4 ml of solution. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution. Single-use, unpreserved sterile eye drops. A colourless solution when examined under suitable conditions of visibility, practically clear and practically free from particles. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For treatment of non-infectious inflammatory conditions affecting the anterior segment of the eye. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dexamethasone phosphate 1 mg/ml eye drops, solution, preservative free is for ocular use only. This product should be used only under close ophthalmic supervision. _Posology_ The usual posology is of 1 drop 4 to 6 times daily in the affected eye. In severe cases, treatment may be started with 1 drop every hour but dosage should be reduced to one drop every 4 hours when favourable response is observed. Gradual tapering off is recommended in order to avoid a relapse. The duration of treatment will generally vary from a few days to a maximum of 14 days. _Elderly patients_ There has been wide experience with the use of dexamethasone eye drops in elderly patients. The dosage recommendations given above reflect the clinical data derived from this experience. _Paediatric population_ Efficacy and safety has not been established in the paediatric population. In children, long-term continuous corticosteroid therapy should be avoided due to possible adrenal suppression (see section 4.4). METHOD OF ADMINISTRATION Dexamethasone is a sterile solution that does not contain a preservative. The solution from one individual single dose H E A L T H P R O D U C T S R E G U L A T O R Y A קרא את המסמך השלם