Country: মাল্টা
ভাষা: ইংরেজি
সূত্র: Medicines Authority
DEXAMETHASONE PHOSPHATE
Rayner Pharmaceuticals Ltd 10 Dominion Way, Worthing, West Sussex, BN14 8AQ,, United Kingdom
S01BA01
DEXAMETHASONE PHOSPHATE 1 mg/ml
EYE DROPS, SOLUTION
DEXAMETHASONE PHOSPHATE 1 mg/ml
POM
OPHTHALMOLOGICALS
Withdrawn
2013-01-28
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER DROPODEX 0.1% W/V EYE DROPS, SOLUTION 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 Dropodex Eye Drops are and what they are used for 2. What you need to know before you use Dropodex 3. How to use Dropodex 4. Possible side effects 5. How to store Dropodex 6. Contents of the pack and other information 1. WHAT DROPODEX EYE DROPS ARE AND WHAT THEY ARE USED FOR Each Dropodex single-dose container contains the active ingredient dexamethasone phosphate (as dexamethasone sodium phosphate), at a concentration of 0.1% w/v (1 mg/ml). Each Dropodex sterile single-dose container holds approximately 0.4 ml of solution. Dropodex belongs to the group of corticosteroids that suppresses inflammation. Dropodex is used for: - Certain cases of inflammation in the front of the eye such as the inflammation of the cornea, conjunctiva and iris and connective tissue. - Hypersensitive reaction of the conjunctiva not responding to standard treatments. - Treatment of inflammation of the eye, as long as the eye is not infected. Your doctor may sometimes use other drugs at the same time as Dropodex to make sure that your eye is treated effectively. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE DROPODEX EYE DROPS DO NOT USE DROPODEX EYE DROPS: - If you are allergic to dexamethasone sodium phosphate or any of the other ingredients of this medicine (listed in section 6). - In case of bacterial eye infections ( সম্পূর্ণ নথি পড়ুন
Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Dropodex 0.1% w/v Eye Drops, solution. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Dexamethasone sodium phosphate Ph Eur equivalent to 0.1% w/v dexamethasone. Each ml of solution contains 1 mg 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 eye drops which are sterile and preservative free. A colourless solution when examined under suitable conditions of visibility, clear and free from particles. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dropodex 0.1% w/v Eye Drops are indicated for inflammatory conditions of the anterior segment of the eye, such as marginal keratitis, stromal oedema in keratitis, anterior uveitis, episcleritis (if NSAIDs are contraindicated or insufficient), scleritis, acute phase of severe allergic conjunctivitis not responding to standard therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults (including the elderly) _ The usual dose in adults, including the elderly, is 1 drop, 4 to 6 times daily. In severe conditions, the treatment can be used more frequently at first (1 drop every hour), and then reduced to 1 drop every 4 hours as the eye inflammation subsides. Dexamethasone sodium phosphate dosage should be progressively reduced. _Paediatric population _ Use of Dropodex 0.1% w/v Eye Drops, solution in children and adolescents must be restricted. Page 2 of 7 No data on safety and efficacy are available for children aged less than 2 years. Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made. In children, long-term continuous corticosteroid therapy should be avoided due to possible adrenal suppression (see section 4.4). Method of administration Ocular use. 4.3 CONTRAINDICATIONS Hypersen সম্পূর্ণ নথি পড়ুন