Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
DEXAMETHASONE PHOSPHATE
Wockhardt UK Limited
S01BA; S01BA01
DEXAMETHASONE PHOSPHATE
1 milligram(s)/millilitre
Eye drops, solution in single-dose container
Product subject to prescription which may not be renewed (A)
Corticosteroids, plain; dexamethasone
Not marketed
2014-12-12
PACKAGE LEAFLET: INFORMATION FOR THE USER DEXAMETHASONE PHOSPHATE 1MG/ML (AS SODIUM PHOSPHATE) EYE DROPS, SOLUTION IN A SINGLE-DOSE CONTAINER 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. The name of your medicine is Dexamethasone Phosphate 1mg/ml (as sodium phosphate) Eye Drops, Solution in a single-dose container. Throughout the rest of this leaflet it is referred to as Dexamethasone Phosphate Eye Drops. WHAT IS IN THIS LEAFLET: 1. What Dexamethasone Phosphate Eye Drops are and what it is used for 2. What you need to know before you use Dexamethasone Phosphate Eye Drops 3. How to use Dexamethasone Phosphate Eye Drops 4. Possible side effects 5. How to store Dexamethasone Phosphate Eye Drops 6. Contents of the pack and other information 1. WHAT DEXAMETHASONE PHOSPHATE EYE DROPS ARE AND WHAT IT IS USED FOR Dexamethasone Phosphate Eye Drops contains dexamethasone, which is a corticosteroid used to stop inflammatory symptoms (such as pain, heat swelling and redness). Dexamethasone Phosphate Eye Drops is used to treat inflammation of your eyes. If you have an infected eye (red eye, tears and mucous), you will be given another medicine to take at the same time as Dexamethasone Phosphate Eye Drops. See Section 2. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE DEXAMETHASONE PHOSPHATE EYE DROPS DO NOT USE DEXAMETHASONE PHOSPHATE EYE DROPS • if you are suffering from an eye infection that you are not using a medicine for • if you have damage to the surface of the eye (including ulcers or injuries which have not healed properly), Прочитайте повний документ
Health Products Regulatory Authority 22 January 2019 CRN008RV8 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dexamethasone Phosphate 1mg/ml (as sodium phosphate) Eye Drops Solution in a single dose container 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Dexamethasone sodium phosphate equivalent to 0.1% w/v dexamethasone phosphate Each ml of solution contains 1mg of dexamethasone phosphate (as dexamethasone sodium phosphate). Each individual single-dose unit contains 0.4mg 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 in a single container. Single use eye drops which are sterile and preservative free. A colourless solution when examined under suitable conditions of visibility, which is clear and free from particles. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of non-infectious inflammatory conditions affecting the anterior segment of the eye. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dexamethasone phosphate 1mg/ml (a sodium phosphate) Eye Drops, solution in a single-dose container is for ocular use only. This product should be used under close ophthalmic supervision. Posology The usual dose is 1 drop, 4 to 6 times daily in the affected eye. Health Products Regulatory Authority 22 January 2019 CRN008RV8 Page 2 of 9 In severe cases, treatment may be started with 1 drop every hour but dosage should be reduced to 1 drop every 4 hours when a 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 recommendation 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-t Прочитайте повний документ