Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
ciclosporin
Santen Oy
S01XA18
ciclosporin
Ophthalmologicals
Corneal Diseases
Treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes.
Revision: 10
Authorised
2015-03-19
32 B. PACKAGE LEAFLET 33 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT IKERVIS 1 MG/ML, EYE DROPS, EMULSION ciclosporin 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 IKERVIS is and what it is used for 2. What you need to know before you use IKERVIS 3. How to use IKERVIS 4. Possible side effects 5. How to store IKERVIS 6. Contents of the pack and other information 1. WHAT IKERVIS IS AND WHAT IT IS USED FOR IKERVIS contains the active substance, ciclosporin. Ciclosporin belongs to a group of medicines known as immunosuppressive agents that are used to reduce inflammation. IKERVIS is used to treat adults with severe keratitis (inflammation of the cornea, the transparent layer in the front part of the eye). It is used in those patients who have dry eye disease, which has not improved despite treatment with tear substitutes (artificial tears). Talk to a doctor if you do not feel better or if you feel worse. You should visit your doctor at least every 6 months to assess the effect of IKERVIS. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE IKERVIS _ _ DO NOT USE IKERVIS - if you are allergic to ciclosporin or any of the other ingredients of this medicine (listed in section 6). - if you have had or have a cancer in or around your eye. - if you have an eye infection. WARNINGS AND PRECAUTIONS Only use IKERVIS for dropping in your eye(s). Talk to your doctor or pharmacist before using IKERVIS - if you have previously had an eye infection by the herpes virus that might have damaged the transparent front part of th Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT IKERVIS 1 mg/mL eye drops, emulsion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One mL of emulsion contains 1 mg of ciclosporin. Excipient with known effect: One mL of emulsion contains 0.05 mg cetalkonium chloride (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, emulsion. Milky white emulsion. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATION Treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment must be initiated by an ophthalmologist or a healthcare professional qualified in ophthalmology. Posology The recommended dose is one drop once daily to be applied to the affected eye(s) at bedtime. Response to treatment should be reassessed at least every 6 months. If a dose is missed, treatment should be continued on the next day as normal. Patients should be advised not to instil more than one drop in the affected eye(s). Special populations _Elderly patients _ The elderly population has been studied in clinical studies. No dose adjustment is required. _ _ _Patients with renal or hepatic impairment _ The effect of ciclosporin has not been studied in patients with hepatic or renal impairment. However, no special considerations are needed in these populations. 3 _Paediatric population _ There is no relevant use of ciclosporin in children and adolescents aged below 18 in the treatment of severe keratitis in patients with dry eye disease, which has not improved despite treatment with tear substitutes. Method of administration Ocular use. _Precautions to be taken before administering the medicinal product _ Patients should be instructed to first wash their hands. Prior to administration, the single-dose container should be gently shaken. For single use only. Each single-dose container is sufficient to treat both eyes. Any unused emulsion shoul Прочетете целия документ