Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
ciclosporin
Santen Oy
S01XA18
ciclosporin
Ophthalmologicals
Conjunctivitis; Keratitis
Treatment of severe vernal keratoconjunctivitis (VKC) in children from 4 years of age and adolescents.
Revision: 7
Authorised
2018-07-06
27 B. PACKAGE LEAFLET 28 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT VERKAZIA 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 Verkazia is and what it is used for 2. What you need to know before you use Verkazia 3. How to use Verkazia 4. Possible side effects 5. How to store Verkazia 6. Contents of the pack and other information 1. WHAT VERKAZIA IS AND WHAT IT IS USED FOR Verkazia contains the active ingredient, ciclosporin. Ciclosporin reduces the activity of the body’s immune (defence) system and in this way it reduces inflammation (body response to harmful stimuli). Verkazia is used to treat children and adolescents aged 4 to 18 years with severe vernal keratoconjunctivitis (an allergic condition of the eye that occurs more frequently in spring and affects the transparent layer in the front part of the eye and the thin membrane covering the front part of the eye). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE VERKAZIA DO NOT USE VERKAZIA - if you are allergic to ciclosporin or to 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 Verkazia in your eye as described under section 3. Do not exceed the treatment period prescribed by your doctor. Talk to your doctor or pharmacist before using Verkazia: - if you have had an eye infection or if you suspect you have an eye infection. - if you have any other kind of eye disease. Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Verkazia 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. 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 vernal keratoconjunctivitis (VKC) in children from 4 years of age and adolescents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Verkazia treatment should only be initiated by an ophthalmologist or a healthcare professional qualified in ophthalmology. Posology _Children from 4 years of age and adolescents _ The recommended dose is one drop of Verkazia 4 times a day (morning, noon, afternoon and evening) to be applied to each affected eye during the VKC season. If signs and symptoms of VKC persist after the end of the season, the treatment can be maintained at the recommended dose or decreased to one drop twice daily once adequate control of signs and symptoms is achieved. Treatment should be discontinued after signs and symptoms are resolved, and reinitiated upon their recurrence. _Missed dose _ If a dose is missed, treatment should be continued on the next instillation as normal. Patients should be advised not to instill more than one drop for each instillation in the affected eye(s). _Paediatric population _ There is no relevant use of Verkazia in children below 4 years in the treatment of severe vernal keratoconjunctivitis. _ _ _ _ 3 _Patients with renal or hepatic impairment _ The effect of Verkazia has not been studied in patients with renal or hepatic impairment. However, no special dose adjustment is needed in these populations. 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 contain Przeczytaj cały dokument