Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Iodinated povidone
Bausch & Lomb UK Limited
S01AX; S01AX18
Iodinated povidone
5 percent weight/volume
Eye drops, solution
Product subject to prescription which may not be renewed (A)
Other antiinfectives; povidone-iodine
Marketed
2012-12-14
Graphics&Packing Technology Section ICN POLFA RZESZÓW S.A. ULOTKA PIL Nazwa produktu Product Name MINIMS POVIDONE IODINE 5% W/V DRP SOL 20 SINGLE DOSE UNITS Kolor nadruku Colours Black Kraj Country (ISO) UNITED KINGDOM (UK), IRELAND (IE) Nr wykrojnika Spec No 5338 Opracowane przez Designed by Kod Wytwórcy Manufacturer code 76920 Nr korekty Proof No 5 Data Date 19.05.2016 Kod farmaceutyczny Pharmacode - Kod wersji Valeant version code P1UKIE01 Inny kod Other code - Rozmiar czcionki Font size MINIMUM 8 PT Wymiar ulotki PIL size 160 X 240 MM Krój czcionki Font used Nobel BL Font family Gramatura papieru Paper weight 60 G/M 2 Komentarze Comments (Reason for the change) NATIONAL REGISTRATION OF TEXT FOLLLOWING - SAFETY VARIATION AND QRD UPDATE PMR_ICN-15-1289-A PACKING SITE: LABORATOIRE CHAUVIN, AUBENAS, FRANCE Akceptacja Techniczna Technical Approval Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval MINIMS ® POVIDONE IODINE 5% W/V EYE DROPS, SOLUTION Iodinated Povidone 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 your 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 Minims Povidone Iodine is and what it is used for 2. What you need to know before you use Minims Povidone Iodine 3. How to use Minims Povidone Iodine 4. Possible side effects 5. How to store Minims Povidone Iodine 6. Contents of the pack and other information 1. WHAT MINIMS POVIDONE IODINE IS AND WHAT IT IS USED FOR Minims Povidone Iodine is a solution that contains an antiseptic known as Iodinated Povidone in an eye wash solution. It is used for cleani Прочетете целия документ
HealthProductsRegulatoryAuthority 27February2019 CRN008L5X Page1of5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT MinimsPovidoneIodine5%w/vEyeDrops,Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Eachsingledosecontainerprovides20mgofIodinatedPovidonein0.4mlofsolution.Onemlofsolutioncontains50mg IodinatedPovidone Excipientwithknowneffect:disodiumphosphateanhydrous(seesection4.8). Forafulllistofexcipients,seesection6.1. 3 PHARMACEUTICAL FORM EyeDrops,Solution Deepbrown-redcolouredsolution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS MinimsPovidoneIodine5%w/vEyeDrops,Solutionisindicatedforcutaneousperi-ocularandconjunctivalantisepsispriorto ocularsurgerytosupportpost-operativeinfectioncontrol. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults (including the elderly): _ Instiltwotothreedropsofthesolutionontotheeye/eyesandleavefortwominutes. See“MethodofAdministration”forfurtherdetails. _Paediatric population: _ Theadultdosemaybeusedinneonates,infants,childrenandadolescents _Method of administration_: -Washhandsthoroughlybeforeuse. -Cleantheareaaroundtheeyeswithasterilecottonswab -Twistoffthecapofthecontainertoopenit -Donottouchtheeyewiththesingle-dosecontainernozzle. -Gentlyinstil2to3dropsofthesolutionontotheeye/eyes -Allowthesolutiontospread,byaskingthepatienttoclosetheireyesandrolltheireyesaround -Leavethedropsontheeye/eyesfortwominutesbeforerinsing:Usinga Прочетете целия документ