Nchi: Uingereza
Lugha: Kiingereza
Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)
Povidone-Iodine
Bausch & Lomb UK Ltd
S01AX18
Povidone-Iodine
50mg/1ml
Eye drops
Ocular
No Controlled Drug Status
Valid as a prescribable product
BNF: 11080200; GTIN: 5027519008858
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 Soma hati kamili
OBJECT 1 MINIMS POVIDONE IODINE 5% W/V EYE DROPS, SOLUTION Summary of Product Characteristics Updated 14-Nov-2017 | Bausch & Lomb U.K Limited 1. Name of the medicinal product Minims® Povidone Iodine 5% w/v eye drops, solution 2. Qualitative and quantitative composition Each single dose container provides 20 mg of Iodinated Povidone in 0.4 ml of solution. One milliliter of solution contains 50 mg Iodinated Povidone Excipient with known effect: disodium phosphate anhydrous ( see section 4.8). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Eye drops, solution Deep brown-red coloured solution. 4. Clinical particulars 4.1 Therapeutic indications Minims® Povidone Iodine 5% w/v eye drops, solution is indicated for cutaneous peri-ocular and conjunctival antisepsis prior to ocular surgery to support post-operative infection control. 4.2 Posology and method of administration Posology _Adults (including the elderly)_ Instill two to three drops of the solution onto the eye / eyes and leave for two minutes. See “Method of Administration” for further details. _Paediatric population_ The adult dose may be used in neonates, infants, children and adolescents Method of administration: - Wash hands thoroughly before use. - Clean the area around the eyes with a sterile cotton swab - Twist off the cap of the container to open it - Do not touch the eye with the single-dose container nozzle. - Gently instill 2 to 3 drops of the solution onto the eye / eyes - Allow the solution to spread, by asking the patient to close their eyes and roll their eyes around - Leave the drops on the eye / eyes for two minutes before rinsing: Using a suitable syringe, irrigate the eye / eyes thoroughly with sterile saline 0.9% w/v solution until the characteristic colour of the iodine solution disappears 4.3 Contraindications - Hypersensitivity to iodinated povidone, to iodine or to any of the excipients listed in section 6.1 - Minims® Povidone Iodine 5% w/v eye drops, solution is contraindicated for intra-ocular or peri-oc Soma hati kamili