Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
Iodinated povidone
Bausch Health Ireland Limited
S01AX; S01AX18
Iodinated povidone
5 percent weight/volume
Eye drops, solution
Other antiinfectives; povidone-iodine
Marketed
2012-12-14
PACKAGE LEAFLET: INFORMATION FOR THE USER MINIMS® POVIDONE 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 drops solution. It is used for cleaning the surface of your eye before eye surgery or eye injection. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE MINIMS POVIDONE IODINE DO NOT USE MINIMS POVIDONE IODINE - If you are allergic to povidone iodine, or any product containing povidone iodine or _ _ any of the other ingredients of the medicine listed in section 6. - In pre-term infants. - For injecting into the eye and the eye surroundings. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Minims Povidone Iodine: - If you have a thyroid disorder. Monitoring of thyroid function is should be considered, particularly in the elderly, during regular repeated use of this medicine. - If you have dry eyes syndrome. Special warnings Minims Povidone Iodine 5% w/v eye drops, solution is strictly only for use to clean the eyes before surgery or eye injection and should not be used for any other purpose. Precautions for use After Leggi il documento completo
Health Products Regulatory Authority 13 September 2019 CRN008P87 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 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 0.75 mg/ml (0.03 mg in each drop) ( 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 and/or intravitreal injection to support post-procedural infection control. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults (including the elderly)_ Instill 2 to 3 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 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 single-dose 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 This medicinal product must not be used in the following situations: - Hypersensitivity to iodinated povidone, to iodine or to any of the excipients listed in s Leggi il documento completo