Држава: Малта
Језик: Енглески
Извор: Medicines Authority
POVIDONE, IODINE
Mundipharma Pharmaceuticals Limited 13 Othellos Street, Dhali Industrial Zone, Nicosia, Cyprus
D08AG02
POVIDONE-IODINE 10 % (W/V)
CUTANEOUS SOLUTION
POVIDONE-IODINE 10 % (W/V)
OTC
ANTISEPTICS AND DISINFECTANTS
Authorised
2006-05-26
PILBALCMT01v2.01 PACKAGE LEAFLET: INFORMATION FOR THE USER BETADINE ® ALCOHOLIC SOLUTION 10% W/V Povidone-Iodine 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, pharmacist, or nurse. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What BETADINE ® ALCOHOLIC SOLUTION is and what it is used for 2. What you need to know before you use BETADINE ® ALCOHOLIC SOLUTION 3. How to use BETADINE ® ALCOHOLIC SOLUTION 4. Possible side effects 5. How to store BETADINE ® ALCOHOLIC SOLUTION 6. Contents of the pack and other information 1. WHAT BETADINE ® ALCOHOLIC SOLUTION IS AND WHAT IT IS USED FOR _ _ BETADINE ® ALCOHOLIC SOLUTION is an antiseptic indicated for degerming skin, and wounds in: - Pre-operative preparation of skin. - Post-operative surgical wound infection. - Casualty procedures, including prevention of infection in lacerations and abrasions. BETADINE ® ALCOHOLIC SOLUTION is an antiseptic skin cleanser for wounds where a quick drying effect is desired. It is used also for the treatment of various bacterial, viral, protozoal and mycotic skin infections. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BETADINE ® ALCOHOLIC SOLUTION _ _ DO NOT USE BETADINE ® ALCOHOLIC SOLUTION_ _ - If you are allergic to Povidone-Iodine or any of the other excipients of this medicine (listed in section 6). - in patients hypersensitive to the active substance(s) or to any of the excipients listed in section 6. - in patients with thyroid disorders (in particular nodular colloid goiter, endemic goiter and Hashimoto's thyroiditis). - in patients taking lithium. - in children under 1 year of age. - before during and after radio-iodine administration. - in patients using products containing mercury WARNINGS AND PRECAUTIONS_ _ Talk Прочитајте комплетан документ
Page 1 of 7 SPCBALCMT01v2.01 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT BETADINE ® ALCOHOLIC SOLUTION 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Povidone-Iodine Ph. Eur. 10.00% w/v For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Hydro alcoholic solution For topical administration. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BETADINE ® ALCOHOLIC SOLUTION is indicated for degerming skin, and wounds in hospital and office procedures. • Pre-operative preparation of skin. • Post-operative surgical wound infection. • Casualty procedures, including prevention of infection in lacerations and abrasions. BETADINE ® ALCOHOLIC SOLUTION is an antiseptic cleanser for skin and wounds where a quick drying effect is desired. It is used also for the treatment of various bacterial, viral, protozoal and mycotic skin infections. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Paediatric population _ BETADINE ® ALCOHOLIC SOLUTION is contraindicated in children below the age of 1 year (see section 4.3). Method of administration For topical use only. Spread the solution, undiluted, onto the areas to be treated. The solution can be applied twice daily. Cover with dressing if desired. A. For disinfection of the hands the procedure is as follows: a) Hygienic disinfection of the hands: 3ml undiluted – allow drying. b) Surgical disinfection 2x5ml undiluted – allow drying. B. For disinfection of the skin the procedure is as follows: Before injections, punctures and surgical operations, allow the solution to dry. Page 2 of 7 SPCBALCMT01v2.01 4.3 CONTRAINDICATIONS Contraindicated in: • Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. • Hyperfunction of the thyroid (hyperthyroidism), other manifest thyroid diseases esp. nodular colloidal goitre, endemic goitre, Hashimoto’s thyroiditis, as well as before and after radioiodine therapy for hyperthyroidism, until a lasting cure has been obtained. • Before, during and afte Прочитајте комплетан документ