देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
Iodinated povidone
Mundipharma Pharmaceuticals Limited
D08AG; D08AG02
Iodinated povidone
100 milligram(s)/millilitre
Cutaneous solution
Iodine products; povidone-iodine
Not marketed
1983-04-01
1 PACKAGE LEAFLET: INFORMATION FOR THE USER BETADINE ALCOHOLIC 100 MG/ML CUTANEOUS SOLUTION Povidone Iodine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING BETADINE ALCOHOLIC 100 MG/ML CUTANEOUS SOLUTION. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects become serious, or if you notice any side effect not listed in this leaflet, stop using Betadine Alcoholic Solution straightaway and tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Betadine Alcoholic Solution is and what it is used for 2. 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. Further information 1. WHAT BETADINE ALCOHOLIC 100 MG/ML CUTANEOUS SOLUTION IS AND WHAT IT IS USED FOR Betadine Alcoholic Solution contains povidone iodine which kills a wide range of germs including bacteria, viruses, fungi and simple organisms. Betadine Alcoholic Solution is used as an antiseptic for pre-operative and post-operative treatment of skin. 2. BEFORE YOU USE BETADINE ALCOHOLIC 100 MG/ML CUTANEOUS SOLUTION DO NOT USE BETADINE ALCOHOLIC 100 MG/ML CUTANEOUS SOLUTION: - if you are allergic (hypersensitive) to povidone iodine or any of the other ingredients listed. - if you currently have or have ever had a thyroid problem, including swelling (nodular colloid goitre, endemic goitre or Hashimoto’s thyroiditis), as using Betadine Alcoholic Solution in these circumstances can further affect the function of your thyroid - if you are currently having lithium therapy for depression as this type of medicine can interact with Betadine Alcoholic Solution to affect the function of your thyroid - on children under two years of age. TALK TO YOUR DOCTOR OR PHARMACIST BEFORE USING BETADINE ALCOHOLIC 100 MG/ML CUTANEOUS SOLUTION पूरा दस्तावेज़ पढ़ें
Health Products Regulatory Authority 09 July 2019 CRN0091J5 Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Betadine Alcoholic 100 mg/ml Cutaneous Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of cutaneous solution contains 100 mg of Iodinated Povidone (10% w/v). This yields 10 mg/ml of available Iodine (1% w/v). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous solution A dark brown coloured solution with an odour of alcohol. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an antiseptic for pre- and post-operative treatment of skin. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For topical administration. Apply directly as required. 4.3 CONTRAINDICATIONS Hypersensitivity to iodine, polyvinylpyrrolidone or to any excipient. History of abnormal thyroid function or goitre (in particular nodular colloid goitre, endemic goitre and Hashimoto's thyroiditis). Use in children under two years of age. Regular use should be avoided in patients on concurrent lithium therapy. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Use of this preparation may interfere with tests of thyroid function. Iodine is absorbed through burns and broken skin and to a lesser extent through intact skin and may lead to toxic levels of iodine in the blood, particularly in patients with renal insufficiency. If symptoms occur suggesting changes in thyroid function, these should be investigated. In patients with impaired renal function, blood levels of iodine should be monitored. This preparation contains alcohol and is flammable. When used prior to a procedure which involves the use of an electrosurgical unit, do not allow pooling of the fluid to occur, and ensure that the skin and surrounding drapes are dry to reduce the risk of fires and burns. If local irritation and hypersensitivity develop, then discontinue treatment. Refer to section 4.8 for further information. Betadine Alcoholic Solution can permanently discolour white gold jewellery and it is recommended that this type पूरा दस्तावेज़ पढ़ें