Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Iodinated povidone
Ayrton Saunders Ltd
D08AG; D08AG02
Iodinated povidone
100 milligram(s)/millilitre
Cutaneous solution
Product subject to prescription which may be renewed (B)
Iodine products; povidone-iodine
Not marketed
1983-04-01
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 of jewellery should be removed before using Betadine Alcoholic Solution Læs hele dokumentet