Land: Ierland
Taal: Engels
Bron: 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
Health Products Regulatory Authority 09 July 2019 CRN0091J5 Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Standardised Betadine Antiseptic 100 mg/ml Cutaneous Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of cutaneous solution contains 100 mg Iodinated Povidone (10% w/v) yielding 10 mg/ml (1% w/v) of available iodine. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous solution A dark brown coloured cutaneous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a topical antiseptic for the local management of minor skin trauma, and in the preparation of skin for surgical procedures. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For topical administration. Apply locally to affected area. 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. If local irritation and hypersensitivity develop, then discontinue treatment. Refer to section 4.8 for further information. Standardised Betadine Antiseptic Solution can permanently discolour white gold jewellery and it is recommended that this type of jewellery should be removed before using Standardised Betadine Antiseptic Solution. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTIONS Use with concurrent lithium therap Lees het volledige document