Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
POVIDONE-IODINE
Medlock Medical Ltd
10 %w/v
Cutaneous Spray Solution
2005-02-11
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Betadine Mistette 10.0 % w/v 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Povidone iodine 10.0% w/v. Each ml contains 3 parts per million free iodine. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Cutaneous spray solution A reddish brown clear solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a topical antiseptic for the local management of minor skin trauma and the preparation of skin for surgical procedures. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For topical use only. Apply locally to affected area. 4.3 CONTRAINDICATIONS Use in patients with a known hypersensitivity to iodine. Use in children under 2 years of age. Use in patients with thyroid disorders. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Use of this preparation may interfere with tests of thyroid function. Special caution is needed when regular applications to broken skin are made in patients with pre-existing renal insufficiency. Regular use should be avoided in patients on concurrent lithium therapy. If used for prolonged periods, thyroid function tests should be performed. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. 4.6 PREGNANCY AND LACTATION Regular use should be avoided in pregnant or lactating women as absorbed iodine can cross the placental barrier and can be secreted in breast milk. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 20/07/2006_ _CRN 2025783_ _page number: 1_ 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Not applicable. 4.8 UNDESIRABLE EFFECTS Local skin reactions can occur. Application to large wounds or severe burns, can produce systemic adverse effects such as metabolic a Read the complete document