Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
POVIDONE-IODINE
Medlock Medical Ltd
Cutaneous Stick
2005-02-11
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Betadine Swabsticks 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of impregnating solution contains 10% w/v povidone iodine, which contains 3 parts per million free iodine. Each 3 swab packet will contain 7.0g of solution. Each 5 swab packet will contain 14.0g of solution. Each single swab packet contains 2.33g of impregnating solution. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Swabsticks impregnated with a cutaneous solution. Swabsticks impregnated with an aqueous iodine coloured solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an antiseptic for cleansing and preparation procedures. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For topical use only. Swab area thoroughly. Use swab only. Use as required. 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 2025790_ _page number: 1_ 4.7 E Read the complete document