Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
POVIDONE-IODINE
Seton Healthcare Group PLC
10%w/v %w/v
Cutaneous Solution
1993-06-02
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Brush-Off Cold Sore Treatment 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Povidone Iodine 10% w/v For excipients, see section 6.1 3 PHARMACEUTICAL FORM Cutaneous solution A clear, reddish brown, alcoholic/aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a topical antiseptic in the prevention and treatment of topical cutaneous infections. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION For topical administration. Use once or twice daily or as directed. Apply directly to the affected area and allow to dry. Cover with a dressing if desired. 4.3 CONTRAINDICATIONS 1. Use in patients with a known or suspected hypersensitivity to iodine. 2. Regular use in patients and users with thyroid disorders (in particular nodular colloid goitre, endemic goitre and Hashimoto’s thyroiditis). 3. Do not use on children under 2 years of age. 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE 1. If symptoms persist, consult your doctor. 2. Side effects include local irritation and hypersensitivity. 3. The product should not be used near the eyes. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION 1. Absorption of iodine from povidone iodine through either intact or damaged skin may interfere with thyroid function tests. 2. Contamination with povidone iodine of several types of tests for the detection of occult blood in faeces or blood in urine may produce false positive results. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Issued 24/10/2005_ _CRN 2016059_ _page number: 1_ 4.6 PREGNANCY AND LACTATION Regular use of povidone iodine should be avoided in pregnant or lactating women as absorbed iodine can cross the placental barrier and be secre Pročitajte cijeli dokument