Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
POVIDONE-IODINE
Medlock Medical Ltd
POVIDONE-IODINE
10 %w/v
Impregnated Dressing
Withdrawn
2006-10-06
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Betadine Antiseptic Swab 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each cotton swab contains 1g of solution, each ml of the solution contains 10% w/v povidone iodine, which contains 3 parts per million of free iodine. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Swab impregnated with a cutaneous solution. Sachet containing a folded 100% surgical grade cotton swab impregnated with a clear golden brown iodinated solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an antiseptic for cleansing and preparation of sites. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For topical use only. Swab area thoroughly. Use swab once 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 preformed. 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 2025767_ _page number: 1_ 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Not applicable. 4.8 UNDESIRA Leggi il documento completo