Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
POVIDONE-IODINE
B. Braun Medical Limited
POVIDONE-IODINE
7.5 %w/v
Cutaneous Solution
Product not subject to medical prescription
Withdrawn
0000-00-00
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Braunol 75 mg/g Cutaneous Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Ingredient 100 g solution contain: 7.5 g Iodinated Povidone, with a content of 10 % available iodine. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous solution Clear, brown, aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a topical antiseptic for disinfection of intact skin. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Apply to the affected area. 4.3 CONTRAINDICATIONS Hypersensitivity to iodine or any of the other excipients. Use before radio-iodine therapy. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Should evidence of local irritation or sensitivity occur, use of the product should cease. If no improvement occurs, the doctor should be consulted. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Iodine reacts with mercury compounds forming strongly caustic mercurous iodide. 4.6 PREGNANCY AND LACTATION Care must be taken in the case of pregnant women and infants up to the age of 6 months. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Not applicable. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 10/01/2007_ _CRN 2031833_ _page number: 1_ 4.8 UNDESIRABLE EFFECTS Allergic reactions are very rare, even in iodine sensitive patients. 4.9 OVERDOSE Because the preparation is only applied locally, no overdose can result. 5 PHARMACOLOGICAL PROPERTIES 5.1 PHARMACODYNAMIC PROPERTIES Pharmacotherapeutic group: Antiseptics and Disinfectants – Iodine products, ATC code: D08 AG02. Iodinated povidone (povidone iodine) is an iodophor used for disinfection and antisepsis. Iodophors ar read_full_document