País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
IODINATED POVIDONE PH.EUR. ISOPROPANOL
B. Braun Medical Limited
IODINATED POVIDONE PH.EUR. ISOPROPANOL
500/10 mg/g
Cutaneous Solution
Product not subject to medical prescription
Withdrawn
0000-00-00
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Braunoderm Non-Coloured, Isopropyl Alcohol 500mg/g and Iodinated Povidone 10mg/g Cutaneous Solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION _Active ingredients:_ 100 g solution contains: 50.0 g Isopropyl Alcohol Ph. Eur. 1.0 g Iodinated Povidone Ph. Eur., with a content of 10% available iodine. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Cutaneous solution. Clear, brown 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 undiluted Braunoderm non-coloured to the skin area to be disinfected and spread with sterile swab. Wet the skin to be treated completely and then let dry. 4.3 CONTRAINDICATIONS Use in patients with hypersensitivity to iodine or the other excipients. Before and after radio-iodine-therapy (until complete healing). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE None stated. 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, as well as patients suffering from non-infected nodular strumae or latent hyperthyreosis. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 06/03/2008_ _CRN 2047046_ _page number: 1_ 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None stated. 4.8 UNDESIRABLE EFFECTS Allergic reactions. 4.9 OVERDOSE Because the preparation is only applied locally, no overdose can result. 5 PHARMACOLOGICAL PROPERTIES 5.1 PHARMACODYNAMIC PROPERTIES Alcoholic soluti Llegiu el document complet