Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
POVIDONE-IODINE ISOPROPANOL
B. Braun Medical Limited
1 %w/v
Cutaneous Solution
1986-06-05
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Braunoderm Coloured Isopropyl Alcohol 500 mg/g and Iodinated Povidone 10 mg/g Cutaneous Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Ingredients: 100.0 g solution contains: 50.0 g Isopropyl Alcohol 1.0 g Iodinated Povidone, with a content of 10 % available iodine Excipients: Sunset Yellow (E110) 0.075% w/w Ponceau 4R (E124) 0.05% w/w Brilliant Black BN (E151) 0.0015% w/w For 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 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 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. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 10/01/2007_ _CRN 2031802_ _page number: 1_ 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 noninfected nodular strumae or latent hyperthyreosis. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE Đọc toàn bộ tài liệu