מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
POVIDONE-IODINE
B. Braun Medical Limited
10 %w/w
Ointment
1986-06-05
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Braunovidon 100 mg/g Ointment 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Ingredient 100g ointment contain: 10g Iodinated Povidone with a content of 10 % available iodine. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Ointment Light to medium brown ointment. 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 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, as well as patients suffering from noninfected nodular strumae or latent hyperthyreosis. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 10/01/2007_ _CRN 2031793_ _page number: 1_ 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Not relevant. 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 קרא את המסמך השלם