Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
POVIDONE-IODINE
Seton Healthcare Group PLC
POVIDONE-IODINE
5 %w/v
Ear Drops Solution
Withdrawn
2006-05-23
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Betadine Ear Drops. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Povidone Iodine 5 % w/v For excipients, see section 6.1 3 PHARMACEUTICAL FORM Ear drops, solution. Iodine-coloured, clear, aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an antiseptic for the management of superficial ear infections. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION For topical administration. Three to four drops instilled by dropper four times daily, or as directed by the physician. 4.3 CONTRAINDICATIONS 1. Use in patients who are iodine-sensitive. 2. Use in patients with perforated ear drum. 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE Care must be taken when applying the product to areas of broken skin, as excessive absorption of iodine may occur. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None stated. 4.6 PREGNANCY AND LACTATION Use in pregnancy and lactation should be limited and although no adverse effects are anticipated when used at the recommended dose, caution is recommended and therapeutic benefit must be balanced against possible effects of the absorption of iodine on foetal thyroid function and development. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Issued 24/10/2005_ _CRN 2016054_ _page number: 1_ 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None stated. 4.8 UNDESIRABLE EFFECTS Povidone iodine may produce local skin reactions although it is considered to be less irritant than iodine. 4.9 OVERDOSE In the case of accidental ingestion of large quantities of Betadine, symptomatic and supportive treatment should be provided with special attention to electrolyte balance and renal and thyroid function. 5 PHARMACOLOGICAL PROPERT Pročitajte cijeli dokument