Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
IODINATED POVIDONE PH.EUR.
Ayrton Saunders Ltd
D08AG; D08AG02
IODINATED POVIDONE PH.EUR.
10 percent weight/weight
Ointment
Product not subject to medical prescription
Iodine products; povidone-iodine
Not marketed
1983-04-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Betadine 10% w/w Ointment 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Iodinated Povidone 10% w/w (yielding 1% w/w available iodine) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Ointment Smooth, uniform, dark brown ointment. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a topical antiseptic for management of minor trauma or infection of the skin. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Apply to the affected area, once or twice daily for a maximum of 14 days. 4.3 CONTRAINDICATIONS Hypersensitivity to iodine, polyvinylpyrrolidone or to any excipient. History of abnormal thyroid function or goitre (in particular nodular colloid goitre, endemic goitre and Hashimoto’s thyroiditis). Use in children under two years of age. Regular use should be avoided in patients on concurrent lithium therapy. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Use of this preparation may interfere with tests of thyroid function. Iodine is absorbed through burns and broken skin and to a lesser extent through intact skin and may lead to toxic levels of iodine in the blood, particularly in patients with renal insufficiency. If symptoms occur, suggesting changes in thyroid function, these should be investigated. In patients with impaired renal function, blood levels of iodine should be monitored. If local irritation and hypersensitivity develop, then discontinue treatment. Refer to section 4.8, “Undesirable effects” for further information. Betadine Ointment can permanently discolour white gold jewellery and it is recommended that this type of jewellery should be removed before using Betadine Ointment. I R I S H M E D I C I N E S B O A R D ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Lestu allt skjalið