Land: Armenia
Språk: engelsk
Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
povidone-iodine
Arpimed LLC
povidone-iodine
100mg/ml
solution for external use
OTC
SUMMARY OF PRODUCT CHARACTERISTICS BETAIODINE 10% SOLUTION FOR EXTERNAL USE 1.1 NAME OF THE MEDICAL PRODUCT – Betaiodine 1.2 INTERNATIONAL NON-PROPERTY NAME – Povidone - iodine 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of the solution contains povidone-iodine 100 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for external use. A brown colored liquid having a characteristic iodine odor. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For use as a pre-operative and post-operative antiseptic skin cleanser for major and minor surgical procedures. As a general antiseptic solution in the prevention and treatment of infections. For the treatment of cold sores. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Topical administration. Adults, the elderly and children over 2 years of age: Apply full strength as a pre-operative and post-operative antiseptic skin cleanser. For use as a pre-operative and post-operative antiseptic skin cleanser for major and minor surgical procedures: Avoid pooling both under the patients and in the skin folds. Wash off excess solution before using occlusive dressings. As a general antiseptic solution in the prevention and treatment of infections: apply Povidone- iodine solution undiluted as necessary to the affected area and allow to dry. Rinse the brush thoroughly after use. For the treatment of cold sores: apply twice daily to the affected area and allow to dry. Not to be used on children under 2 years of age. 4.3 CONTRAINDICATIONS Hypersensitivity to iodine, polyvinylpyrrolidine 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 Les hele dokumentet