Država: Armenija
Jezik: engleski
Izvor: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
povidone-iodine
Arpimed LLC
D08AG02
povidone-iodine
10mg/ml
solution mouthwash
100ml and 120ml glass bottle
OTC
Registered
2018-10-30
SUMMARY OF PRODUCT CHARACTERISTICS BETAIODINE 1% MOUTHWASH SOLUTION POVIDONE IODINE 1.1 NAME OF THE MEDICAL PRODUCT – BETAIODINE 1.2 INTERNATIONAL NON-PROPERTY NAME – POVIDONE IODINE 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of Betaiodine, 1% mouthwash solution contains povidone iodine – 10 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Mouthwash solution. A dark brown colored liquid having a characteristic menthol odor. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This solution is used for the treatment of Acute Mucosal Infections of the mouth and pharynx e.g. gingivitis, mouth ulcers, for oral hygiene prior to, during, and after dental and oral surgery. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: Oral, as a gargle and mouthwash. The product should not be swallowed. Adults, the elderly and children over 6 years of age: Use undiluted with an equal volume of warm water. Gargle or rinse with up to 10mls for up to 30 seconds without swallowing. Repeat up to four times daily, for up to 14 consecutive days, or as directed. Not to be used in children of 6 years and under. 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). Regular use should be avoided in patients on concurrent lithium therapy. Do not use in children of 6 years and under. 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. Do not use for more than 14 days. If local irritation and hyper Pročitajte cijeli dokument