Country: Հայաստան
language: անգլերեն
source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
potassium iodide
Merck KGaA Frankfurter Strasse 250
potassium iodide
100mcg
tablets
OTC
Translation: July 2012 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINALPRODUCT Jodbalance 100 microgram tablets Jodbalance 200 microgram tablets 2. QUALITATIVEANDQUANTITATIVECOMPOSITION Jodbalance 100 microgram: Each tablet contains 100 microgram iodide as 130.8 microgram potassium iodide. Jodbalance 200 microgram: Each tablet contains 200 microgram iodide as 261.6 microgram potassium iodide. Excipients: Contains 84 mg lactose monohydrate For a full list of excipients, see section 6.1. 3. PHARMACEUTICALFORM Tablet. Jodbalance 100 microgram tablets White, circular tablets with dividing score, being embossed: EM 33 The tablet can be divided into equal halves. Jodbalance 200 microgram tablets White, circular tablets with dividing score, being embossed: EM 70 The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. CLINICALPARTICULARS 4.1 THERAPEUTICINDICATIONS Goitre prevention in the presence of iodide deficiency, particularly in pregnancy andlactation Prevention of recurrent goitre growth after completion of thyroid hormone treatment or after surgery on goitre due to iodidedeficiency Goitre due to iodide deficiency in new-born infants, children, andadolescents 4.2 POSOLOGY AND METHOD OFADMINISTRATION Consideration must be given to regional and individual variations in nutritional iodide supply, when determining the appropriate dose of Jodid for the individual patient. This is especially important in new-born infants and children below the age of 4 years. The following recommendations may be taken as a guidance: Ingestion: after meals, with a sufficient amount of liquid, i.e. half a glass of water. Prophylactic administration of iodide tablets must generally be carried out over a period of years, in many cases for life. For treatment of goitre due to iodide deficiency in new-born infants a 2 - 4 week period of treatment is usually sufficient. Children and adolescents usually require treatment for 6 - 12 months and longer. 4.3 CONTRAINDICATION read_full_document