País: Austria
Idioma: inglés
Fuente: HMA (Heads of Medicines Agencies)
levothyroxine sodium 200 µg
Eurovet Animal Health
QH03AA01
Tablet
levothyroxine sodium
Dogs
2011-10-26
Revised: December 2011 AN: 01146/2010 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Forthyron flavoured 200 microgram tablets for dogs UK: Thyforon flavoured 200 microgram tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ONE TABLET CONTAINS: 200 microgram levothyroxine sodium per tablet equivalent to 194 microgram levothyroxine For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Tablet Off white round tablet with brown spots, quadrisect with side scores The tablets may be divided into halves or quarters 4. CLINICAL PARTICULARS 4.1. TARGET SPECIES Dogs. 4.2. INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of hypothyroidism in dogs. 4.3. CONTRA-INDICATIONS Do not use in dogs suffering from uncorrected adrenal insufficiency. Do not use in cases of known hypersensitivity to levothyroxine sodium. 4.4. SPECIAL WARNINGS FOR EACH TARGET SPECIES The diagnosis hypothyroidism should be confirmed with appropriate tests. 4.5. SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS A sudden increase in demand for oxygen delivery to peripheral tissues, plus the chronotropic effects of levothyroxine sodium, may place undue stress on a poorly functioning heart, causing decompensation and signs of congestive heart failure. Hypothyroid dogs suffering from hypoadrenocorticism have a decreased ability to metabolise levothyroxine sodium and therefore an increased risk of thyrotoxicosis. Dogs with concurrent hypoadrenocorticism and hypothyroidism should be stabilised with glucocorticoid and mineralocorticoid treatment prior to treatment with levothyroxine sodium to avoid precipitating a hypoadrenocortical crisis. Leer el documento completo