Pays: Pays-Bas
Langue: anglais
Source: HMA (Heads of Medicines Agencies)
levothyroxine sodium 400 µg
Eurovet Animal Health
QH03AA01
Tablet
levothyroxine sodium
Dogs
2010-07-14
Revised: October 2010 AN: 01015/2009 Page 1 of 5 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Forthyron 400 microgram tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: 400µg levothyroxine sodium per tablet equivalent to 388µg levothyroxine For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Tablet White to off white round tablets, scored on one side Tablets divisible into 4 parts 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. 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. After this, thyroid tests should be repeated, then gradual introduction of levothyroxine therapy, starting with 25% of the normal dose, increasing by 25% increments every fortnight until optimal stabilisation is achieved is recommended. Gradual introduction of th Lire le document complet