Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
L Thyroxine Sodium
Eurovet Animal Health B.V.
QH03A
L Thyroxine Sodium
Expired
Issued: November 2011 AN: 01161/2010 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Forthyron 600 microgram tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ONE TABLET CONTAINS: 600 microgram levothyroxine sodium per tablet equivalent to 583 microgram 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 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. 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 therapy is also recommended for dogs with other concurrent illnesses; particularly in dogs with cardiac disease, diabetes mellitus and renal or Read the complete document