Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
Levothyroxine sodium
Eurovet Animal Health B.V.
QH03AA01
Levothyroxine sodium
600 µg/tablet
Tablet
POM: Prescription Only Medicine as defined in relevant national legislation
Dogs
levothyroxine sodium
Hormone
Authorised
2011-11-11
Health Products Regulatory Authority 05 October 2020 CRN009SMT Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Thyforon flavoured 600 microgram tablets for dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains: ACTIVE SUBSTANCE : 600 microgram levothyroxine sodium per tablet equivalent to 583 microgram levothyroxine For the 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 CONTRAINDICATIONS Do not use in dogs suffering from uncorrected adrenal insufficiency. Do not use in cases of known hypersensitivity to levothyroxine sodium or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The diagnosis of hypothyroidism should be confirmed with appropriate tests. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals The tablets are flavoured. In order to avoid any accidental ingestion, store tablets out of reach of 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 sta Διαβάστε το πλήρες έγγραφο