Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Levothyroxine sodium
LIVISTO Int'l, S.L.
QH03AA01
Levothyroxine sodium
200 µg/tablet
Tablet
POM: Prescription Only Medicine as defined in relevant national legislation
levothyroxine sodium
Authorised
2021-06-11
Health Products Regulatory Authority 11 June 2021 CRN009P2J Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Kelevo 200 µg tablets for dogs and cats 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: Levothyroxine sodium 200 µg (equivalent to levothyroxine 194 μg) EXCIPIENTS: For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White to off white, round and convex tablet with brown spots and a cross-shaped break line on one side. The tablets can be divided into 2 or 4 equal parts. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of primary and secondary hypothyroidism. 4.3 CONTRAINDICATIONS Do not use in dogs and cats 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 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 animals with concurrent hypoadrenocorticism have a decreased ability to metabolise levothyroxine sodium and therefore an increased risk of thyrotoxicosis. These animals 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 is recommended (starting with 25 % of the normal dose and increasing by 25% increments every fortnight until optimal stabilisation is achieved). Gradual introduction of therapy is als Прочетете целия документ