Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
LEVOTHYROXINE SODIUM
Eurovet Animal Health B.V.
QH03AA01
400 Microgram
Tablets
Hormone
Canine
2006-03-01
SUMMARY OF PRODUCT CHARACTERISTICS 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 CONTRAINDICATIONS 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 therapy is also recommended for dogs with other concurrent illnesses; particularly diabetes melli Přečtěte si celý dokument