Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
LEVOTHYROXINE SODIUM
Eurovet Animal Health B.V.
QH03AA01
800 Microgram
Tablets
Hormone
Canine
2011-11-25
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Forthyron 800 microgram tablets for dogs. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ONE TABLET CONTAINS: 800 microgram levothyroxine sodium per tablet equivalent to 778 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 CONTRAINDICATIONS 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. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 25/11/2011_ _CRN 7008718_ _page number: 1_ 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 Przeczytaj cały dokument