Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Levothyroxine sodium
Virbac S.A.
QH03AA01
Levothyroxine sodium
0.5 mg/tablet
Tablet
POM: Prescription Only Medicine as defined in relevant national legislation
Dogs
levothyroxine sodium
Hormone
Authorised
2007-01-19
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Soloxine 0.5 mg Tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Substance Levothyroxine Sodium 0.50 mg For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Small elliptical white tablets. Scored on the face of each tablet , strength in milligrams to the right and the word SOLOXINE on the reverse. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the long term treatment of thyroid insufficiency in dogs. 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to the active ingredient. Do not use in animals suffering from thyrotoxicosis or uncorrected adrenal insufficiency 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _0_ _1_ _/_ _0_ _2_ _/_ _2_ _0_ _1_ _6_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _2_ _9_ _6_ _2_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTION(S) FOR USE IN ANIMALS Appropriate laboratory tests should be conducted to confirm the diagnosis and ensure correct dosage. Caution should be exercised in the treatment of dogs with clinically significant cardiac disease, hypertension or any disease rendering the animal susceptible to sharply increased metabolic rate. In such cases, consideration should be given to reducing the starting dose, increasing the dose at intervals whilst monitoring all clinical sign Les hele dokumentet