מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: VMD (Veterinary Medicines Directorate)
L Thyroxine Sodium
Virbac
QH03AA01
L Thyroxine Sodium
Tablet
POM-V - Prescription Only Medicine – Veterinarian
Dogs
Hormone
Authorized
1997-01-08
PART I.B: SUMMARY OF PRODUCT CHARACTERISTICS PAGE: I.B - 1 PRODUCT: SOLOXINE 0.1 MG TABLET COMPANY: VIRBAC SA DATE: 02/07/2010 DATE ISSUED: 02/07/2010 SUPERSEDES ISSUE: 24/01/2007 1. NAME OF VETERINARY MEDICINAL PRODUCT Soloxine 0.1 mg Tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION EACH TABLET CONTAINS: ACTIVE SUBSTANCE Levothyroxine sodium 0.10 mg EXCIPIENTS Tartrazine E102 0.334 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Small elliptical yellow 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. 4.5 SPECIAL PRECAUTIONS FOR USE I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS Appropriate laboratory tests should be conducted to confirm the diagnosis and ensure correct dosage. PART I.B: SUMMARY OF PRODUCT CHARACTERISTICS PAGE: I.B - 2 PRODUCT: SOLOXINE 0.1 MG TABLET COMPANY: VIRBAC SA DATE: 02/07/2010 DATE ISSUED: 02/07/2010 SUPERSEDES ISSUE: 24/01/2007 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 signs. Dogs with concurrent hypoadrenocorticism should be stabilised with appropriate steroid therapy before commencing treatment with levothyroxine sodium. The effects of thyroxine therapy are slow in being manifested. II) SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS In case of accidenta קרא את המסמך השלם