Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
THIAMAZOLE
Le Vet Beheer B.V.
QH03BB02
THIAMAZOLE
2.5 Milligram
Tablets
POM
Feline
Thiamazole
Miscellaneous
Authorised
2013-09-13
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Thiafeline 2.5 mg Film-coated Tablets for Cats 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: Thiamazole 2.5 mg EXCIPIENT(S): Titanium dioxide (E171) 0.45 mg Carmoisine (E122) 0.009 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Pink biconvex tablets 5.5 mm diameter. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the stabilisation of hyperthyroidism in cats prior to surgical thyroidectomy. For the long-term treatment of feline hyperthyroidism. 4.3 CONTRAINDICATIONS Do not use in cats suffering from systemic disease such as primary liver disease or diabetes mellitus. Do not use in cats showing signs of autoimmune disease. Do not use in animals with disorders of white blood cells, such as neutropenia and lymphopenia. Do not use in animals with platelet disorders and coagulopathies (particularly thrombocytopenia). Do not use in pregnant or lactating females. Refer to section 4.7. Do not use in cats with hypersensitivity to thiamazole or the excipient, polyethylene glycol. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES As thiamazole can cause haemoconcentration, cats should always have access to drinking water. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 25/02/2015_ _CRN 7019806_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS If more than 10 mg per day is required animals should be monitored particularly carefully. Use of the product in cats with renal dysfunction should be subject to careful risk : benefit assessment by the clinician. Read the complete document