Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Thiamazole
Le Vet Beheer B.V.
QH03BB02
Thiamazole
5 mg/tablet
Film-coated tablet
POM: Prescription Only Medicine as defined in relevant national legislation
Cats
thiamazole
Miscellaneous
Authorised
2013-09-13
Health Products Regulatory Authority 18 April 2019 CRN000YRM Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Thiafeline 5 mg Film-coated Tablets for Cats 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: Thiamazole 5 mg EXCIPIENT(S): Titanium dioxide (E171) 0.15 mg Sunset Yellow FCF (E110) 0.09 mg Quinoline Yellow WS (E104) 0.075 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Orange 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 cases of hypersensitivity to thiamazole or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS As thiamazole can cause haemoconcentration, cats should always have access to drinking water. 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. Due to the effect thiamazole can have on reducing the glomerular filtration rate, the effect of therapy on renal function should be monitored closely as deterioration of an underlying condition may occur. Haemato Lestu allt skjalið