Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Thiamazole
CP-Pharma Handelsgesellschaft mbH
QH03BB02
Thiamazole
Oral solution
POM: Prescription Only Medicine as defined in relevant national legislation
thiamazole
2022-12-23
_[Version 8.2,01/2021] _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Thyrasol 5 mg/ml, Oral solution for cats (NL, AT, BE, DE, ES, FR, HU, IE, IT, PL, PT, UK(NI) ) Felithyrol Vet 5 mg/ml, Oral solution for cats (SE/ DK/ FI) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Thiamazole 5.0 mg EXCIPIENTS: Sodium benzoate (E211) 1.5 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral Solution. Colourless to slightly brownish, turbid, viscous solution. 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 cases of hypersensitivity to the active substance or to any of the excipients. Do not use during pregnancy or lactation. Please refer to section 4.7. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES In order to enhance stabilisation of the hyperthyroid patient the same feeding and dosing schedule should be used daily. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals If more than 10 mg of thiamazole per day is required animals should be monitored particularly carefully. As thiamazole can cause haemoconcentration, cats should always have access to drinking water. Use of the product in cats with renal dysfunction should be subject to careful benefit/risk 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 dete Läs hela dokumentet