Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
THIAMAZOLE
Norbrook Laboratories Limited
QH03BB02
THIAMAZOLE
5 Mg/Ml
Oral Solution
POM
Feline
Thiamazole
Miscellaneous
Authorised
2016-06-10
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Thyronorm 5 mg/ml Oral Solution for Cats 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Thiamazole 5 mg EXCIPIENT: Sodium Benzoate (E211) 1.5 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution An off-white to light yellow opaque 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 pregnant or lactating females. Please refer to section 4.7. Do not use in case of hypersensitivity to the active substance or to any of the excipients. 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. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 10/06/2016_ _CRN 7020069_ _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. Прочитайте повний документ