البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
spironolactone
Sogeval
QC03DA01
50 mg/tablet
Tablets Chewable
Canine
Neurological Preparations
Authorised
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Tempora 50 mg chewable tablets for dogs. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains ACTIVE SUBSTANCE: Spironolactone............................................................ 50 mg EXCIPIENT(S): For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Chewable tablet. Clover-shaped scored beige tablet. The tablet can be divided into four equal parts. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For use in combination with standard therapy (including diuretic support, where necessary) for the treatment of congestive heart failure caused by degenerative mitral valve disease in dogs. 4.3 CONTRAINDICATIONS Do not use in animals used for or intended for use in breeding. Do not use the product in dogs suffering from hypoadrenocorticism, hyperkalaemia or hyponatraemia. Do not administer spironolactone in conjunction with NSAIDs to dogs with renal insufficiency. Do not use in the case of hypersensitivity to spironolactone or any of the excipients. See section 4.7. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 14/09/2012_ _CRN 7010451_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Kidney function and plasma potassium levels should be evaluated before initiating combined treatment with spironolactone and ACE inhibitors. Unlike in humans, an increased incidence of hyperkalaemia was not observed in clinical trials performed in dogs with this combination. However, in dogs with renal impairment, regular monitoring of renal function and plasma potassium levels is اقرأ الوثيقة كاملة