Land: Storbritannien
Sprog: engelsk
Kilde: HMA (Heads of Medicines Agencies)
spironolactone 10 mg
LABORATOIRE SOGEVAL
QC03DA01
Tablet
spironolactone
Dogs
2012-05-24
1. NAME OF THE VETERINARY MEDICINAL PRODUCT TEMPORA 10 MG CHEWABLE TABLETS FOR DOGS TEMPORA VET (NO) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains ACTIVE SUBSTANCE: Spironolactone ............................................................ 10 mg EXCIPIENT(S): For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Chewable tablet Oblong scored beige tablet. The tablets can be divided into equal halves 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 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 recommended Læs hele dokumentet