Država: Irska
Jezik: engleski
Izvor: HMA (Heads of Medicines Agencies)
spironolactone 50 mg
LABORATOIRE SOGEVAL
QC03DA01
Tablet
spironolactone
Dogs
2012-05-23
VETERINARY MEDICINAL PRODUCT TEMPORA 100 MG CHEWABLE TABLETS FOR DOGS PART I B SUMMARY OF THE PRODUCT CHARACTERISTICS Pharmaceutical Form Chewable Tablet 1. NAME OF THE VETERINARY MEDICINAL PRODUCT TEMPORA 100 MG CHEWABLE TABLETS FOR DOGS TEMPORA VET (NO) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains ACTIVE SUBSTANCE: Spironolactone ............................................................ 100 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. 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 hyperk Pročitajte cijeli dokument