Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
SPIRONOLACTONE
Ceva Santé Animale
QC03DA01
SPIRONOLACTONE
50 mg/tablet
Tablets Chewable
POM
Canine
Spironolactone
Neurological Preparations
Authorised
2016-04-22
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Prilactone Next 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. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _9_ _/_ _0_ _3_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _6_ _4_ _0_ _2_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Kidney function and plasma potassium levels sho Lue koko asiakirja