Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Spironolactone
Ceva Santé Animale
QC03DA01
Spironolactone
100 mg/tablet
Chewable tablet
POM: Prescription Only Medicine as defined in relevant national legislation
Dogs
spironolactone
Neurological Preparations
Authorised
2016-04-22
Health Products Regulatory Authority 06 May 2021 CRN009XNY Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Prilactone Next 100 mg chewable tablets for dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains ACTIVE SUBSTANCE: Spironolactone .......................................................... 100 mg EXCIPIENT(S): For the 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 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 cases 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 as there may be an increased risk of hyperkalaemia. Dogs treated concomitantly with spironolactone and NSAIDs should be correctly hydrated. Monitoring of their renal function and plasma potassium levels is recommended before initiation and during treatment with combined therapy (see 4.3). As spironolactone has an antiand Prečítajte si celý dokument