Land: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
spironolactone
Ceva Santé Animale
QC03DA01
spironolactone
Dogs
Diuretics
For use in combination with standard therapy (including diuretic support, where necessary) for the treatment of congestive heart failure caused by valvular regurgitation in dogs.
Revision: 7
Withdrawn
2007-06-20
22 B. PACKAGE LEAFLET 23 PACKAGE LEAFLET Spironolactone Ceva 10 mg tablets for dogs Spironolactone Ceva 40 mg tablets for dogs Spironolactone Ceva 80 mg tablets for dogs 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Ceva Santé Animale 10, av. de La Ballastière 33500 Libourne France Tel: + 33 (0) 5 57 55 40 40 Fax : + 33 (0) 5 57 55 41 98 Manufacturers for batch release: Ceva Santé Animale Z.I. Très le Bois 22600 Loudéac France Catalent Germany Schorndorf GmbH Steinbeistrasse 2 D-73614 Schorndorf Germany 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Spironolactone Ceva 10 mg tablets for dogs Spironolactone Ceva 40 mg tablets for dogs Spironolactone Ceva 80 mg tablets for dogs Spironolactone 3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT Spironolactone Ceva 10 mg contains 10 mg spironolactone Spironolactone Ceva 40 mg contains 40 mg spironolactone Spironolactone Ceva 80 mg contains 80 mg spironolactone 4. INDICATION Spironolactone Ceva tablets are used in combination with standard therapy (including diuretic support, where necessary) for the treatment of congestive heart failure caused by valvular regurgitation in dogs. 24 5. CONTRAINDICATIONS Do not use in dogs suffering from hypoadrenocorticism, hyperkalaemia or hyponatraemia. Do not use in conjunction with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) in dogs with renal insufficiency (kidney impairment/dysfunction). Do not use during pregnancy or lactation. Do not use in animals used for, or intended for use in breeding. 6. ADVERSE REACTIONS A reversible prostatic atrophy (reduction in size) is often observed in entire male dogs. If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon. 7. TARGET SPECIES Dogs. 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Oral use. Administer 2 mg/kg of body weight of spironolactone once daily. NUMBER Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Spironolactone Ceva 10 mg tablets for dogs Spironolactone Ceva 40 mg tablets for dogs Spironolactone Ceva 80 mg tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE:_ _ Spironolactone Ceva 10 mg contains 10 mg spironolactone Spironolactone Ceva 40 mg contains 40 mg spironolactone Spironolactone Ceva 80 mg contains 80 mg spironolactone For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Spironolactone Ceva 10 mg : Brown bisected oval tablet of 10 mm length. Spironolactone Ceva 40 mg : Brown bisected oval tablet of 17 mm length Spironolactone Ceva 80 mg : Brown quadrisected oval tablet of 20 mm length 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 valvular regurgitation in dogs. 4.3 CONTRAINDICATIONS Do not use in dogs suffering from hypoadrenocorticism, hyperkalaemia or hyponatraemia. Do not use in conjunction with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) in dogs with renal insufficiency (kidney impairment/dysfunction). Do not use during pregnancy or lactation. Do not use in animals used for, or intended for use in breeding. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Kidney function and serum potassium levels should be evaluated before initiating combined treatment with spironolactone and Angiotensin Converting Enzyme (ACE) inhibitors. Unlike in humans, an increased incidence of hyperkalaemia was not observed in clinical trials performed in dogs with this 3 combination. However, in dogs with renal impairment regular monitoring of renal function and serum potassium levels is recommended as there may be an increased risk of hyperkalaemia. Dogs treated concomitantly with spironolactone and NSAI Lestu allt skjalið