Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
benazepril hydrochloride, spironolactone
Ceva Santé Animale
QC09BA07
benazepril hydrochloride, spironolactone
Dogs
CARDIOVASCULAR SYSTEM
For the treatment of congestive heart failure caused by chronic degenerative valvular disease in dogs (with diuretic support as appropriate).
Revision: 4
Authorised
2012-07-23
17 B. PACKAGE LEAFLET 18 PACKAGE LEAFLET Cardalis 2.5 mg/20 mg chewable tablets for dogs Cardalis 5 mg/40 mg chewable tablets for dogs Cardalis 10 mg/80 mg chewable 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 Manufacturers responsible for batch release: Ceva Santé Animale Z.I. Très le Bois 22600 Loudéac France Catalent Germany Schorndorf GmbH Steinbeisstrasse 2 73614 Schorndorf Germany 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Cardalis 2.5 mg/20 mg chewable tablets for dogs Benazepril hydrochloride 2.5 mg, spironolactone 20 mg Cardalis 5 mg/40 mg chewable tablets for dogs Benazepril hydrochloride 5 mg, spironolactone 40 mg Cardalis 10 mg/80 mg chewable tablets for dogs Benazepril hydrochloride 10 mg, spironolactone 80 mg 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each chewable tablet contains: BENAZEPRIL HYDROCHLORIDE (HCL) (benazeprilum HCl) SPIRONOLACTONE (spironolactonum) Cardalis 2.5 mg/20 mg tablets 2.5 mg 20 mg Cardalis 5 mg/40 mg tablets 5 mg 40 mg Cardalis 10 mg/80 mg tablets 10 mg 80 mg The tablets are brown coloured, palatable, oblong shaped with a score line and chewable. 19 4. INDICATION For the treatment of congestive heart failure caused by chronic degenerative valvular disease in dogs (with diuretic support, as appropriate). 5. CONTRAINDICATIONS Do not use during pregnancy and lactation (see section "Pregnancy and lactation"). Do not use in dogs intended or used for breeding. Do not use in dogs suffering from hypoadrenocorticism, hyperkalaemia or hyponatraemia. Do not administer in conjunction with Non Steroidal Anti-Inflammatory Drugs (NSAIDs) to dogs with renal insufficiency. Do not use in case of hypersensitivity to Angiotensin-Converting Enzyme inhibitors (ACE inhibitors) or to any of the excipients. Do not use in cases of cardiac output failure due t Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Cardalis 2.5 mg/20 mg chewable tablets for dogs Cardalis 5 mg/40 mg chewable tablets for dogs Cardalis 10 mg/80 mg chewable tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains: ACTIVE SUBSTANCES: BENAZEPRIL HYDROCHLORIDE (HCL) (benazeprilum HCl) SPIRONOLACTONE (spironolactonum) Cardalis 2.5 mg/20 mg tablets 2.5 mg 20 mg Cardalis 5 mg/40 mg tablets 5 mg 40 mg Cardalis 10 mg/80 mg tablets 10 mg 80 mg EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Chewable tablet. Brown palatable oblong shaped chewable tablets with a score line. 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 the treatment of congestive heart failure caused by chronic degenerative valvular disease in dogs (with diuretic support as appropriate). 4.3 CONTRAINDICATIONS Do not use during pregnancy and lactation (see section 4.7). Do not use in dogs intended or used for breeding. Do not use in dogs suffering from hypoadrenocorticism, hyperkalaemia or hyponatraemia. Do not administer in conjunction with Non Steroidal Anti-Inflammatory Drugs (NSAIDs) to dogs with renal insufficiency. Do not use in case of hypersensitivity to Angiotensin-Converting Enzyme inhibitors (ACE inhibitors) or to any of the excipients. Do not use in cases of cardiac output failure due to aortic or pulmonary stenosis. 3 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 the treatment with benazepril and spironolactone, especially in dogs which may suffer hypoadrenocorticism, hyperkalaemia or hyponatraemia. Unlike in humans, an increased incidence of hyperkalaemia was not observed in clinical trials performed in dogs with this combination. However, regular monitorin Прочетете целия документ