Cardalis

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

benazepril hydrochloride, spironolactone

Saatavilla:

Ceva Santé Animale

ATC-koodi:

QC09BA07

INN (Kansainvälinen yleisnimi):

benazepril hydrochloride, spironolactone

Terapeuttinen ryhmä:

Dogs

Terapeuttinen alue:

CARDIOVASCULAR SYSTEM

Käyttöaiheet:

For the treatment of congestive heart failure caused by chronic degenerative valvular disease in dogs (with diuretic support as appropriate).

Tuoteyhteenveto:

Revision: 4

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2012-07-23

Pakkausseloste

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

Valmisteyhteenveto

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