Benazecare Flavour 5 mg Tablets for Dogs and Cats

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Benazepril hydrochloride

Disponible depuis:

Ecuphar NV

Code ATC:

QC09AA07

DCI (Dénomination commune internationale):

Benazepril hydrochloride

Dosage:

5 mg/tablet

forme pharmaceutique:

Tablet

Type d'ordonnance:

POM: Prescription Only Medicine as defined in relevant national legislation

Domaine thérapeutique:

benazepril

Statut de autorisation:

Authorised

Date de l'autorisation:

2006-08-24

Résumé des caractéristiques du produit

Health Products Regulatory Authority
19 March 2019
CRN008XSS
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Benazecare Flavour 5 mg Tablets for Dogs and Cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Benazepril hydrochloride 5 mg
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Beige oblong tablet with breakline on both sides.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Dogs
Treatment of congestive heart failure in dogs.
Cats
Reduction of proteinuria associated with chronic kidney disease.
4.3 CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance or to
any of the excipients.
Do not use in cases of hypotension, hypovolaemia, hyponatraemia or
acute renal failure.
Do not use in cases of cardiac output failure due to aortic or
pulmonary stenosis.
Do not use during pregnancy or lactation (section 4.7).
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
No evidence of renal toxicity of the veterinary medicinal product has
been observed (in dogs or cats) during clinical trials,
however, as is routine in cases of chronic kidney disease, it is
recommended to monitor plasma creatinine, urea and erythrocyte
counts during therapy.
The efficacy and safety of benazepril hydrochloridehas not been
established in dogs and cats below 2.5 kg body weight.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
Wash hands after use.
In case of accidental oral ingestion, seek medical advice immediately
and show the label or the package leaflet to the physician.
Pregnant women should take special care to avoid accidental oral
exposure because angiotensin converting enzyme (ACE)
inhibitors have been found to affect the unborn child during pregnancy
in humans.
Health Products Regulatory Authority
19 March 2019
CRN008XSS
Page 2