Benefortin Flavour 5 mg Tablets for Cats and Dogs

Pays: Royaume-Uni

Langue: anglais

Source: VMD (Veterinary Medicines Directorate)

Ingrédients actifs:

Benazepril Hydrochloride

Disponible depuis:

Lavet Pharmaceuticals Ltd

Code ATC:

QC09AA07

DCI (Dénomination commune internationale):

Benazepril Hydrochloride

forme pharmaceutique:

Tablet

Type d'ordonnance:

POM-V - Prescription Only Medicine – Veterinarian

Groupe thérapeutique:

Cats, Dogs

Domaine thérapeutique:

Cardio Vascular ACE inhibitor

Statut de autorisation:

Authorized

Date de l'autorisation:

2012-01-25

Résumé des caractéristiques du produit

Revised: June 2020
AN: 00221/2020
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Benefortin Flavour 5 mg tablets for cats and dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE Benazepril hydrochloride: 5.0 mg(equivalent to
Benazepril 4,60 mg)
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
Brownish, oval, divisible, tablet scored on both sides. The tablets
can be divided into
equal halves.
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.
Cats:
Reduction of proteinuria associated with chronic kidney disease.
4.3
CONTRAINDICATIONS
Do not use in cases 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.
Revised: June 2020
AN: 00221/2020
Page 2 of 7
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 has not been
established in dogs
and cats below 2.5 kg body weight.
The chewable tablets are flavoured. In order to avoid any accidental
ingestion, store
tablets out of reach of the animals.
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