BenazeVet 2.5 mg Tablets for Cats and Dogs

País: Reino Unido

Língua: inglês

Origem: VMD (Veterinary Medicines Directorate)

Ingredientes ativos:

Benazepril Hydrochloride

Disponível em:

Elanco Europe Ltd

Código ATC:

QC09AA07

DCI (Denominação Comum Internacional):

Benazepril Hydrochloride

Forma farmacêutica:

Tablet

Tipo de prescrição:

POM-V - Prescription Only Medicine – Veterinarian

Grupo terapêutico:

Cats, Dogs

Área terapêutica:

Cardio Vascular ACE inhibitor

Status de autorização:

Authorized

Data de autorização:

2021-03-10

Características técnicas

Issued: March 2021
AN: 01339/2020
Page 1 of 6
SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
BenazeVet 2.5 mg Tablets for cats and dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE: Benazepril hydrochloride 2.5 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Beige, ovaloid, divisible tablets, scored 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.
Cats:
Reduction of proteinuria associated with chronic kidney disease.
4.3
CONTRAINDICATIONS
Do not use in known 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.
4.5
SPECIAL PRECAUTIONS FOR USE
i.
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
Issued: March 2021
AN: 01339/2020
Page 2 of 6
of chronic kidney disease, it is recommended to monitor plasma
creatinine,
urea and erythrocyte counts during therapy.
The efficacy and safety of the veterinary medicinal product has not
been
established in dogs and cats below 2.5 kg bodyweight.
ii.
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 package leaflet or the label 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.
4.6
ADVERS