BenazeVet 2.5 mg Tablets for Cats and Dogs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Benazepril Hydrochloride

Available from:

Elanco Europe Ltd

ATC code:

QC09AA07

INN (International Name):

Benazepril Hydrochloride

Pharmaceutical form:

Tablet

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cats, Dogs

Therapeutic area:

Cardio Vascular ACE inhibitor

Authorization status:

Authorized

Authorization date:

2021-03-10

Summary of Product characteristics

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