BenazeVet 20 mg Tablets for 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:

Dogs

Therapeutic area:

Cardio Vascular ACE inhibitor

Authorization status:

Authorized

Authorization date:

2022-03-29

Summary of Product characteristics

Issued: March 2022
AN: 01294/2020
Page 1 of 6
SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
BenazeVet 20 mg Tablets for Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE: Benazepril hydrochloride 20 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
Beige to light brown, ovaloid, divisible tablets, scored on both
sides.
The tablets can be divided into halves.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Dogs:
Treatment of congestive heart failure.
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.
Issued: March 2022
AN: 01294/2020
Page 2 of 6
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 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 the veterinary medicinal product has not
been established
in dogs below 2.5 kg body weight.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
The product may cause hypotension after ingestion. To avoid accidental
ingestion,
particularly by a child, unused part-tablets should be returned to the
open blister
space and inserted back into the carton. In case of accidental
ingestion, seek medical
advice immediately and show the package leaflet or the label to the
physician.
Angiotensin converting enzyme (ACE) inhibitors have been found to
affect the unborn
child