BenazeVet 2.5 mg Tablets for cats and dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Benazepril hydochloride

Available from:

Elanco GmbH

ATC code:

QC09AA07

INN (International Name):

Benazepril hydochloride

Dosage:

2.5 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

benazepril

Authorization status:

Authorised

Authorization date:

2020-11-20

Summary of Product characteristics

Health Products Regulatory Authority
15 January 2021
CRN00C1TW
Page 1 of 5
SUMMARY OF 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 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.
Health Products Regulatory Authority
15 January 2021
CRN00C1TW
Page 2 of 5
Pregnant women should take special care to avoid accidental oral
exposure because angiotensin converting enzyme (ACE)
inhibitors have been found to affect the u