BenazeVet 5 mg Tablets for Cats and Dogs

Country: Bretland

Tungumál: enska

Heimild: VMD (Veterinary Medicines Directorate)

Virkt innihaldsefni:

Benazepril Hydrochloride

Fáanlegur frá:

Elanco Europe Ltd

ATC númer:

QC09AA07

INN (Alþjóðlegt nafn):

Benazepril Hydrochloride

Lyfjaform:

Tablet

Gerð lyfseðils:

POM-V - Prescription Only Medicine – Veterinarian

Meðferðarhópur:

Cats, Dogs

Lækningarsvæði:

Cardio Vascular ACE inhibitor

Leyfisstaða:

Authorized

Leyfisdagur:

2022-03-29

Vara einkenni

Issued: March 2022
AN: 01293/2020
Page 1 of 7
SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
BenazeVet 5 mg Tablets for cats and dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE: Benazepril hydrochloride 5 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 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.
Issued: March 2022
AN: 01293/2020
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 the veterinary medicinal product has not
been established
in dogs and cats 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