Kelapril 5 mg, Film-coated Tablets for Dogs and Cats

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Benazepril Hydrochloride

Available from:

VetViva Richter GmbH

ATC code:

QC09AA07

INN (International Name):

Benazepril Hydrochloride

Pharmaceutical form:

Film-coated tablet

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cats, Dogs

Therapeutic area:

Cardio Vascular ACE inhibitor

Authorization status:

Authorized

Authorization date:

2013-02-11

Summary of Product characteristics

Revised: January 2024
AN: 03431/2022
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
KELAPRIL 5 mg, film-coated tablets for dogs and cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Benazepril hydrochloride
5 mg
(equivalent to benazepril 4.6 mg)
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS
AND OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT
INFORMATION IS ESSENTIAL FOR PROPER
ADMINISTRATION OF THE VETERINARY
MEDICINAL PRODUCt
Lactose monohydrate
Cellulose microcrystalline
Starch pregelatinised
Castor oil hydrogenated
Crospovidone
Silica colloidal anhydrous
Coating:
Macrogol poly(vinyl alcohol) grafted
copolymer
Poly(vinyl alcohol)
Silica colloidal anhydrous
Talc
Macrogol 6000
Titanium dioxide (E171)
Iron oxide yellow (E172)
0.52 mg
0.06 mg
Light yellow, oval divisible film-coated tablets scored on both sides.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs, cats
Revised: January 2024
AN: 03431/2022
Page 2 of 8
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Dogs:
Treatment of congestive heart failure.
Cats:
Reduction of proteinuria associated with chronic kidney disease.
3.3
CONTRAINDICATIONS
Do not use in 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 in pregnancy or lactation (see section 3.7).
3.4
SPECIAL WARNINGS
None.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
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.
Specia