Kelapril 20 mg, Film-coated Tablets for Dogs

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:

Dogs

Therapeutic area:

Cardio Vascular ACE inhibitor

Authorization status:

Authorized

Authorization date:

2013-02-12

Summary of Product characteristics

Revised: January 2024
AN: 03431/2022
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
KELAPRIL 20 mg, film-coated tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Benazepril hydrochloride
20 mg
(equivalent to benazepril 18.4 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 red (E172)
0.52 mg
0.06 mg
Reddish-pink, oval divisible film-coated tablets scored on both sides.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Treatment of congestive heart failure.
Revised: January 2024
AN: 03431/2022
Page 2 of 7
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 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:
Wash hands a