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: 02 January 2024
AN: 03433/2022
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:
Titanium dioxide (E171)
0.52 mg
Iron oxide red (E172)
0.06 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Reddish-pink, oval divisible film-coated tablets scored on both sides.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dog
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of congestive heart failure.
4.3
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 4.7).
Revised: 02 January 2024
AN: 03433/2022
Page 2 of 7
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
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
Wash hands after use.
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 oral ingestion, seek medical advice immediately
and show
the label or the package leaflet to the physician.
Pregnant women should take s