Kelapril 20 mg, Film-coated Tablets for Dogs

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: VMD (Veterinary Medicines Directorate)

מרכיב פעיל:

Benazepril Hydrochloride

זמין מ:

VetViva Richter GmbH

קוד ATC:

QC09AA07

INN (שם בינלאומי):

Benazepril Hydrochloride

טופס פרצבטיות:

Film-coated tablet

סוג מרשם:

POM-V - Prescription Only Medicine – Veterinarian

קבוצה תרפויטית:

Dogs

איזור תרפויטי:

Cardio Vascular ACE inhibitor

מצב אישור:

Authorized

תאריך אישור:

2013-02-12

מאפייני מוצר

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