Kelapril 2.5 mg, Film Coated Tablets for Dogs and Cats

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: VMD (Veterinary Medicines Directorate)

מרכיב פעיל:

Benazepril Hydrochloride

זמין מ:

Kela N.V.

קוד ATC:

QC09AA07

INN (שם בינלאומי):

Benazepril Hydrochloride

טופס פרצבטיות:

Film-coated tablet

סוג מרשם:

POM-V - Prescription Only Medicine – Veterinarian

קבוצה תרפויטית:

Cats, Dogs

איזור תרפויטי:

Cardio Vascular ACE inhibitor

מצב אישור:

Expired

תאריך אישור:

2013-01-09

מאפייני מוצר

Revised: May 2013
AN: 01690/2012
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
KELAPRIL 2.5 mg, film coated tablets for dogs and cats
[FR] KELAPRIL 2,5 film coated tablets for dogs and cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains:
ACTIVE SUBSTANCE:
2.3 mg benazepril
(equivalent to 2.5 mg benazepril hydrochloride)
EXCIPIENTS:
Titanium dioxide (E-171) 0,53 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
White, oval divisible tablets scored on both sides.
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 case 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: May 2013
AN: 01690/2012
Page 2 of 7
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
4.5
SPECIAL PRECAUTIONS FOR USE
i.
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 product has not been established in
dogs
and cats below 2.5 kg body weight.
ii.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
Wash hands after use.
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 special care to avoid accidental oral
exposure because angiotensin c