Kelapril 2.5 mg, Film Coated Tablets for Dogs and Cats

Country: Велика Британија

Језик: Енглески

Извор: VMD (Veterinary Medicines Directorate)

Активни састојак:

Benazepril Hydrochloride

Доступно од:

Kela N.V.

АТЦ код:

QC09AA07

INN (Међународно име):

Benazepril Hydrochloride

Фармацеутски облик:

Film-coated tablet

Тип рецептора:

POM-V - Prescription Only Medicine – Veterinarian

Терапеутска група:

Cats, Dogs

Терапеутска област:

Cardio Vascular ACE inhibitor

Статус ауторизације:

Expired

Датум одобрења:

2013-01-09

Карактеристике производа

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