Kelapril 5 mg, Film-coated Tablets for Dogs and Cats

Страна: Великобритания

Язык: английский

Источник: VMD (Veterinary Medicines Directorate)

Активный ингредиент:

Benazepril Hydrochloride

Доступна с:

VetViva Richter GmbH

код АТС:

QC09AA07

ИНН (Международная Имя):

Benazepril Hydrochloride

Фармацевтическая форма:

Film-coated tablet

Тип рецепта:

POM-V - Prescription Only Medicine – Veterinarian

Терапевтическая группа:

Cats, Dogs

Терапевтические области:

Cardio Vascular ACE inhibitor

Статус Авторизация:

Authorized

Дата Авторизация:

2013-02-11

Характеристики продукта

Revised: January 2024
AN: 03433/2022
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
KELAPRIL 5 mg, film-coated tablets for dogs and cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Benazepril Hydrochloride
5 mg
(equivalent to Benazepril 4.6 mg)
EXCIPIENTS:
Titanium dioxide (E171) 0.52 mg
Iron oxide yellow (E172) 0.06 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Light yellow, oval divisible film-coated tablets scored on both sides.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dog, cat
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Dog:
Treatment of congestive heart failure.
Cat:
Reduction of proteinuria associated with chronic kidney disease.
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.
Revised: January 2024
AN: 03433/2022
Page 2 of 8
Do not use in pregnancy or lactation (see section 4.7).
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 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 veterinary medicinal product has not
been
established in dogs and cats 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