Benazecare Flavour 20 mg Tablets for Dogs

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Benazepril hydrochloride

Доступна з:

Ecuphar NV

Код атс:

QC09AA07

ІПН (Міжнародна Ім'я):

Benazepril hydrochloride

Дозування:

20 mg/tablet

Фармацевтична форма:

Tablet

Тип рецепту:

POM: Prescription Only Medicine as defined in relevant national legislation

Терапевтична области:

benazepril

Статус Авторизація:

Authorised

Дата Авторизація:

2006-08-24

Характеристики продукта

Health Products Regulatory Authority
21 March 2019
CRN008XSS
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Benazecare Flavour 20 mg Tablets for Dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each tablet contains 20 mg benazepril hydrochloride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Beige oblong tablet with breakline on both sides.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Dogs:
Treatment of congestive heart failure.
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 during pregnancy or lactation (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 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.
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 converting enzyme
(ACE) inhibitors have been found to affect the unborn child during
pregnancy in humans.
Health Products Regulatory Authority
21 March 2019
CRN008XSS
Page 2 of 4
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
In double-blind clinical trials in dogs with congestive heart failure,
benazepril hydrochloride was well tolerated with an
incidence of adverse reactions low