Benefortin Flavour 20 mg Tablets for Dogs

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: VMD (Veterinary Medicines Directorate)

Aktiivinen ainesosa:

Benazepril Hydrochloride

Saatavilla:

Lavet Pharmaceuticals Ltd

ATC-koodi:

QC09AA07

INN (Kansainvälinen yleisnimi):

Benazepril Hydrochloride

Lääkemuoto:

Tablet

Prescription tyyppi:

POM-V - Prescription Only Medicine – Veterinarian

Terapeuttinen ryhmä:

Dogs

Terapeuttinen alue:

Cardio Vascular ACE inhibitor

Valtuutuksen tilan:

Authorized

Valtuutus päivämäärä:

2012-01-25

Valmisteyhteenveto

Revised: June 2020
AN: 00221/2020
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Benefortin Flavour 20 mg tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE Benazepril hydrochloride
20.0 mg (equivalent to Benazepril 18.4 mg)
EXCIPIENTS:
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablets.
Brownish, oval, divisible, tablet scored on both sides. The tablets
can be divided into
equal halves.
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 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 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.
Revised: June 2020
AN: 00221/2020
Page 2 of 6
The chewable tablets are flavoured. In order to avoid any accidental
ingestion, store
tablets out of reach of the animals.
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.
4.6
ADVERSE REACTIONS (FREQUEN