Benefortin Flavour 5 mg tablets for cats and dogs

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Benazepril hydrochloride

Fáanlegur frá:

LAVET Pharmaceuticals Ltd

ATC númer:

QC09AA07

INN (Alþjóðlegt nafn):

Benazepril hydrochloride

Skammtar:

5 mg/tablet

Lyfjaform:

Tablet

Gerð lyfseðils:

POM: Prescription Only Medicine as defined in relevant national legislation

Meðferðarhópur:

Cats, Dogs

Lækningarsvæði:

benazepril

Ábendingar:

Cardiovascular

Leyfisstaða:

Authorised

Leyfisdagur:

2012-01-27

Vara einkenni

Health Products Regulatory Authority
24 June 2020
CRN009RKY
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Benefortin Flavour 5 mg tablets for cats and dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE
Benazepril hydrochloride: 5.0 mg (equivalent to Benazepril 4.60 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 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 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 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 benazepril has not
been established in dogs and cats below 2.5 kg body
weight.
The chewable tablets are flavoured. In order to avoid any accidental
ingestion, store tablets out of reach of the animals.
Health Products Regulatory Authority
24 June 2020
CRN009RKY
Page 2 of 5
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 lea