Benefortin Flavour 5 mg tablets for cats and dogs

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Benazepril hydrochloride

Tillgänglig från:

LAVET Pharmaceuticals Ltd

ATC-kod:

QC09AA07

INN (International namn):

Benazepril hydrochloride

Dos:

5 mg/tablet

Läkemedelsform:

Tablet

Receptbelagda typ:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk grupp:

Cats, Dogs

Terapiområde:

benazepril

Terapeutiska indikationer:

Cardiovascular

Bemyndigande status:

Authorised

Tillstånd datum:

2012-01-27

Produktens egenskaper

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