BENAKOR 2.5 MG, FILM-COATED TABLETS FOR CATS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BENAZEPRIL HYDROCHLORIDE

Available from:

Le Vet Beheer B.V.

ATC code:

QC09AA07

INN (International Name):

BENAZEPRIL HYDROCHLORIDE

Dosage:

2.5 Milligram

Pharmaceutical form:

Tablets

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Feline

Therapeutic area:

benazepril

Therapeutic indications:

Cardiovascular

Authorization status:

Authorised

Authorization date:

2012-09-24

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Benakor 2.5 mg, film-coated tablets for cats.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Film-coated tablet.
White oval divisible tablets scored on both sides.
The tablets can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cats:
Reduction of proteinuria associated with chronic kidney disease.
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 (see section 4.7).
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
One tablet contains:
ACTIVE SUBSTANCE:
Benazepril
2.3
mg
(equivalent to 2.5 mg benazepril hydrochloride)
EXCIPIENTS:
Titanium dioxide (E-171)
0.53 mg
For a full list of excipients, see section 6.1.
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4.5 SPECIAL PRECAUTIONS FOR USE
I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS
No evidence of renal
toxicity of the veterinary medicinal
product
has been observed in cats during clinical
trials,
however,
as is routine in cases of chronic kidney disease,
it is recommended to mo