Bexepril 2.5 mg Film-coated tablet for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Benazepril hydrochloride

Available from:

Chanelle Pharmaceuticals Manufacturing Limited

ATC code:

QC09AA07

INN (International Name):

Benazepril hydrochloride

Dosage:

2.5 mg/tablet

Pharmaceutical form:

Film-coated tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Dogs

Therapeutic area:

benazepril

Therapeutic indications:

Cardiovascular

Authorization status:

Authorised

Authorization date:

2010-06-04

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Bexepril 2.5 mg Film-coated tablet for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each tablet contains:
Benazepril
2.3 mg
(equivalent to Benazepril Hydrochloride 2.5 mg)
EXCIPIENT:
Titanium Dioxide (E171)
0.5 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
A white round biconvex tablet with break line on one side. 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
In dogs weighing more than 5 kg:
Treatment of congestive heart failure associated with, in particular,
dilated cardiomyopathy and/or mitral insufficiency.
4.3 CONTRAINDICATIONS
Do not use in any dog that has evidence of cardiac output failure due,
for example, to aortic stenosis.
Do not use in animals known to be hypersensitive to the active
substance or to any of the excipient(s).
See Section 4.7.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
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4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
No evidence of renal toxicity to the product has been observed in dogs
during clinical trials. However, as is routine in
cases of renal insufficiency, it is recommended to monitor