Bexepril 5 mg Film-coated tablet for dogs

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Benazepril hydrochloride

Fáanlegur frá:

Chanelle Pharmaceuticals Manufacturing Limited

ATC númer:

QC09AA07

INN (Alþjóðlegt nafn):

Benazepril hydrochloride

Skammtar:

5 mg/tablet

Lyfjaform:

Film-coated tablet

Gerð lyfseðils:

POM: Prescription Only Medicine as defined in relevant national legislation

Meðferðarhópur:

Dogs

Lækningarsvæði:

benazepril

Ábendingar:

Cardiovascular

Leyfisstaða:

Authorised

Leyfisdagur:

2010-06-04

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Bexepril 5 mg Film-coated tablet for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each tablet contains:
Benazepril
4.6 mg
(equivalent to Benazepril Hydrochloride 5mg)
EXCIPIENT:
Titanium Dioxide (E171)
0.9348 mg
Iron Oxide Yellow (E172)
0.0476 mg
Quinoline Yellow Aluminum Lake (E104)
0.0176mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
A round yellow 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 10 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. How