Vetpril 5 mg Film-Coated Tablet for Dogs and Cats

Country: Bretland

Tungumál: enska

Heimild: VMD (Veterinary Medicines Directorate)

Virkt innihaldsefni:

Benazepril Hydrochloride

Fáanlegur frá:

Vetpharma Animal Health, S.L

ATC númer:

QC09AA07

INN (Alþjóðlegt nafn):

Benazepril Hydrochloride

Lyfjaform:

Film-coated tablet

Gerð lyfseðils:

POM-V - Prescription Only Medicine – Veterinarian

Meðferðarhópur:

Cats, Dogs

Lækningarsvæði:

Cardio Vascular ACE inhibitor

Leyfisstaða:

Expired

Leyfisdagur:

2013-01-28

Vara einkenni

Issued: January 2013
AN: 01908/2011
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT:
VETPRIL
5 mg film-coated tablet for dogs and cats
[ES, PT, UK]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
EACH DIVISIBLE TABLET CONTAINS:
Benazepril .....................................4.6 mg
(equivalent to Benazepril Hydrochloride 5 mg)
EXCIPIENTS :
Titanium dioxide (E171).................1.929 mg
Iron oxide yellow (E172) ................0.117 mg
Iron oxide red (E172).....................0.014 mg
Iron oxide black (E172)..................0.004 mg
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM:
Film-coated tablet
Beige oblong biconvex film-coated divisible tablets
4. CLINICAL PARTICULARS:
4.1TARGET SPECIES:
Dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING TARGET SPECIES:
In DOGS: weighing more than 5 kg bw: Treatment of congestive heart
failure.
In CATS: Reduction of proteinuria associated with chronic kidney
disease.
Issued: January 2013
AN: 01908/2011
Page 2 of 8
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
4.5 SPECIAL PRECAUTIONS FOR USE
I.
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
No evidence of renal toxicity to benazepril 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.
II.
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 i