BENAZECARE FLAVOUR 5 MG TABLETS FOR DOGS AND CATS.
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
30-05-2024
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Active ingredient:
BENAZEPRIL HYDROCHLORIDE
Available from:
Animalcare Limited
ATC code:
QC09AA07
INN (International Name):
BENAZEPRIL HYDROCHLORIDE
Dosage:
5 Milligram
Pharmaceutical form:
Tablets
Prescription type:
POM
Therapeutic group:
Canine, Feline
Therapeutic area:
Benazepril
Therapeutic indications:
Cardiovascular
Authorization status:
Authorised
Authorization date:
2006-08-24
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Benazecare Flavour 5 mg Tablets for Dogs and Cats.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Benazepril hydrochloride 5 mg
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Beige oblong tablet with breakline on both sides.
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 in dogs.
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 (section 4.7).
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 07/05/2014_
_CRN 7017452_
_page number: 1_
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 hydrochloride has not been established in dogs and cats below 2.5 kg body
weight.
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
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