Benazecare 5
Country: Netherlands
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
25-08-2013
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Active ingredient:
benazepril hydrochloride 5 mg
Available from:
Animalcare Limited
ATC code:
QC09AA07
Pharmaceutical form:
Film coated tablet
Therapeutic group:
benazepril
Therapeutic area:
Dogs
Authorization date:
2011-10-28
Summary of Product characteristics
Revised: May 2012
AN: 00040/2012
Page 1 of 7
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 5mg
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.
Revised: May 2012
AN: 00040/2012
Page 2 of 7
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 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
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