Benazepril 5mg
Country: Germany
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
05-12-2013
Summary of Product characteristics
(SPC)
05-12-2013
Active ingredient:
benazepril hydrochloride 5 mg
Available from:
Le Vet B.V
ATC code:
QC09AA07
Pharmaceutical form:
Tablet
Therapeutic group:
benazepril
Therapeutic area:
Dogs Non Food
Authorization date:
2011-07-07
Patient Information leaflet
PART I B 1 SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
NL: Benazepril hydrochloride 5 mg tabletten voor honden
DE: Benakor 5 mg
DK: Benakor vet. 5 mg
EL: Benakor F 5 mg ταμπλέτα για σκύλους
HU: Benakor F 5 mg tabletta kutya részére A.U.V.
SE: Benakor vet. 5 mg tablet
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
4.6 mg benazepril (equivalent to 5 mg benazepril hydrochloride)
EXCIPIENT(S):
Colourant: Iron oxides (E172) 0.5 mg
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Yellow oblong divisible tablets, with a break mark on one side.
4. CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dog
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Symptomatic treatment of congestive heart failure with or without adjunct therapy used in the treatment of
heart failure.
4.3 CONTRAINDICATIONS
Do not use in any dog that has evidence of cardiac output failure due to aortic stenosis, mitral valve
stenosis or pulmonary stenosis or in case of hypotension. Do not use in case of known hypersensitivity to
ACE inhibitors or to any of the ingredients of the product.
See section 4.7
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
2
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 plasma urea and
creatinine levels.
Do not abruptly stop or reduce therapy.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADM
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Summary of Product characteristics
PART I B 1 SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
NL: Benazepril hydrochloride 5 mg tabletten voor honden
DE: Benakor 5 mg
DK: Benakor vet. 5 mg
EL: Benakor F 5 mg ταμπλέτα για σκύλους
HU: Benakor F 5 mg tabletta kutya részére A.U.V.
SE: Benakor vet. 5 mg tablet
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Benazepril hydrochloride
5 mg
EXCIPIENT(S):
Colourant: Iron oxides (E172) 0.5 mg
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablets.
Yellow oblong divisible tablets, with a break mark on one side.
4. CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of congestive heart failure.
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
4.5 SPECIAL PRECAUTIONS FOR USE
2
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 chronic kidney disease, it is recommended to monitor plasma creatinine, urea and
erythrocyte counts during therapy.
The efficacy and safety of the product has not been established in dogs below 2.5 kg body weight.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE P
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