Benazepril hydrochloride Le Vet 5 mg tablets for dogs
Country: Spain
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 LeVet 5 mg tabletten voor honden
AT: Benakor 5 mg, Tabletten für Hunde
BE: Benakor F 5 mg tabletten voor honden
CZ: Benakor F 5 mg, tablety pro psy
EE: Benakor F 5 mg tabletid koertele
ES: Benakor 5 mg comprimidos para perros
FI: Benakor vet 5 mg tabletti
FR: Benakor F 5 comprimés pour chiens
IE: Benakor 5 mg tablets for dogs
IT: Benakor 5 mg compresse per cani
LU: Benakor F 5 mg comprimés pour chiens
NO: Benakor vet. 5 mg tabletter til hund
PL: Benakor F 5 mg tabletki dla psów
PT: Benakor 5 mg comprimidos para cães
SK: Benakor F 5 mg tablety pre psov
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 in dogs 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
2
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
4.5 SPECIAL PRECAUT
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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 LeVet 5 mg tabletten voor honden
AT: Benakor 5 mg, Tabletten für Hunde
BE: Benakor F 5 mg tabletten voor honden
CZ: Benakor F 5 mg, tablety pro psy
EE: Benakor F 5 mg tabletid koertele
ES: Benakor 5 mg comprimidos para perros
FI: Benakor vet 5 mg tabletti
FR: Benakor F 5 comprimés pour chiens
IE: Benakor 5 mg tablets for dogs
IT: Benakor 5 mg compresse per cani
LU: Benakor F 5 mg comprimés pour chiens
NO: Benakor vet. 5 mg tabletter til hund
PL: Benakor F 5 mg tabletki dla psów
PT: Benakor 5 mg comprimidos para cães
SK: Benakor F 5 mg tablety pre psov
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.
2
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
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
No evidence of renal toxic
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