Benakor 5 mg tablets for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Benazepril hydrochloride

Available from:

Le Vet BV

ATC code:

QC09AA07

INN (International Name):

Benazepril hydrochloride

Dosage:

5 mg/tablet

Pharmaceutical form:

Tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Dogs

Therapeutic area:

benazepril

Therapeutic indications:

Cardiovascular

Authorization status:

Authorised

Authorization date:

2008-10-24

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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 5 mg tabletten voor honden
CZ: Benakor 5 mg, tablety pro psy
EE: Benakor 5 mg tabletid koertele
ES: Benakor 5 mg comprimidos para perros
FI: Benakor vet 5 mg tabletti
FR: Benakor 5 comprimés pour chiens
IE: Benakor 5 mg tablets for dogs
IT: Benakor 5 mg compresse per cani
LU: Benakor 5 mg comprimés pour chiens
NO: Benakor vet. 5 mg tabletter til hund
PL: Benakor vet. 5 mg tabletki dla psów
PT: Benakor 5 mg comprimidos para cães
SK: Benakor 5 mg tablety pre psov
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Benazepril hydrochloride
5 mg
EXCIPIENT:
Colourant: Iron oxides (E172) 0.5 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
Yellow oblong divisible tablets, with a break mark on both sides.
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
3
None.
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 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 person administering the
veterinary medicinal product to
animals
Wash hands