Benakor 5 mg tablets for dogs

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Benazepril hydrochloride

Disponibil de la:

Le Vet BV

Codul ATC:

QC09AA07

INN (nume internaţional):

Benazepril hydrochloride

Dozare:

5 mg/tablet

Forma farmaceutică:

Tablet

Tip de prescriptie medicala:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupul Terapeutică:

Dogs

Zonă Terapeutică:

benazepril

Indicații terapeutice:

Cardiovascular

Statutul autorizaţiei:

Authorised

Data de autorizare:

2008-10-24

Caracteristicilor produsului

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