Virbakor 5 mg film-coated tablet for dogs and cats

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Benazepril hydrochloride

Tilgængelig fra:

Virbac

ATC-kode:

QC09AA07

INN (International Name):

Benazepril hydrochloride

Dosering:

5 mg/tablet

Lægemiddelform:

Film-coated tablet

Recept type:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk gruppe:

Cats, Dogs

Terapeutisk område:

benazepril

Terapeutiske indikationer:

Cardiovascular

Autorisation status:

Authorised

Autorisation dato:

2014-07-25

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Virbakor 5 mg film-coated tablet for dogs and cats.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Film-coated tablets.
Beige oblong biconvex film-coated divisible tablets.
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.
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.
Each divisible tablet contains:
Benazepril Hydrochloride
5
mg
(equivalent to Benazepril 4.6 mg)
Excipients:
Titanium Dioxide (E171)
1.929 mg
Iron Oxide Yellow (E172)
0.117 mg
Iron Oxide Red (E172)
0.014 mg
Iron Oxide Black (E172)
0.004 mg
For the full list of excipients, see section 6.1
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4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
No evidence of renal
toxicity of the veterinary medicinal
product
has