Kelapril 20 mg, Film-coated Tablets for Dogs

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: VMD (Veterinary Medicines Directorate)

Aktiivinen ainesosa:

Benazepril Hydrochloride

Saatavilla:

Kela N.V.

ATC-koodi:

QC09AA07

INN (Kansainvälinen yleisnimi):

Benazepril Hydrochloride

Lääkemuoto:

Film-coated tablet

Prescription tyyppi:

POM-V - Prescription Only Medicine – Veterinarian

Terapeuttinen ryhmä:

Dogs

Terapeuttinen alue:

Cardio Vascular ACE inhibitor

Valtuutuksen tilan:

Authorized

Valtuutus päivämäärä:

2013-02-12

Valmisteyhteenveto

Revised: October 2019
AN: 00939/2019
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
KELAPRIL 20 mg, film-coated tablets for dogs (BE, CZ, DE, HU, LU, NL,
PL, PT, SK,
UK)
KELAPRIL 20, film-coated tablets for dogs (FR)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains:
ACTIVE SUBSTANCE:
Benazepril Hydrochloride...............20 mg
(equivalent to Benazepril 18.4 mg)
EXCIPIENTS:
Titanium dioxide (E171) 0.52 mg
Iron oxide red (E172) 0.06 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Reddish-pink, oval divisible tablets scored on both sides.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Dogs:
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 in pregnancy or lactation (see section 4.7).
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Page 1 of 6
Revised: October 2019
AN: 00939/2019
4.5
SPECIAL PRECAUTIONS FOR USE
i) Special precautions for use in animals
No evidence of renal toxicity of the veterinary medicinal 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.
ii) Special precautions to be taken by the person administering the
veterinary
medicinal product to animals
Wash hands after use.
To avoid accidental ingestion, particularly by a child, unused
part-tablets should be
returned to the open blister space and inserted back into the carton.
In case of accidental oral ingestion, seek medical advice immediately
and show the
label or the package leaflet to the physician.
Pregnant women should take special care to avoid accidental oral