MiPet Benazapet 20 mg Tablets for Dogs

Land: Verenigd Koninkrijk

Taal: Engels

Bron: VMD (Veterinary Medicines Directorate)

Werkstoffen:

Benazepril Hydrochloride

Beschikbaar vanaf:

Elanco Europe Ltd

ATC-code:

QC09AA07

INN (Algemene Internationale Benaming):

Benazepril Hydrochloride

farmaceutische vorm:

Tablet

Prescription-type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutische categorie:

Dogs

Therapeutisch gebied:

Cardio Vascular ACE inhibitor

Autorisatie-status:

Authorized

Autorisatie datum:

2015-10-15

Productkenmerken

Revised: January 2021
AN: 01522/2020
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
MiPet Benazapet 20 mg Tablets for Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Active substance
Benazepril hydrochloride
20 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Beige to light brown, ovaloid, divisible, tablet scored on both sides.
The tablets can be divided into halves.
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 cases of cardiac output failure due to aortic or
pulmonary stenosis.
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 pregnancy or lactation (section 4.7).
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Revised: January 2021
AN: 01522/2020
Page 2 of 6
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
The efficacy and safety of MiPet Benazapet has not been established in
dogs below 2.5 kg body weight.
No evidence of renal toxicity to benazepril hydrochloride 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.
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 exposure because
angiotensin converting enzyme (ACE) inhibitors have been found to
affect
the unborn child during pregnancy in humans.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
In double-blind clinical trials in dogs with