Fortekor Flavour 5 mg Tablets for Cats and Dogs

Země: Velká Británie

Jazyk: angličtina

Zdroj: VMD (Veterinary Medicines Directorate)

Aktivní složka:

Benazepril Hydrochloride

Dostupné s:

Elanco Europe Ltd

ATC kód:

QC09AA07

INN (Mezinárodní Name):

Benazepril Hydrochloride

Léková forma:

Tablet

Druh předpisu:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutické skupiny:

Cats, Dogs

Terapeutické oblasti:

Cardio Vascular ACE inhibitor

Stav Autorizace:

Authorized

Datum autorizace:

2010-04-28

Charakteristika produktu

Revised: September 2020
AN: 00756/2020
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
FORTEKOR Flavour 5 mg Tablets for Cats and Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Benazepril hydrochloride
5 mg
For the full list of excipients, see section 6.1_._
3.
PHARMACEUTICAL FORM
Tablets.
Beige to light brown, ovaloid, divisible tablets, scored on both
sides.
The tablets can be divided into halves.
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 known cases 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.
Revised: September 2020
AN: 00756/2020
Page 2 of 7
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
No evidence of renal toxicity of the veterinary medicinal product has
been observed (in
dogs or cats) 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 veterinary medicinal product has not
been established in
dogs and cats below 2.5 kg body weight.
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
package leaflet or the label to the physician.
Pregnant women should take special care to avoid accidental oral
exposure because
angiotensin converting enzyme (ACE) inhibitors have been found to
a