Fortekor Flavour 5 mg Tablets for cats and dogs

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Benazepril hydrochloride

Prieinama:

Elanco GmbH

ATC kodas:

QC09AA07

INN (Tarptautinis Pavadinimas):

Benazepril hydrochloride

Dozė:

5 mg/tablet

Vaisto forma:

Tablet

Recepto tipas:

POM: Prescription Only Medicine as defined in relevant national legislation

Gydymo sritis:

benazepril

Autorizacija statusas:

Authorised

Leidimo data:

2016-04-22

Prekės savybės

1
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 (as hydrochloride)
4.6 mg
(equivalent to 5 mg benazepril hydrochloride)
EXCIPIENT(S):_ _
_ _
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
Cellulose microcrystalline
Crospovidone
Povidone K30
Basic butylated methacrylate copolymer
Silicon dioxide anhydrous
Silica colloidal anhydrous
Sodium laurilsulphate
Dibutyl sebacate
Stearic acid
Yeast powder
Artificial powdered beef flavour
Beige to light brown, ovaloid, divisible tablets, scored on both
sides.
The tablets can be divided into equal halves.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs and cats.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Dogs:
Treatment of congestive heart failure.
Cats:
Reduction of proteinuria associated with chronic kidney disease.
3.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
2
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 3.7).
3.4
SPECIAL WARNINGS
None.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
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:
Angiotensin converting enzyme (ACE) inhibitors have been found to
affect the unborn child during
pregnancy in humans. Pregnant women should take special