Fortekor flavour 20 mg tablets for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

benazepril hydrochloride

Available from:

Novartis Animal Health UK Ltd

ATC code:

QC09AA07

Dosage:

20 Milligram

Pharmaceutical form:

Tablets

Therapeutic group:

Canine

Therapeutic area:

Cardiovascular

Authorization status:

Authorised

Summary of Product characteristics

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
FORTEKOR Flavour 20 mg tablets for dogs.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE: Benazepril hydrochloride
20 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets.
Beige to light brown, ovaloid, divisible, tablet scored on both sides.
The tablets can be divided into equal 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 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 (section 4.7).
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 31/07/2012_
_CRN 7012474_
_page number: 1_
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 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.
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
                                
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