ACTIKOR 5 MG FILM-COATED TABLETS FOR DOGS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
30-07-2016
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Active ingredient:
BENAZEPRIL HYDROCHLORIDE PH.EUR. (EQUIVALENT TO BENAZEPRIL)
Available from:
Ecuphar NV
ATC code:
QC09AA07
INN (International Name):
BENAZEPRIL HYDROCHLORIDE PH.EUR. (EQUIVALENT TO BENAZEPRIL)
Dosage:
5 Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
POM
Therapeutic group:
Canine
Therapeutic area:
Benazepril
Therapeutic indications:
Cardiovascular
Authorization status:
Authorised
Authorization date:
2011-06-17
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Actikor 5 mg Film-coated Tablets for Dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains:
ACTIVE SUBSTANCE:
Benazepril 4.6 mg (equivalent to 5 mg of benazepril hydrochloride).
EXCIPIENT(S):
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
Yellow coloured, oval, biconvex, film-coated tablets with a breakline on one side and plain on the other side.
The tablets can be divided into two equal parts.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dog.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Dogs weighing more than 5 kg:
Treatment of congestive heart failure associated with, in particular, dilated cardiomyopathy or mitral insufficiency.
4.3 CONTRAINDICATIONS
Do not use in 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 stenosis or pulmonary stenosis.
Do not use during pregnancy or lactation (section 4.7).
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 15/07/2016_
_CRN 7022293_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
No evidence of renal toxicity to 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 medic
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