ACTIKOR 20 MG FILM-COATED TABLETS FOR DOGS

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

BENAZEPRIL HYDROCHLORIDE PH.EUR. (EQUIVALENT TO BENAZEPRIL)

제공처:

Ecuphar NV

ATC 코드:

QC09AA07

INN (International Name):

BENAZEPRIL HYDROCHLORIDE PH.EUR. (EQUIVALENT TO BENAZEPRIL)

복용량:

20 Milligram

약제 형태:

Film Coated Tablet

처방전 유형:

POM

치료 그룹:

Canine

치료 영역:

Benazepril

치료 징후:

Cardiovascular

승인 상태:

Authorised

승인 날짜:

2011-06-17

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Actikor 20 mg Film-coated Tablets for Dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains:
ACTIVE SUBSTANCE:
Benazepril 18.4 mg (equivalent to 20 mg of benazepril hydrochloride).
EXCIPIENT(S):
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
Tan 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 20 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