Actikor 20 mg Film-coated Tablets for Dogs

Држава: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Benazepril hydrochloride

Доступно од:

Ecuphar NV

АТЦ код:

QC09AA07

INN (Међународно име):

Benazepril hydrochloride

Дозирање:

20 mg/tablet

Фармацеутски облик:

Film-coated tablet

Тип рецептора:

POM: Prescription Only Medicine as defined in relevant national legislation

Терапеутска група:

Dogs

Терапеутска област:

benazepril

Терапеутске индикације:

Cardiovascular

Статус ауторизације:

Authorised

Датум одобрења:

2011-06-17

Карактеристике производа

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.
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4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
No evidence of renal toxicity to the veterina