Actikor 5 mg Film-coated Tablets for Dogs

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Benazepril hydrochloride

Dostupné z:

Ecuphar NV

ATC kód:

QC09AA07

INN (Medzinárodný Name):

Benazepril hydrochloride

Dávkovanie:

5 mg/tablet

Forma lieku:

Film-coated tablet

Typ predpisu:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutické skupiny:

Dogs

Terapeutické oblasti:

benazepril

Terapeutické indikácie:

Cardiovascular

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2011-06-17

Súhrn charakteristických

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