Enacard Tablets for Dogs 2.5 mg

Država: Velika Britanija

Jezik: engleski

Izvor: VMD (Veterinary Medicines Directorate)

Aktivni sastojci:

Enalapril Maleate

Dostupno od:

Boehringer Ingelheim Animal Health UK Ltd

ATC koda:

QC09AA02

INN (International ime):

Enalapril Maleate

Farmaceutski oblik:

Tablet

Tip recepta:

POM-V - Prescription Only Medicine – Veterinarian

Terapijska grupa:

Dogs

Područje terapije:

Cardio Vascular ACE inhibitor

Status autorizacije:

Expired

Datum autorizacije:

1999-03-17

Svojstava lijeka

Revised: November 2018
AN: 00955/2018
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Enacard Tablets for Dogs 2.5 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per tablet:
Enalapril maleate 2.5 mg
Indigotin aluminium lake E132 0.05 mg
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet. Round non-scored biconvex uncoated blue tablets.
4.
CLINICAL PARTICULARS
4.1.
TARGET SPECIES
Dogs.
4.2.
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of mild, moderate and severe congestive heart failure in
dogs caused
by mitral regurgitation or dilated cardiomyopathy as an adjunctive
therapy with
diuretics. For improved exercise tolerance and increased survival in
dogs with
mild, moderate and severe heart failure.
4.3.
CONTRA-INDICATIONS
Do not use in any dog that has evidence of cardiac output failure e.g.
aortic
stenosis.
The product is not recommended for use in pregnant bitches. Safety in
breeding
dogs has not been established.
Do not use with potassium-sparing diuretics.
4.4.
SPECIAL WARNINGS FOR EACH TARGET SPECIES
See other sections.
Revised: November 2018
AN: 00955/2018
Page 2 of 6
4.5.
SPECIAL PRECAUTIONS FOR USE
i)
Special precautions for use in animals
None known but see other sections.
ii)
Special precautions to be taken by the person administering the
medicinal product to the animals
In case of accidental ingestion, seek urgent medical attention
showing the product label to the doctor or nurse. Physicians should
contact a Poison Control Centre for advice concerning cases of
human consumption.
Wash hands after use.
4.6.
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
The product has been demonstrated to be generally well tolerated. In
clinical
studies, the overall incidence of side effects was not significantly
greater with
the product than with vehicle tablets. For the most part side effects
have been
mild and transient in nature and have not required discontinuation of
therapy.
The following side effects have been reported:
AZOTEMIA
In