Enacard Tablets for Dogs 1 mg

País: Reino Unido

Língua: inglês

Origem: VMD (Veterinary Medicines Directorate)

Ingredientes ativos:

Enalapril Maleate

Disponível em:

Boehringer Ingelheim Animal Health UK Ltd

Código ATC:

QC09AA02

DCI (Denominação Comum Internacional):

Enalapril Maleate

Forma farmacêutica:

Tablet

Tipo de prescrição:

POM-V - Prescription Only Medicine – Veterinarian

Grupo terapêutico:

Dogs

Área terapêutica:

Cardio Vascular ACE inhibitor

Status de autorização:

Expired

Data de autorização:

1999-03-12

Características técnicas

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 1 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per tablet:
Enalapril maleate 1.0 mg
Indigotin aluminium lake E132 0.1 mg
Yellow iron oxide E172 0.25 mg
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet. Round non-scored biconvex uncoated green 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.
4.5
SPECIAL PRECAUTIONS FOR USE
i. Special precautions for use in animals
None known but see other sections.
Revised: November 2018
AN: 00955/2018
Page 2 of 6
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 bee