Enacard Tablets for Dogs 1 mg

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: VMD (Veterinary Medicines Directorate)

Aktif bileşen:

Enalapril Maleate

Mevcut itibaren:

Boehringer Ingelheim Animal Health UK Ltd

ATC kodu:

QC09AA02

INN (International Adı):

Enalapril Maleate

Farmasötik formu:

Tablet

Reçete türü:

POM-V - Prescription Only Medicine – Veterinarian

Terapötik grubu:

Dogs

Terapötik alanı:

Cardio Vascular ACE inhibitor

Yetkilendirme durumu:

Expired

Yetkilendirme tarihi:

1999-03-12

Ürün özellikleri

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