Prilenal 5 mg, Tablets

Kraj: Wielka Brytania

Język: angielski

Źródło: VMD (Veterinary Medicines Directorate)

Składnik aktywny:

Enalapril Maleate

Dostępny od:

Ceva Animal Health Ltd

Kod ATC:

QC09AA02

INN (International Nazwa):

Enalapril Maleate

Forma farmaceutyczna:

Tablet

Typ recepty:

POM-V - Prescription Only Medicine – Veterinarian

Grupa terapeutyczna:

Dogs

Dziedzina terapeutyczna:

Cardio Vascular ACE inhibitor

Status autoryzacji:

Expired

Data autoryzacji:

2005-09-28

Charakterystyka produktu

Revised: February 2015
AN: 01244/2014
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
PRILENAL 5 mg, tablets [AT, BE, CZ, DE, EL, ES, HU, IT, LU, NL, PL,
PT, SK, UK]
PRILENAL 8-15 kg, tablets [FR]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains:
ACTIVE SUBSTANCE:
Enalapril maleate
5 mg
(Which corresponds to 3.822 mg of enalapril base)
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Brown spotted white round tablet.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment
of
mild,
moderate
or
severe
congestive
heart
failure,
caused
by
mitral
regurgitation
or
dilated
cardiomyopathy,
as
an
adjunctive
therapy
with
diuretics
(furosemide, whether associated or not with digoxin).
4.3
CONTRAINDICATIONS
Do not use in case of hypersensitivity to enalapril or to any of the
excipients.
Do not use in dogs with evidence of cardiac output failure (e.g.
aortic stenosis, mitral
stenosis, obstructive cardiomyopathy).
See section 4.7.
4.4
SPECIAL WARNINGS
Pre renal azotemia generally results from hypotension due to
cardio-vascular insufficiency.
Substances that deplete blood volume, such as diuretics, or with a
vasodilator effect, such
as ACE inhibitors, may contribute to lowering systemic blood pressure.
This may create a hypotensive state or exacerbate an existing
hypotensive situation and
result in pre renal azotemia.
Revised: February 2015
AN: 01244/2014
Page 2 of 5
Dogs with no detectable renal disease may develop mild and transient
increases in blood
urea nitrogen or serum creatinine when the product is administered
concomitantly with a
diuretic.
The diuretic and/or enalapril dose should be reduced if clinical signs
of hypotension or
azotemia appear or if the blood concentration of urea nitrogen and/or
creatinine increases
significantly above the values observed before treatment.
Should clinical signs of overdose occur (azotemia) after the dose is
increased from once
daily to twice