Prilium 300 mg Powder for Oral Solution for Dogs

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: VMD (Veterinary Medicines Directorate)

Wirkstoff:

Imidapril Hydrochloride

Verfügbar ab:

Vetoquinol UK Ltd

ATC-Code:

QC09AA16

INN (Internationale Bezeichnung):

Imidapril Hydrochloride

Darreichungsform:

Powder for oral solution

Verschreibungstyp:

POM-V - Prescription Only Medicine – Veterinarian

Therapiegruppe:

Dogs

Therapiebereich:

Cardio Vascular ACE inhibitor

Berechtigungsstatus:

Expired

Berechtigungsdatum:

2002-11-21

Fachinformation

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PRILIUM 300 MG POWDER FOR ORAL SOLUTION
Powder for oral solution
SUMMARY OF PRODUCT CHARACTERISTICS
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
PRILIUM 300 mg powder for oral solution for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
POWDER/VIAL
Imidapril hydrochloride
300 mg
Sodium benzoate(E211)
30 mg
Excipient to
1.030 g
SOLUTION AFTER RECONSTITUTION
Imidapril hydrochloride
10.0 mg
Sodium benzoate(E211)
1.0 mg
Excipient to
1 ml
For full list of excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Powder for oral solution
Vial containing a white powder. After reconstitution, the solution is
limpid and colourless.
4.
CLINICAL PARTICULARS
4.1. Target species
Dogs weighing over 8 kg
4.2. Indications for use, specifying the target species
In dogs: treatment of moderate to severe heart failure caused by
mitral regurgitation or by dilated
cardiomyopathy.
4.3. Contraindications
Do not use in dogs with low blood pressure.
Do not use in dogs with acute renal insufficiency.
Do not use in dogs with congenital heart disease
Do not use in dogs hypersensitive to an ACE inhibitor
Do not use in dogs with hemodynamically relevant stenoses(aortic
stenosis, mitral valve stenosis, pulmonal
stenosis)
Do not use in dogs with obstructive hypertrophic cardiomyopathy
4.4. Special warnings for each target species
None
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4.5. Special precautions for use
i) Special precautions for use in animals
The use of ACE inhibitors in dogs with hypovolaemia/dehydration can
lead to
acute hypotension. In such cases the fluid and electrolyte balance
should be
restored immediately and treatment suspended until it has been
stabilised.
Parameters used for monitoring renal function should be checked at the
beginning of the treatment and at regular time intervals thereafter.
ii) Special precautions to be taken by the person administering the
medicinal product to animals
In case of