Prilium 75 mg Powder for Oral Solution

Riik: Suurbritannia

keel: inglise

Allikas: VMD (Veterinary Medicines Directorate)

Toimeaine:

Imidapril Hydrochloride

Saadav alates:

Vetoquinol UK Ltd

ATC kood:

QC09AA16

INN (Rahvusvaheline Nimetus):

Imidapril Hydrochloride

Ravimvorm:

Powder for oral solution

Retsepti tüüp:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutiline rühm:

Dogs

Terapeutiline ala:

Cardio Vascular ACE inhibitor

Volitamisolek:

Expired

Loa andmise kuupäev:

2002-11-21

Toote omadused

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PRILIUM 75 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 75 mg powder for oral solution for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
POWDER/VIAL
Imidapril hydrochloride
75 mg
Sodium benzoate (E 211)
30 mg
Excipient to
0.805 g
SOLUTION AFTER RECONSTITUTION
Imidapril hydrochloride
2.5 mg
Sodium benzoate(E 211)
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 2 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
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.
11834 Prilium 75 mg/-SPC /Renewal V342 DecemberJanuary 076
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ii) Special precautions to be taken by the person administering the