Prilium 75 mg powder for oral solution for dogs
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
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Active ingredient:
imidapril
Available from:
Vetoquinol Ireland Limited
ATC code:
QC09AA
Dosage:
75 Milligram
Pharmaceutical form:
Powder for Oral Solution
Therapeutic area:
Cardiovascular
Authorization status:
Authorised
Summary of Product characteristics
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
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
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.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 28/02/2013_
_CRN 7013964_
_page number: 1_
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
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