Prilium 300 mg powder for oral solution for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

imidapril

Available from:

Vetoquinol Ireland Limited

ATC code:

QC09AA

Dosage:

300 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 300 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 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
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.
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 and