Prilium 150 mg Powder for Oral Solution for Dogs

Země: Velká Británie

Jazyk: angličtina

Zdroj: VMD (Veterinary Medicines Directorate)

Aktivní složka:

Imidapril Hydrochloride

Dostupné s:

Vetoquinol UK Ltd

ATC kód:

QC09AA16

INN (Mezinárodní Name):

Imidapril Hydrochloride

Léková forma:

Powder for oral solution

Druh předpisu:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutické skupiny:

Dogs

Terapeutické oblasti:

Cardio Vascular ACE inhibitor

Stav Autorizace:

Expired

Datum autorizace:

2002-11-21

Charakteristika produktu

11835 Prilium 150 mg/ SPC Renewal V4 January 07
PRILIUM 150 MG POWDER FOR ORAL SOLUTION
Powder for oral solution
SUMMARY OF PRODUCT CHARACTERISTICS
11835 Prilium 150 mg/ SPC Renewal V4 January 07
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
PRILIUM 150 mg powder for oral solution for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
POWDER/VIAL
Imidapril hydrochloride
150 mg
Sodium benzoate (E211)
30 mg
Excipient to
0.880 g
SOLUTION AFTER RECONSTITUTION
Imidapril hydrochloride
5.0 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 4 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.
11835 Prilium 150 mg/ SPC Renewal V4 January 07
ii) Special precautions to be taken by the person administering the
medicinal product to animals
In case of accide