产品特点
11834 Prilium 75 mg/-FINAL SPC /Renewal
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PRILIUM 75 MG POWDER FOR ORAL SOLUTION
Powder for oral solution
SUMMARY OF PRODUCT CHARACTERISTICS
11834 Prilium 75 mg/-FINAL SPC /Renewal
2/14
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 su
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