Riik: Suurbritannia
keel: inglise
Allikas: HMA (Heads of Medicines Agencies)
imidapril chlorohydrate 150 mg
Vetoquinol S.A.
QC09AA16
Powder for oral solution
Imidapril
Dogs
2008-02-20
11835 Prilium 150 mg/FINAL SPC Renewal PRILIUM 150 MG POWDER FOR ORAL SOLUTION Powder for oral solution SUMMARY OF PRODUCT CHARACTERISTICS 11835 Prilium 150 mg/FINAL SPC Renewal 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 11835 Prilium 150 mg/FINAL SPC Renewal The use of ACE inhibitors in dogs with hypovolaemia/dehydration can lead to acute hypot Lugege kogu dokumenti