País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
IMIDAPRIL
Vetoquinol UK Limited
QC09AA
IMIDAPRIL
150 Milligram
Powder for Oral Solution
POM: Prescription Only Medicine as defined in relevant national legislation
ACE inhibitors, plain
Cardiovascular
Authorised
2015-11-06
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 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 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. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _0_ _6_ _/_ _1_ _1_ _/_ _2_ _0_ _1_ _5_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _1_ _7_ _2_ _0_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.5 SPECIAL PRECAUTIONS FOR USE i) Special precautions for use in animals T Leia o documento completo