Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
IMIDAPRIL
Vetoquinol UK Limited
QC09AA
IMIDAPRIL
300 Milligram
Powder for Oral Solution
POM
ACE inhibitors, plain
Cardiovascular
Authorised
2015-11-06
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. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 06/11/2015_ _CRN 7021720_ _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 t Prečítajte si celý dokument