국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
RAMIPRIL
aniMedica GmbH
QC09AA05
RAMIPRIL
1.25 Milligram
Tablets
POM
Canine
Ramipril
Cardiovascular
Authorised
2012-07-13
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Prilocard 1.25 mg tablets for dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Active substance: Ramipril 1.25 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets. White round biconvex tablets, imprinted with ‘B’ on one side of the tablet and ‘48’ on the other. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For treatment of congestive heart failure (equivalent to New York Heart Association [NYHA] classes II, III and IV) caused by valvular insufficiency due to endocardiosis or cardiomyopathy. The preparation may if applicable be administered concomitantly with furosemide (diuretic) and/or the cardiac glycosides digoxin or methyl digoxin. In patients treated concomitantly with ramipril and furosemide, the diuretic dose may be reduced to achieve the same diuretic effect as in treatment with furosemide alone. 4.3 CONTRAINDICATIONS Do not use in haemodynamically-related stenoses (e.g. aortic stenosis, mitral stenosis) nor in cases of obstructive hypertrophic cardiomyopathy. Do not use in cases of hypersensitivity to the active substance, ACE-inhibitors or to any of the excipient(s). See Section 4.7 for use in Pregnancy and Lactation Class Clinical symptoms II Fatigue, dyspnoea, cough etc. seen in normal activity. Ascites may occur at this stage. III Comfortable at rest, but capacity for activity minimal. IV Incapable of any activity. Clinical symptoms of disablement occur even at rest. 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ 전체 문서 읽기