国家: 英国
语言: 英文
来源: VMD (Veterinary Medicines Directorate)
Enalapril Maleate
Boehringer Ingelheim Animal Health UK Ltd
QC09AA02
Enalapril Maleate
Tablet
POM-V - Prescription Only Medicine – Veterinarian
Dogs
Cardio Vascular ACE inhibitor
Expired
1999-03-17
Revised: November 2018 AN: 00955/2018 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ENCARD Tablets for Dogs 10 mg 2. QUALITATIVE AND QUANTITAVIVE COMPOSITION Per tablet: Enalapril maleate 10.0 mg Yellow iron oxide E172 0.5 mg For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Round non-scored biconvex uncoated yellow tablets. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of mild, moderate and severe congestive heart failure in dogs caused by mitral regurgitation or dilated cardiomyopathy as an adjunctive therapy with diuretics. For improved exercise tolerance and increased survival in dogs with mild, moderate and severe heart failure. 4.3 CONTRA-INDICATIONS Do not use in any dog that has evidence of cardiac output failure e.g. aortic stenosis. The product is not recommended for use in pregnant bitches. Safety in breeding dogs has not been established. Do not use with potassium-sparing diuretics. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES See other sections. 4.5 SPECIAL PRECAUTIONS FOR USE i. Special precautions for use in animals None known but see other sections. Revised: November 2018 AN: 00955/2018 Page 2 of 6 ii. Special precautions to be taken by the person administering the medicinal product to animals In case of accidental ingestion, seek urgent medical attention showing the product label to the doctor or nurse. Physicians should contact a Poison Control Centre for advice concerning cases of human consumption. Wash hands after use. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) The product has been demonstrated to be generally well tolerated. In clinical studies, the overall incidence of side effects was not significantly greater with the product than with vehicle tablets. For the most part side effects have been mild and transient in nature and have not required discontinuation of therapy. The following side effects have been reported: AZOTEMIA In clinical trials, 阅读完整的文件