Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Benazepril Hydrochloride
Vetpharma Animal Health, S.L
QC09AA07
Benazepril Hydrochloride
Film-coated tablet
POM-V - Prescription Only Medicine – Veterinarian
Cats, Dogs
Cardio Vascular ACE inhibitor
Expired
2013-01-28
Issued: January 2013 AN: 01908/2011 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT: VETPRIL 5 mg film-coated tablet for dogs and cats [ES, PT, UK] 2. QUALITATIVE AND QUANTITATIVE COMPOSITION: EACH DIVISIBLE TABLET CONTAINS: Benazepril .....................................4.6 mg (equivalent to Benazepril Hydrochloride 5 mg) EXCIPIENTS : Titanium dioxide (E171).................1.929 mg Iron oxide yellow (E172) ................0.117 mg Iron oxide red (E172).....................0.014 mg Iron oxide black (E172)..................0.004 mg For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM: Film-coated tablet Beige oblong biconvex film-coated divisible tablets 4. CLINICAL PARTICULARS: 4.1TARGET SPECIES: Dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING TARGET SPECIES: In DOGS: weighing more than 5 kg bw: Treatment of congestive heart failure. In CATS: Reduction of proteinuria associated with chronic kidney disease. Issued: January 2013 AN: 01908/2011 Page 2 of 8 4.3. CONTRAINDICATIONS: Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not use in cases of hypotension, hypovolaemia, hyponatraemia or acute renal failure. Do not use in cases of cardiac output failure due to aortic or pulmonary stenosis. Do not use during pregnancy or lactation. See Section 4.7. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES 4.5 SPECIAL PRECAUTIONS FOR USE I. SPECIAL PRECAUTIONS FOR USE IN ANIMALS No evidence of renal toxicity to benazepril has been observed (in dogs or cats) during clinical trials, however, as is routine in cases of chronic kidney disease, it is recommended to monitor plasma creatinine, urea and erythrocyte counts during therapy. The efficacy and safety of benazepril has not been established in dogs and cats below 2.5 kg body weight. II. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Wash hands after use. In case of accidental oral ingestion, seek medical advice i Read the complete document