Țară: Portugalia
Limbă: engleză
Sursă: HMA (Heads of Medicines Agencies)
benazepril hydrochloride 5 mg
Le Vet B.V
QC09AA07
Tablet
benazepril
Dogs Non Food
2011-07-07
PART I B 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT NL: Benazepril hydrochloride LeVet 5 mg tabletten voor honden AT: Benakor 5 mg, Tabletten für Hunde BE: Benakor F 5 mg tabletten voor honden CZ: Benakor F 5 mg, tablety pro psy EE: Benakor F 5 mg tabletid koertele ES: Benakor 5 mg comprimidos para perros FI: Benakor vet 5 mg tabletti FR: Benakor F 5 comprimés pour chiens IE: Benakor 5 mg tablets for dogs IT: Benakor 5 mg compresse per cani LU: Benakor F 5 mg comprimés pour chiens NO: Benakor vet. 5 mg tabletter til hund PL: Benakor F 5 mg tabletki dla psów PT: Benakor 5 mg comprimidos para cães SK: Benakor F 5 mg tablety pre psov 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: 4.6 mg benazepril (equivalent to 5 mg benazepril hydrochloride) EXCIPIENT(S): Colourant: Iron oxides (E172) 0.5 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Yellow oblong divisible tablets, with a break mark on one side. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dog 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Symptomatic treatment of congestive heart failure in dogs with or without adjunct therapy used in the treatment of heart failure. 4.3 CONTRAINDICATIONS Do not use in any dog that has evidence of cardiac output failure due to aortic stenosis, mitral valve stenosis or pulmonary stenosis or in case of hypotension. Do not use in case of known hypersensitivity to ACE inhibitors or to any of the ingredients of the product. See section 4.7 2 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None 4.5 SPECIAL PRECAUT Citiți documentul complet
PART I B 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT NL: Benazepril hydrochloride LeVet 5 mg tabletten voor honden AT: Benakor 5 mg, Tabletten für Hunde BE: Benakor F 5 mg tabletten voor honden CZ: Benakor F 5 mg, tablety pro psy EE: Benakor F 5 mg tabletid koertele ES: Benakor 5 mg comprimidos para perros FI: Benakor vet 5 mg tabletti FR: Benakor F 5 comprimés pour chiens IE: Benakor 5 mg tablets for dogs IT: Benakor 5 mg compresse per cani LU: Benakor F 5 mg comprimés pour chiens NO: Benakor vet. 5 mg tabletter til hund PL: Benakor F 5 mg tabletki dla psów PT: Benakor 5 mg comprimidos para cães SK: Benakor F 5 mg tablety pre psov 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: Benazepril hydrochloride 5 mg EXCIPIENT(S): Colourant: Iron oxides (E172) 0.5 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets. Yellow oblong divisible tablets, with a break mark on one side. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of congestive heart failure. 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. 2 Do not use in cases of cardiac output failure due to aortic or pulmonary stenosis. Do not use during pregnancy or lactation (section 4.7) 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS No evidence of renal toxic Citiți documentul complet