Nazione: Grecia
Lingua: inglese
Fonte: HMA (Heads of Medicines Agencies)
benazepril hydrochloride 4.6 mg
Laboratorios Calier
QC09AA07
Tablet
benazepril
Cats, Dogs
2012-12-02
PART I.B.2. PROPOSAL FOR INMEDIATE AND PACKAGE LEAFLET PACKAGE LEAFLET 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder and manufacturer Laboratorios Calier, S.A. Barcelonès, 26 (Pla del Ramassà) Les Franqueses del Vallès (Barcelona) SPAIN 2. NAME OF THE VETERINARY MEDICINAL PRODUCT BANACEP ® vet 5 mg film-coated tablet for dogs and cats (BE,DK,DE,EL,ES,FI,IT,NL,PL,PT,SW,UK) Benazepril hydrochloride BANACEP ® vet 5 film-coated tablet for dogs and cats [FR] 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) 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 4. INDICATION(S) Banacep vet 5 mg or 5 _ _belongs to a group of medicines called Angiotensin Converting Enzyme (ACE) inhibitors. It is prescribed by the veterinary surgeon for the treatment of congestive heart failure in dogs and for reduction of proteinuria associated with chronic kidney disease in cats. 5. CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substance benazepril hydrochloride or to any ingredient of the tablets. Do not use in cases of hypotension (low blood pr Leggi il documento completo
12462 BANACEP 5 renewal D90 SPC D81 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT: BANACEP vet 5 mg film-coated tablet for dogs and cats (BE,DK,DE,EL,ES,FI,IT,NL, PL,PT,SW,UK) Benazepril hydrochloride BANACEP vet 5 film-coated tablet for dogs and cats [FR] 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: 4.1 TARGET SPECIES: Dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING TARGET SPECIES: Dogs: Treatment of congestive heart failure. Cats: Reduction of proteinuria associated with chronic kidney disease. 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. 12462 BANACEP 5 renewal D90 SPC D81 Do not use in cases of cardiac output failure due to aortic or pulmonary stenosis. Do not use in pregnancy or lactation (see section 4.7). 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None 4.5 S Leggi il documento completo