Страна: Португалія
мова: англійська
Джерело: HMA (Heads of Medicines Agencies)
benazepril hydrochloride 4.6 mg
CHEMO IBERICA SA
QC09AA07
Tablet
benazepril
Cats, Dogs
2012-12-02
PACKAGE LEAFLET PRILBEN ® vet 5 film-coated tablet for dogs and cats [FR] PRILBEN vet 5 mg film-coated tablet for dogs and cats Benazepril hydrochloride [DE/PL] Prilben vet 5 mg film-coated tablet for dogs and cats Benazepril hydrochloride [SE] PRILBEN ® vet 5 mg film-coated tablet for dogs and cats Benazepril hydrochloride [BE/DK/EL/ES/FI/IT/NL/PT/UK] 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder Chemo Ibérica, S.A. Gran Vía Carlos III, 98 – 7ª 08028 Barcelona SPAIN Manufacturer for the batch release Laboratorios LICONSA, S.A Avda. Miralcampo, 7, Pol. Ind. Miralcampo Azuqueca de Henares, 19200 Guadalajara SPAIN 2. NAME OF THE VETERINARY MEDICINAL PRODUCT PRILBEN ® vet 5 film-coated tablet for dogs and cats [FR] PRILBEN vet 5 mg film-coated tablet for dogs and cats [PL] PRILBEN vet 5 mg film-coated tablet for dogs and cats Benazepril hydrochloride [DE] Prilben vet 5 mg film-coated tablet for dogs and cats Benazepril hydrochloride [SE] PRILBEN ® vet 5 mg film-coated tablet for dogs and cats Benazepril hydrochloride [BE/DK/EL/ES/FI/IT/NL/PT/UK] 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 Прочитайте повний документ
12463 PRILBEN 5 renewal SPC D90D81 S) SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT: PRILBEN vet 5 film-coated tablet for dogs and cats [FR] PRILBEN vet 5 mg film-coated tablet for dogs and cats [PL] PRILBEN vet 5 mg film-coated tablet for dogs and cats Benazepril hydrochloride [DE] Prilben vet 5 mg film-coated tablet for dogs and cats Benazepril hydrochloride [SE] PRILBEN vet 5 mg film-coated tablet for dogs and cats Benazepril hydrochloride [BE/DK/EL/ES/FI/IT/NL/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 TabletBeige 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. 12463 PRILBEN 5 renewal SPC D90D81 S) Do not use in cases of hypotension, hypovolaemia, hyponatraemia or acute renal failure. Do not use in cases of cardiac o Прочитайте повний документ