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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAM E OF THE VETERINARY M EDICINAL PRODUCT:
PRILBEN vet 20 film-coated tablet for dogs [FR]
PRILBEN vet 20 mg film-coated tablet for dogs [PL]
Prilben vet 20 mg film-coated tablet for dogs [SE]
PRILBEN vet 20 mg film-coated tablet for dogs
[DE/BE/DK/EL/ES/FI/IT/NL/PT/UK]
2. QUALITATIVE AND QUANTITATIVE COM POSITION:
Each divisible tablet contains:
ACTIVE SUBSTANCE:
Benazepril ................................. 18.42 mg
(equivalent to Benazepril Hydrochloride 20 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. PHARM ACEUTICAL FORM :
Film-coated tablets. The tablets can be divided into equal halves.
Beige oblong biconvex
film-coated divisible tablets
4. CLINICAL PARTICULARS:
4.1 TARGE T SPE CIE S:
Dogs
4.2 INDICATIONS FOR USE, SPECIFYING TARGET SPECIES:
In dogs weighing more than 20 kg bw: Treatment of congestive heart failure.
FORMATIERT: Englisch (USA )
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4.3 . CONTRAINDICATIONS:
Do not use in cases of known hypersensitivity to ACE inhibitors or to any ingredient
of the product.
Do not use in any dog that has evidence of cardiac output failure, for example, due to
aortic stenosis.
See also section 4.7
4.4 SPE CIAL WARNINGS FOR E ACH TARGE T SPE CIE S
None
4.5 SPE CIAL PRE CAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
No evidence of renal toxicity to benazepril has been observed in dogs. However, as
is routine in cases of chronic renal insufficiency, it is recommended to monitor plasma
creatinin
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