BANACEP vet 20 mg Film-coated tablets for dogs
Страна: Испания
Език: английски
Източник: HMA (Heads of Medicines Agencies)
Данни за продукта
(SPC)
30-03-2013
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Активна съставка:
benazepril 18.42 mg
Предлага се от:
Laboratorios Calier
АТС код:
QC09AA07
Лекарствена форма:
Tablet
Терапевтична група:
benazepril
Терапевтична област:
Dogs
Дата Оторизация:
2012-12-02
Данни за продукта
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT:
BANACEP vet 20 mg film-coated tablet for dogs
[BE, EL, DE, ES, IT, NL, PL, PT, UK]
BANACEP vet 20 film-coated tablet for dogs [FR]
2. QUALITATIVE AND QUANTITATIVE COMPOSITION:
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. PHARMACEUTICAL FORM:
Film-coated tablets
Beige oblong biconvex
film-coated divisible tablets. The tablets can be divided into
equal halves.
4. CLINICAL PARTICULARS:
4.1 TARGET SPECIES:
Dogs
4.2 INDICATIONS FOR USE, SPECIFYING TARGET SPECIES:
In dogs weighing more than 20 kg bw: Treatment of congestive heart failure.
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 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
4.5 SPECIAL PRECAUTIONS 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
creatinine and ur
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