产品特点
Veterinary Medicinal product
NELIO 5 mg TABLET FOR CATS
PART IB
Pharmaceutical form
Tablet
Veterinary Medicinal product
NELIO 5 mg TABLET FOR CATS
PART IB
SUMMARY OF PRODUCT CHARACTERISTICS
Pharmaceutical form
Tablet
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
NELIO 5 mg TABLET FOR CATS
FR : NELIO 5 TABLET FOR CATS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
EACH TABLET CONTAINS
ACTIVE SUBSTANCE:
Benazepril hydrochloride .................................... 5 mg
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Clover shaped scored beige tablet, divisible into halves or quarters.
4.
CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cats.
4.2 INDICATIONS FOR USE,SPECIFYING THE TARGET SPECIES
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.
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
I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Efficacy and safety of benazepril have not been established in cats of weight less than 2.5 kg
No evidence of renal toxicity to the veterinary medicinal product has been observed in cats
during clinical trials,
however, as is routine in cases of chronic ki
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