产品特点
Veterinary Medicinal product
NELIO 5 MG TABLET FOR DOGS
PART IB
Pharmaceutical form
Tablet
Veterinary Medicinal product
NELIO 5 MG TABLET FOR DOGS
PART IB
SUMMARY OF PRODUCT CHARACTERISTICS
Pharmaceutical form
Tablet
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
NELIO 5 COMPRIME POUR CHIENS: FR
NELIO 5 MG TABLET FOR DOGS *
Nelio Vet 5 Mg Tabletti Koirille: FI
Nelio Vet 5 mg tablett för hund: SE
NELIO VET: DK
* will be translated in national language
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
EACH TABLET CONTAINS
ACTIVE SUBSTANCE:
Benazepril hydrochloride ..............................................5 mg
EXCIPIENT(S):
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
Dogs
4.2 INDICATIONS FOR USE,SPECIFYING THE TARGET SPECIES
Dogs:
- Treatment of congestive heart failure
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
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
No evidence of renal toxicity of the veterinary medicinal product has been observed during
clinical t
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