Nelio 5 mg tablet for cats

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Benazepril hydrochloride

Tersedia dari:

Ceva Santé Animale

Kode ATC:

QC09AA07

INN (Nama Internasional):

Benazepril hydrochloride

Dosis:

5 mg/tablet

Bentuk farmasi:

Tablet

Jenis Resep:

POM: Prescription Only Medicine as defined in relevant national legislation

Kelompok Terapi:

Cats

Area terapi:

benazepril

Indikasi Terapi:

Cardiovascular

Status otorisasi:

Authorised

Tanggal Otorisasi:

2016-06-03

Karakteristik produk

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
NELIO 5 mg TABLET FOR CATS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
EACH TABLET CONTAINS
ACTIVE SUBSTANCE:
Benazepril hydrochloride .................................. 5 mg
EXCIPIENTS:
For the 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
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
kidney disease, it is
recommended to monitor plasma creatinine, urea and erythrocyte counts
during therapy.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL
PRODUCT TO ANIMALS
Wash hands after use.
In case of accidental oral ingestion, seek medical advice immediately
and show the label or
the package leaflet to the physician.
Pregnant women should take special care to avoid accidental oral
exposure, because
angiotensin converting enzyme (ACE) inhibitors have been found to
affect the unborn child
during pregnancy in humans.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
In cats with chronic kidney disease, the product may increase plasma
creatinine
concentrations at the start of therapy. A moderate increase in plasma
creatinine