Nelio 5 mg Tablet for Dogs

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Benazepril

Dostopno od:

Ceva Santé Animale

Koda artikla:

QC09AA07

INN (mednarodno ime):

Benazepril

Odmerek:

5 mg/tablet

Farmacevtska oblika:

Tablet

Tip zastaranja:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapevtska skupina:

Dogs

Terapevtsko območje:

benazepril

Terapevtske indikacije:

Cardiovascular

Status dovoljenje:

Authorised

Datum dovoljenje:

2009-09-25

Lastnosti izdelka

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nelio 5 mg Tablet for Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
EACH TABLET CONTAINS
ACTIVE SUBSTANCE:
Benazepril hydrochloride ........................................... 5
mg
EXCIPIENT(S):
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
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 trials, however, as is routine in cases of chronic kidney
disease, it is recommended to
monitor plasma creatinine, urea and erythrocyte counts during therapy.
The safety and efficacy of the product has not been examined in dogs
weighing less than 2.5
kg.
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 double-blind clinical trials in dogs with congestive heart failure,
the product_ _was well
tolerated with an incidence of adverse reactions lower than observed
in placebo-treated
d