Bexepril 20 mg Film-coated tablet for dogs

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Benazepril hydrochloride

Tilgjengelig fra:

Chanelle Pharmaceuticals Manufacturing Limited

ATC-kode:

QC09AA07

INN (International Name):

Benazepril hydrochloride

Dosering :

20 mg/tablet

Legemiddelform:

Film-coated tablet

Resept typen:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk gruppe:

Dogs

Terapeutisk område:

benazepril

Indikasjoner:

Cardiovascular

Autorisasjon status:

Authorised

Autorisasjon dato:

2010-06-04

Preparatomtale

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bexepril 20mg Film-coated tablet for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each tablet contains:
Benazepril 18.42mg
(equivalent to Benazepril Hydrochloride 20mg)
EXCIPIENT:
Titanium Dioxide (E171) 3.4176mg
_ _
_ _
Iron Oxide Yellow (E172)
_ _
0.3424mg
_ _
Iron Oxide Red (E172) 0.24mg
_ _
Forthe full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
A round reddish orange biconvex tablet with a cross break line on one
side.
The tablets can be divided into equal halves or quarters.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In dogs weighing more than 40 kg:
Treatment of congestive heart failure associated with, in particular,
dilated cardiomyopathy and/or
mitral insufficiency.
4.3
CONTRAINDICATIONS
Do not use in any dog that has evidence of cardiac output failure due,
for example, to aortic stenosis.
Do not use in animals known to be hypersensitive to the active
substance or to any of the excipient(s).
See 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 the product has been observed in dogs
during clinical trials. However,
as is routine in cases of renal insufficiency, it is recommended to
monitor plasma creatinine and urea
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 and show the
label or the package leaflet to
the physician.
Pregnant women should take special care to avoid accidental oral
exposure because ACE inhibitors
have been found to affect the unborn child during pregnancy in humans.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
On rare occasions, transient signs of hypotension, such as lethargy
and ataxia may occur.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
Do not use i