BEXEPRIL 2.5 MG FILM-COATED TABLET FOR DOGS
Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Vara einkenni
(SPC)
13-10-2016
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Virkt innihaldsefni:
BENAZEPRIL (AS HYDROCHLORIDE) EQUIVALENT TO BENAZEPRIL HYDROCHLORIDE PH.EUR.
Fáanlegur frá:
Chanelle Pharmaceuticals Manufacturing Limited
ATC númer:
QC09AA07
INN (Alþjóðlegt nafn):
BENAZEPRIL (AS HYDROCHLORIDE) EQUIVALENT TO BENAZEPRIL HYDROCHLORIDE PH.EUR.
Skammtar:
2.5 mg/tablet
Lyfjaform:
Film Coated Tablet
Gerð lyfseðils:
POM
Meðferðarhópur:
Canine
Lækningarsvæði:
Benazepril
Ábendingar:
Cardiovascular
Leyfisstaða:
Authorised
Leyfisdagur:
2010-06-04
Vara einkenni
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Bexepril 2.5 mg Film-coated tablet for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each tablet contains:
Benazepril
2.3 mg
(equivalent to Benazepril Hydrochloride 2.5 mg)
EXCIPIENT:
Titanium Dioxide (E171)
0.5 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
A white round biconvex tablet with break line on one side. The tablets can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In dogs weighing more than 5 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.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 28/09/2016_
_CRN 7024622_
_page number: 1_
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 wome
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