Bexepril 2.5mg Film-coated Tablet for Dogs

Nazione: Regno Unito

Lingua: inglese

Fonte: VMD (Veterinary Medicines Directorate)

Principio attivo:

Benazepril Hydrochloride

Commercializzato da:

Chanelle Pharmaceuticals Manufacturing Ltd

Codice ATC:

QC09AA07

INN (Nome Internazionale):

Benazepril Hydrochloride

Forma farmaceutica:

Film-coated tablet

Tipo di ricetta:

POM-V - Prescription Only Medicine – Veterinarian

Gruppo terapeutico:

Dogs

Area terapeutica:

Cardio Vascular ACE inhibitor

Stato dell'autorizzazione:

Expired

Data dell'autorizzazione:

2010-04-23

Scheda tecnica

Revised: June 2015
AN: 01654/2014
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bexepril 2.5mg Film-coated tablet for dogs (BE & IE)
Bexepril 2.5mg Film-coated tablet for dogs (BG, CY, CZ, DK, EL, ES,
HU, LU, NL, NO,
PT, RO, SI, SK & UK)
Sirdis 2.5mg Film-coated tablet for dogs (IT)
Bexepril 2.5mg Film-coated tablets for dogs (PL)
Bexepril 2.5 Film-coated tablet for dogs (FR)
Bexepril 2.5mg Film-coated tablets for dogs, Benazeprilhydochlorid
(AT)
Benadog Flavour 2.5mg Film-coated tablets for dogs,
Benazeprilhydochlorid (DE)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each tablet contains:
Benazepril 2.3mg
(equivalent to Benazepril Hydrochloride 2.5 mg)
EXCIPIENT:
Titanium Dioxide (E171) 0.5mg
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.
Revised: June 2015
AN: 01654/2014
Page 2 of 5
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