Bexepril 2.5mg Film-coated Tablet for Dogs

Страна: Великобритания

Език: английски

Източник: VMD (Veterinary Medicines Directorate)

Активна съставка:

Benazepril Hydrochloride

Предлага се от:

Chanelle Pharmaceuticals Manufacturing Ltd

АТС код:

QC09AA07

INN (Международно Name):

Benazepril Hydrochloride

Лекарствена форма:

Film-coated tablet

Вид предписание :

POM-V - Prescription Only Medicine – Veterinarian

Терапевтична група:

Dogs

Терапевтична област:

Cardio Vascular ACE inhibitor

Статус Оторизация:

Expired

Дата Оторизация:

2010-04-23

Данни за продукта

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