BENAZEMAV FLAVOURED 2.5MG TABLETS FOR DOGS

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

BENAZEPRIL HYDROCHLORIDE

Available from:

CHANELLE PHARMACEUTICALS MANUFACTURING LIMITED

INN (International Name):

benazepril HCl(2.5mg/Tb)

Pharmaceutical form:

ORAL TABLET

Composition:

BENAZEPRIL HYDROCHLORIDE UNGROUPED Active 2.5 mg/Tb

Units in package:

112; 126; 14; 140; 28; 42; 56; 70; 84; 98

Class:

VM - Veterinary Medicine

Manufactured by:

CHANELLE PHARMACEUTI

Therapeutic area:

CARDIOVASCULAR SYSTEM

Product summary:

Poison schedule: 4; Withholding period: WITHHOLDING PERIOD: N/A; Host/pest details: DOG: [CARDIAC FAILURE, CHRONIC KIDNEY DISEASE, CONGESTIVE HEART FAILURE]; For the treatment of heart failure in dogs due to mitral regurgitation (endocardiosis) and dilated cardiomyopathy. For the treatment of chronic kidney disease in dogs.This product is contraindicated in animals known to be hypersensitive to benazepril. This product is contraindicated in cases of hypotension, hyponatraemia or acute renal failure.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

•*
APPENDIX 2
AUSTRALIAN GOVERNMENT
AUSTRALIAN PESTICIDES AND
VETERINARY MEDICINES AUTHORITY
TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPS)
_(VETERINARY PRODUCTS) _
_Select appropriate: _
A
New Product (include all applicable RLPs)
OR
X
A
Variation (highlight instructions that are being varied). Approval no.
of label being varied:
Signal head
i
ng:
Product name:
Active constituent/s:
STATEMENT OF CLAIMS:
Net contents:
DIRECTIONS FOR USE
Heading:
Restraints:
CONTRAINDICATIONS:
PRECAUTIONS:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
BEXEPRIL FLAVOURED 2.5
MG
TABLETS FOR DOAS
EACH TABLET CONTAINS 2.5MG BENAZEPRIL HYDROCHLORIDE
For the treatment of heart failure in dogs due to mitral regurgitation
(endocardiosis)
and dilated cardiomyopathy
For the treatment of chronic kidney disease in dogs
CONTENTS: 14 TABLETS [28 TABLETS, 42 TABLETS, 56 TABLETS, 70 TABLETS,
84 TABLETS,
98 TABLETS, 112 TABLETS, 126 TABLETS, 10X14 TABLETS]
DIRECTIONS FOR USE
-
This
product
is
ontraindicated in
animals
known
to
be
hypersensitive
to
benazepril.
This
product
is
contraindicated in cases of
hypotension,
hyponatraemia or acute renal
failure.
Use during pregnancy and lactation: The safety of
BEXEPRIL has not been tested in
breeding dogs. BEXEPRIL is therefore not recommended for use in
pregnant or
lactating bitches. No data are available in lactating bitches. ACE
inhibitors have been
f
ound to be teratogenic in the second and third trimesters in other
species.
The efficacy and safety of BEXEPRIL have not been established in dogs
below 2.5 kg
bodyweight.
In dogs with chronic kidney disease,
BEXEPRIL may increase plasma creatinine
concentrations at the start of therapy. A moderate increase in plasma
creatinine
concentrations following administration of ACE inhibitors is
compatible with the
reduction in glomerular hypertension induced by these agents, and is
therefore not
necessarily a reason to stop therapy in the absence of other signs.
It is recommended to check the hydration status of the patient b