BENAZEMAV FLAVOURED 20MG TABLETS FOR DOGS

País: Austràlia

Idioma: anglès

Font: APVMA (Australian Pesticides and Veterinary Medicines Authority)

ingredients actius:

BENAZEPRIL HYDROCHLORIDE

Disponible des:

CHANELLE PHARMACEUTICALS MANUFACTURING LIMITED

Designació comuna internacional (DCI):

benazepril HCl(20mg/Tb)

formulario farmacéutico:

ORAL TABLET

Composición:

BENAZEPRIL HYDROCHLORIDE UNGROUPED Active 20.0 mg/Tb

Unidades en paquete:

10x14tabs; 112; 126; 14; 28; 42; 56; 70; 84; 98

clase:

VM - Veterinary Medicine

Fabricat per:

CHANELLE PHARMACEUTI

Área terapéutica:

CARDIOVASCULAR SYSTEM

Resumen del producto:

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.

Estat d'Autorització:

Registered

Data d'autorització:

2023-07-01

Informació per a l'usuari

APPENDIX2
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AUSTRALIAN GOVERNMENT
AUSTRALIAN PESTICIDES AND
VETERINARY MEDICINES AUTHORITY
TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPS)
_(VETERINARY PRODUCTS) _
_Select appropriate: _
XD New Product (include all applicable RLPs)
OR
D Variation (highlight instructions that are being varied). Approval
no. of label being varied:
Signal heading:
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 20MG
TABLETS FOR DOGS
EACH TABLET CONTAINS 20MG 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]
DIREC
T
IONS FOR USE
"
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.
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 o r
lactating bitches. No data are available in lactating bitches. ACE
inhibitors have been
found 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
necessaril
y
a reason to stop therapy in the absence of other signs.
It is recommended to check the hydration status of the patien