BENAZEMAV FLAVOURED 5MG TABLETS FOR DOGS

Țară: Australia

Limbă: engleză

Sursă: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Ingredient activ:

BENAZEPRIL HYDROCHLORIDE

Disponibil de la:

CHANELLE PHARMACEUTICALS MANUFACTURING LIMITED

INN (nume internaţional):

benazepril HCl(5mg/Tb)

Forma farmaceutică:

ORAL TABLET

Compoziție:

BENAZEPRIL HYDROCHLORIDE UNGROUPED Active 5.0 mg/Tb

Unități în pachet:

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

Clasă:

VM - Veterinary Medicine

Produs de:

CHANELLE PHARMACEUTI

Zonă Terapeutică:

CARDIOVASCULAR SYSTEM

Rezumat produs:

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.

Statutul autorizaţiei:

Stopped

Data de autorizare:

2023-07-01

Prospect

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AUSTRALIAN GOVERNMENT
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AUSTRALIAN PESTICIDES AND
VETERINARY MEDICINES AUTHORITY
APPENDIX
2
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: 69456/106958
Signal heading;
Product name:
Active constituenVs;
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 5MG
TABLETS
FOR
DOAS
EACH
TABLET
CONTAINS
5
MG
BENAZEPRIL
HYDROCHLORIDE
For the treatment of heart failure in dogs due to mitral r
e
gurgitation (endocardiosis)
and dilated cardiomyopathy
For the treatment of chronic kidney disease in dogs
CONTENTS: 14TABLETS [28 TABLETS, 42 TABLETS, 56 TABLETS, 70 TABLETS,
84 TABLETS,
98 TABLETS, 112 TABLETS, 126 TABLETS, 10X14 TABLETS]
DIRECTIONS
FOR
USE
-
This
product
is
contraindicated
in
animals
known
to
be hypersensitive
to
benaz
epril.
This
product
is
contr
aindicated
in cases
of
hypotension,
hyponatra
emia
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
lac
tating
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
necessarily a reason to stop therapy in the absence of other signs.
It is recommended to check the hydration stat