VETACE 2.5MG TABLETS FOR DOGS AND CATS

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

BENAZEPRIL HYDROCHLORIDE

Available from:

ZOETIS AUSTRALIA PTY LTD

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 tablets; 14 tablets; 28 tablets; 42 tablets; 56 tablets; 70 tablets; 84 tablets; 98 tablets

Class:

VM - Veterinary Medicine

Therapeutic group:

CAT | DOG | BITCH | CASTRATE | CAT - QUEEN | CAT - TOM | KITTEN | PUPPY

Therapeutic area:

CARDIOVASCULAR SYSTEM

Therapeutic indications:

CHRONIC RENAL INSUFFICIENCY | CONGESTIVE HEART FAILURE | HYPERTROPHIC CARDIOMYOPATHY | DILATED CARDIOMYOPATHY | MITRAL AND/OR TRICUSPID REGUR | VALVULAR INSUFFICIENCY

Product summary:

Poison schedule: 4; Withholding period: WHP:N/A; Host/pest details: CAT: [CHRONIC RENAL INSUFFICIENCY, HYPERTROPHIC CARDIOMYOPATHY]; DOG: [CONGESTIVE HEART FAILURE]; Poison schedule: 4; Host/pest details: CAT: [CHRONIC RENAL INSUFFICIENCY, HYPERTROPHIC CARDIOMYOPATHY]; DOG: [CONGESTIVE HEART FAILURE]; Poison schedule: 4; Withholding period: ; Host/pest details: CAT: [CHRONIC RENAL INSUFFICIENCY, HYPERTROPHIC CARDIOMYOPATHY]; DOG: [CONGESTIVE HEART FAILURE]; For the treatment of heart failure in dogs due to mitral regurgitation (endocardiosis) and dilated cardiomyopathy. For the treatment of hypertrophic cardiomyopathy in cats. For the treatment of chronic renal insufficiency in cats.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

For Official Use Only
E-LABEL APPLICATION (DRAFT)
COMPANY NAME:
JUROX PTY LIMITED
PRODUCT NAME:
VETACE 2.5MG TABLETS FOR DOGS AND CATS
ELABEL APPLICATION NO:
DC14-45642560E8
APVMA APPROVAL NO:
61589/100848
PRODUCT NO:
61589
VERSION NO:
4.0
APPLICATION STARTED:
2014-Sep-15 14:53:22
VERSION CREATED:
2015-Jul-31 10:25:46
STARTED BY:
Caroline Feilen
PRINTED:
2015-Jul-31 10:31:51
LABEL NAME:
VETACE 2.5MG TABLETS FOR DOGS AND CATS
SIGNAL HEADINGS:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
CONSTITUENT
STATEMENTS:
Each tablet contains 2.5 mg BENAZEPRIL HYDROCHLORIDE
CLAIMS:
For use by or under direction of a registered veterinarian.
For the treatment of heart failure in dogs due to mitral regurgitation
(endocardiosis) and
dilated cardiomyopathy.
For the treatment of hypertrophic cardiomyopathy in cats.
For the treatment of chronic renal insufficiency in cats.
NET CONTENTS:
14 tablets
28 tablets
42 tablets
56 tablets
70 tablets
84 tablets
98 tablets
112 tablets
DIRECTIONS FOR USE:
Use as directed by prescribing veterinarian.
DIRECTIONS FOR USE:
READ THE ATTACHED LEAFLET BEFORE USING THIS PRODUCT
RESTRAINTS:
CONTRAINDICATIONS:
PRECAUTIONS:
Dogs RLP APPROVED
For Official Use Only
Use during pregnancy and lactation: The safety of benazepril HCl has
not been tested
in breeding dogs. VetACE is therefore not recommended for use in
pregnant or lactating
bitches. No data are available in lactating bitches.
In double blind clinical trials, benazepril HCl was well tolerated
with an incidence of adverse
effects statistically lower than observed in placebo treated dogs. A
small number of dogs
may exhibit transient signs of fatigue.
Clinical trials have shown benazepril HCl to have good renal
tolerance. Plasma urea and
creatinine concentrations did not change and no evidence of renal
toxicity of benazepril HCl
has been observed in dogs during clinical trials. The biliary
excretion of benazeprilat means
that there is little risk of bioaccumulation in dogs and cats with
impaired renal function.
H

Summary of Product characteristics

VETACE TABLETS
Page 1 of 4
ISSUED:
12 APRIL 2010
MATERIAL SAFETY DATA SHEET
SECTION 1: IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
PRODUCT NAME:
VETACE 2.5 MG TABLETS FOR DOGS AND CATS
VETACE 5 MG TABLETS FOR DOGS AND CATS
VETACE 20 MG TABLETS FOR DOGS
PRODUCT CODE:
504045 (2.5 mg); 504060 (5 mg); 504055 (20 mg)
RECOMMENDED USE:
For the treatment of heart failure in dogs due to mitral regurgitation
(endocardiosis) and dilated cardiomyopathy, and both chronic renal
insufficiency and hypertrophic cardiomyopathy in cats.
COMPANY IDENTIFICATION:
Jurox Pty Limited
ADDRESS:
85 Gardiner Road
Rutherford NSW 2320
Australia
CUSTOMER CENTRE:
1800 023 312
NATIONAL POISONS INFORMATION CENTRE:
131126 (Australia-wide)
EMERGENCY TELEPHONE NUMBER:
1800 023 312
SECTION 2: HAZARDS IDENTIFICATION
HAZARD CLASSIFICATIONS:
NOT CONSIDERED A HAZARDOUS SUBSTANCE ACCORDING TO THE CRITERIA OF
NOHSC
AUSTRALIA.
NOT CONSIDERED A DANGEROUS GOOD ACCORDING TO THE CRITERIA OF THE
AUSTRALIAN
DANGEROUS GOODS (ADG) CODE.
POISONS SCHEDULE:
S4
RISK PHRASES:
None
SAFETY PHRASES:
None
SECTION 3: COMPOSITION / INFORMATION ON INGREDIENTS
VETACE 2.5 MG AND 5 MG TABLETS FOR DOGS AND CATS
INGREDIENT
CAS NO.
CONTENT
Benazepril Hydrochloride
86541-74-4
2.6%
Other non-hazardous ingredients
97.4%
VETACE 20 MG TABLETS FOR DOGS
INGREDIENT
CAS NO.
CONTENT
Benazepril Hydochloride
86541-74-4
10.4%
Other non-hazardous ingredients
89.6%
VETACE TABLETS
Page 2 of 4
SECTION 4: FIRST AID MEASURES
FIRST AID MEASURES:
Consult the National Poisons Centre on 131126 or a doctor immediately
in every case of
suspected chemical poisoning. Never give fluids or induce vomiting if
a patient is unconscious
or convulsing regardless of cause of injury. If medical
advice/attention is needed, have product
container or label at hand.
INHALATION:
Remove patient to fresh air. Lay patient down and keep warm and
rested. If breathing is
shallow or has stopped, ensure airway is clear and apply
resuscitation. If breathing is difficult,
give oxygen. Seek medical assistance immediately.
INGESTION

Safety Data Sheet

WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Ltd
TECHNICAL NOTES
ACTIVE CONSTITUENTS
Benazepril hydrochloride 2.5, 5, 20 mg/tablet.
ACTIONS
PHARMACOLOGY
Benazepril hydrochloride is a prodrug which is hydrolysed _in vivo_ to
benazeprilat, which inhibits the angiotensin converting enzyme
(ACE), thus preventing the conversion of inactive angiotensin I into
active angiotensin II. Benazepril hydrochloride reduces all effects
mediated by angiotensin II, including vasoconstriction of both
arteries and veins and retention of sodium and water by the kidney.
It causes long lasting inhibition of plasma ACE in dogs and cats, with
significant inhibition persisting for 24 hours after a single dose.
ACE inhibitors may increase blood potassium levels, which may be
beneficial when hypokalaemia associated with chronic renal
insufficiency in cats occurs.
PHARMACOKINETICS
Benazepril hydrochloride is rapidly but incompletely absorbed from the
gastrointestinal tract following oral administration. Absorbed
benazepril is partially hydrolysed by hepatic enzymes to the active
substance, benazeprilat; unchanged benazepril and hydrophilic
metabolites account for the remainder. Peak plasma benazeprilat
concentrations are attained within about two hours both in fasting
and fed situations. Benazepril and benazeprilat are bound to plasma
proteins, and in tissues are found mainly in the liver and kidney.
The major part of benazeprilat is rapidly eliminated, although there
is in addition a slow terminal elimination phase. Benazeprilat
is excreted approximately equally via both biliary and urinary routes
in dogs, and primarily via the biliary route in cats. Repeated
administration of benazepril hydrochloride leads to slight
accumulation of benazeprilat in plasma, and steady state is attained
within
four days. As it is excreted via the biliary route, there is little
risk of bioaccumulation of benazeprilat in dogs or cats with impaired
renal
function. For this reason, no dose adjustment of the product is
necess