Benakor Oral Solution

Țară: Australia

Limbă: engleză

Sursă: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Ingredient activ:

BENAZEPRIL HYDROCHLORIDE

Disponibil de la:

DECHRA VETERINARY PRODUCTS (AUSTRALIA) PTY. LTD.

INN (nume internaţional):

benazepril HCl(5mg/mL)

Forma farmaceutică:

ORAL SOLUTION/SUSPENSION

Compoziție:

BENAZEPRIL HYDROCHLORIDE UNGROUPED Active 5.0 mg/ml

Unități în pachet:

15 mL; 30 mL; 50 mL

Clasă:

VM - Veterinary Medicine

Produs de:

APEX LABORATORIES

Zonă Terapeutică:

CARDIOVASCULAR SYSTEM

Rezumat produs:

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

Statutul autorizaţiei:

Registered

Data de autorizare:

2023-07-01

Prospect

Company Name:
Product Name:
APVMA Approval No:
APEX LABORATORIES PTY LTD
Apex Benazepril Oral Solution
80867/101844
Label Name:
Apex Benazepril Oral Solution
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
READ SAFETY DIRECTIONS
Constituent
Statements:
5 mg/mL BENAZEPRIL HYDROCHLORIDE
Claims:
For the treatment of heart failure due to mitral regurgitation
(endocardiosis) and dilated
cardiomyopathy. For the treatment of chronic kidney disease in dogs.
Net Contents:
50 mL
Directions for Use:
Restraints:
Contraindications:
This product is contraindicated for use in animals known to be
sensitive to benazepril. This
product is contraindicated for use in dogs with hypotension,
hypovolaemia, hyponatraemia
or acute renal failure.
Precautions:
The safety of Apex Benazepril Oral Solution has not been established
in breeding animals.
Use is therefore not recommended in pregnant or lactating bitches. ACE
inhibitors have
been found to be teratogenic in the second and third trimesters in
other species. The
efficacy and safety of Apex Benazepril Oral Solution has not been
established in dogs
under 2.5kg bodyweight.
In dogs with chronic renal disease benazepril 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 RLP APPROVED
hydration status of the patient before starting treatment with
benazepril and to monitor
plasma creatinine and blood erythrocyte counts during therapy.
In double blind clinical trials, benazepril hydrochloride was well
tolerated with an incidence
of adverse effects statistically lower than observed in placebo
treated dogs. A small number
of dogs may exhibit vomiting or transient signs of fatigue.
Interactions with potassium sparing drugs lik

Caracteristicilor produsului

Safety Data Sheet
Product Name: Benazepril Oral Solution 50ml
Issue Date: 09/2017
Version No: 1
Page 1 of 12
SECTION 1: IDENTIFICATION
1.1 PRODUCT IDENTIFIER
PRODUCT NAME:
Benazepril Oral Solution 50ml
SYNONYMS:
Not Available
PROPER SHIPPING NAME:
Not Available
OTHER MEANS OF
IDENTIFICATION:
None
1.2 RELEVANT IDENTIFIED USES OF THE SUBSTANCES OR MIXTURE AND USES
ADVISED AGAINST
RECOMMENDED USES:
For the treatment of heart failure due to mitral regurgitation
(endocardiosis) and dilated cardiomyopathy.
For the treatment of chronic kidney disease in dogs.
USES ADVISED AGAINST:
Not for human use.
1.3 DETAILS OF THE SUPPLIER OF THE SUBSTANCE OR MIXTURE
REGISTERED COMPANY
NAME:
Apex Laboratories Pty Ltd
ADDRESS:
Apex Laboratories Pty Ltd
ACN 614 716 700
2 Cal Close
Somersby NSW 2250
TELEPHONE:
[phone] (Business hours: 08:30 – 17:30)
FAX:
[phone]
EMAIL:
[e-mail]
WEBSITE:
www.apexlabs.com.au
1.4 EMERGENCY TELEPHONE NUMBERS
13 11 26 (Poisons Information Centre)
SECTION 2: HAZARDS IDENTIFICATION
2.1 CLASSIFICATION OF THE SUBSTANCE OR MIXTURE
Not Applicable
2.2 LABEL ELEMENTS
SIGNAL WORD:
Not Applicable
HAZARD STATEMENT(S)
Not Applicable
ADDITIONAL STATEMENT(S)
Safety Data Sheet
Product Name: Benazepril Oral Solution 50ml
Issue Date: 09/2017
Version No: 1
Page 2 of 12
Not Applicable
PRECAUTIONARY STATEMENT(S) PREVENTION:
Not Applicable
PRECAUTIONARY STATEMENT(S) RESPONSE:
Not Applicable
PRECAUTIONARY STATEMENT(S) STORAGE:
Not Applicable
PRECAUTIONARY STATEMENT(S) DISPOSAL:
Not Applicable
2.3 OTHER HAZARD INFORMATION
N/a
SECTION 3: INFORMATION ON THE INGREDIENTS
3.1 SUBSTANCES
See section below for composition of mixtures
3.2 MIXTURES
INGREDIENT
CAS NO
EC NUMBER
CONTENT
Benazepril
Hydrochloride
86541-74-4
Not Available
0.5%
Other non-hazardous
ingredients
N/a
N/a
N/a
SECTION 4: FIRST AID MEASURES
4.1 DESCRIPTION OF FIRST AID MEASURES
EYE CONTACT:
In case of accidental contact of the product with the eyes rinse
abundantly with fresh water, removing any contact lenses. Seek
medical attention if