국가: 오스트레일리아
언어: 영어
출처: APVMA (Australian Pesticides and Veterinary Medicines Authority)
BENAZEPRIL HYDROCHLORIDE
DECHRA VETERINARY PRODUCTS (AUSTRALIA) PTY. LTD.
benazepril HCl(5mg/mL)
ORAL SOLUTION/SUSPENSION
BENAZEPRIL HYDROCHLORIDE UNGROUPED Active 5.0 mg/ml
15 mL; 30 mL; 50 mL
VM - Veterinary Medicine
APEX LABORATORIES
CARDIOVASCULAR SYSTEM
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.
Registered
2023-07-01
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 전체 문서 읽기
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: +61 2 4372 1661 (Business hours: 08:30 – 17:30) FAX: +61 2 4372 1668 EMAIL: thevet@apexlabs.com.au 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 전체 문서 읽기