Страна: Австралия
Язык: английский
Источник: APVMA (Australian Pesticides and Veterinary Medicines Authority)
BENAZEPRIL HYDROCHLORIDE
CHANELLE PHARMACEUTICALS MANUFACTURING LIMITED
benazepril HCl(5mg/Tb)
ORAL TABLET
BENAZEPRIL HYDROCHLORIDE UNGROUPED Active 5.0 mg/Tb
112; 126; 14; 140; 28; 42; 56; 70; 84; 98
VM - Veterinary Medicine
CHANELLE PHARMACEUTI
CARDIOVASCULAR SYSTEM
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.
Stopped
2023-07-01
.'! .� AUSTRALIAN GOVERNMENT � 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 Прочитать полный документ