国家: 澳大利亚
语言: 英文
来源: APVMA (Australian Pesticides and Veterinary Medicines Authority)
PIMOBENDAN
Eurovet Animal Health BV
pimobendan(1.25mg/Tb)
ORAL BOLUS, CHEWABLE
PIMOBENDAN PYRIDAZINONE Active 1.25 mg/Tb
100 Tablets; 20 Tablets; 250 Tablets; 40 Tablets; 50 Tablets; 80 Tablets
VM - Veterinary Medicine
CARDIOVASCULAR SYSTEM
Poison schedule: 4; Withholding period: ; Host/pest details: DOG: [CONGESTIVE HEART FAILURE]; DOG - LARGE: [PRECLINICAL DCM]; Poison schedule: 4; Withholding period: ; Host/pest details: DOG: [CONGESTIVE HEART FAILURE]; For the treatment of canine congestive heart failure originating from valvular insufficiency (mitral and/or tricuspid regurgitation) or dilated cardiomyopathy.See Contraindications, Precautions & Side Effects on label
Registered
2023-07-01
CARDISURE FLAVOURED 1.25MG TABLETS FOR DOGS 81948/104469 Product Name: APVMA Approval No: Label Name: CARDISURE FLAVOURED 1.25MG TABLETS FOR DOGS Signal Headings: PRESCRIPTION ANIMAL REMEDY KEEP OUT OF REACH OF CHILDREN FOR ANIMAL TREATMENT ONLY Constituent Statements: Each tablet contains 1.25 mg pimobendan. Claims: For the treatment of canine congestive heart failure originating from valvular insufficiency (mitral and/or tricuspid regurgitation) or dilated cardiomyopathy. Net Contents: 20, 50, 100 or 250 tablets Directions for Use: Restraints: Contraindications: This product is contraindicated in cases of hypertrophic cardiomyopathies or clinical conditions where an augmentation of cardiac output is not recommended for functional or anatomical reasons (e.g. aortic stenosis). Precautions: CARDISURE FLAVOURED TABLETS should only be administered to pregnant and lactating bitches if the expected therapeutic benefits outweigh the potential risk. Studies into the effect of pimobendan on the reproductive function of male dogs have not been conducted. The use in dogs not showing signs of cardiac disease is not recommended. In pharmacological studies no interaction between the cardiac glycoside ouabain and pimobendan was detected. The pimobendan induced increase in contractility of the heart is attenuated in the presence of the calcium antagonist verapamil and the B-antagonist propranolol. RLP APPROVED Side Effects: A moderate positive chronotropic effect and vomiting may occur in rare cases. However, these effects are dose-dependent and can be avoided by reducing the dose in those cases. In rare cases transient diarrhoea, anorexia or lethargy have been observed. Dosage and Administration: The tablets should be administered orally at a dose range of 0.2 mg to 0.6 mg pimobendan/ kg body weight per day. The preferable daily dose is 0.5 mg pimobendan/kg body weight. The dose should be divided into two administrations (0.25 mg/kg body weight), one half dose in the morning and the other half approximately 12 hours later. The 阅读完整的文件
Safety Data Sheet Product Name: Cardisure ® Flavoured tablets Issue Date: 03/2018 Version No: 1 Page 1 of 11 SECTION 1: IDENTIFICATION 1.1 PRODUCT IDENTIFIER PRODUCT NAME: Cardisure ® Flavoured Tablets (containing 1.25mg, 2.5mg, 5mg or 10mg pimobendan) SYNONYMS: Pimocard, Pimosure 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 canine congestive heart failure originating from valvular insufficiency (mitral and/or tricuspid regurgitation) or dilated cardiomyopathy. 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: 1300 015 825 (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 GHS CLASSIFICATION(S): Specific target organ toxicity - single exposure - Category 3 (respiratory tract irritation) Please note that respiratory irritation is unlikely to occur due to physical form of the product and how it is packaged 2.2 LABEL ELEMENTS SIGNAL WORD: WARNING Safety Data Sheet Product Name: Cardisure ® Flavoured tablets Issue Date: 03/2018 Version No: 1 Page 2 of 11 HAZARD STATEMENT(S): H335 May cause respiratory irritation PRECAUTIONARY STATEMENT(S) PREVENTION: P261 Avoid breathing dust/fumes. PRECAUTIONARY STATEMENT(S) RESPONSE: P312 Call a POISON CENTER or doctor/physician if you feel unwell. P304+P340 IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing. PRECAUTIONARY STATEMENT(S) STORAGE: P405 Store locked up. PRECAUTIONARY STATEMENT(S) DISPOSAL: P501 Dispose of contents/container in accordance with local regulations. 2.3 OTHER HAZARD I 阅读完整的文件