Land: Australia
Språk: engelsk
Kilde: APVMA (Australian Pesticides and Veterinary Medicines Authority)
ALPHAXALONE
ZOETIS AUSTRALIA PTY LTD
PARENTERAL LIQUID/SOLUTION/SUSPENSION
ALPHAXALONE ANAESTHETIC Active 10.0 mg/ml
10mL; 20ml
VM - Veterinary Medicine
ANAESTHETICS/ANALGESICS
Poison schedule: 4; Withholding period: ; Host/pest details: CAT: [ANAESTHETIC - LOCAL/GENERAL]; DOG: [ANAESTHETIC - LOCAL/GENERAL]
Registered
2023-07-01
Product Name: APVMA Approval No: Alfaxan Multidose Anaesthetic Injection 83248/114856 Label Name: Alfaxan Multidose Anaesthetic Injection Signal Headings: PRESCRIPTION ANIMAL REMEDY KEEP OUT OF REACH OF CHILDREN FOR ANIMAL TREATMENT ONLY Constituent Statements: 10 mg/mL alfaxalone Claims: As an induction agent prior to gaseous anaesthesia, or As a sole anaesthetic agent for the induction and maintenance of anaesthesia for the performance of examination or surgical procedures. Net Contents: 10 mL, 20 mL Directions for Use: Restraints: Contraindications: Alfaxan Multidose is contraindicated for use in combination with other intravenous anaesthetic agents. Precautions: Alfaxan Multidose should be given by slow continuous injection and NOT as a rapid dose. Some patients, especially dogs, may undergo a short period of apnoea on induction using Alfaxan Multidose by the intravenous route. This can be avoided by inducing anaesthesia by slow continuous intravenous injection over 60 seconds, while assessing the degree of anaesthesia achieved. Appropriate analgesia should be provided in cases where procedures are anticipated to be painful. As with all general anaesthetic agents: • It is advisable to ensure that the patient has been fasted before receiving the anaesthetic. • Additional monitoring is advised and particular attention should be paid to respiratory parameters in aged animals, or in cases where there may be additional physiological stress imposed by pre-existing pathology or shock. • Following induction of anaesthesia, the use of an endotracheal tube is recommended to RLP APPROVED maintain airway patency. • It is advisable to administer supplemental oxygen during maintenance of anaesthesia. • Respiratory embarrassment may occur – ventilation of the lungs with oxygen should be considered if haemoglobin saturation with oxygen (SpO2%) falls below 90% or if apnoea persists for longer than 60 seconds. • If cardiac arrhythmias are detected, attention to respiratory ventilation with oxygen is the first pri read_full_document
ALFAXAN MULTIDOSE ANAESTHETIC INJECTION Page 1 of 7 Issued by: Jurox Pty Limited Phone: 1800 023 312 POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA ISSUED: 29 MARCH 2018 SAFETY DATA SHEET SECTION 1: IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY PRODUCT NAME: ALFAXAN MULTIDOSE ANAESTHETIC INJECTION PRODUCT IDENTIFIER: 10 mg/mL Alfaxalone solution for injection. PRODUCT CODE: 520400 (20 mL); TBD (10 mL) RECOMMENDED USE: An injectable steroid anaesthetic for use in dogs and cats. It can be used as an induction agent prior to gaseous anaesthesia or as a sole anaesthetic agent for the induction and maintenance of anaesthesia for the performance of examination or surgical procedures. RESTRICTIONS ON USE: For animal treatment only. COMPANY IDENTIFICATION: Jurox Pty Limited ADDRESS: 85 Gardiner Street Rutherford NSW 2320 Australia CUSTOMER CENTRE: 1800 023 312 EMAIL: customerservice@jurox.com.au NATIONAL POISONS INFORMATION CENTRE: 13 1126 (24 hours) EMERGENCY TELEPHONE NUMBER: 1800 023 312 (9am – 5pm, Monday to Friday) SECTION 2: HAZARDS IDENTIFICATION GHS HAZARD CLASSIFICATIONS: This product has been assessed according to GHS and is classified as follows: GHS CATEGORY HAZARD CODE HAZARD STATEMENT Flammable Liquid Category 3 H226 Flammable liquid and vapour Eye Irritant Category 2A H319 Causes serious eye irritation GHS LABEL ELEMENTS: Signal Word: WARNING Pictograms: Flame Exclamation Mark ALFAXAN MULTIDOSE ANAESTHETIC INJECTION Page 2 of 7 Issued by: Jurox Pty Limited Phone: 1800 023 312 POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA Precautionary Statements: Prevention P210 Keep away from heat / sparks / open flames / hot surfaces – No smoking. P233 Keep container tightly closed. P241 Use explosion-proof electrical/ventilating/lighting/intrinsically safe equipment. P242 Use only non-sparking tools. P243 Take precautionary measures against static discharge. P264 Wash hands thoroughly after handling. P280 Wear protective gloves / eye protection / face protection. Response P370 + P37 read_full_document
WWW.JUROX.COM.AU Customer Service 1800 023 312 ® Registered Trademark of Jurox Pty Ltd TECHNICAL NOTES REGISTERED NAME Alfaxan® Anaesthetic Injection ACTIVE CONSTITUENTS Alfaxalone 10 mg/mL DESCRIPTION Alfaxan® is a clear, colourless, sterile solution for injection presented in a multi-use injection vial. ACTIONS Alfaxalone (3-α-hydroxy-5-α-pregnane-11,20-dione) is a neuroactive steroid molecule with properties of a general anaesthetic. The primary mechanism for the anaesthetic action of alfaxalone is modulation of neuronal cell membrane chloride ion transport, induced by binding of alfaxalone to GABA-A cell surface receptors. PHARMACOKINETIC PARTICULARS The volume of distribution after a single injection of clinical doses of Alfaxan® in dogs and cats is 2.4 L/kg and 1.8 L/kg, respectively. In cats, the mean terminal plasma elimination half-life (t1/2) for alfaxalone is approximately 45 minutes for a 5 mg/kg dose. Mean plasma clearance for a 5 mg/kg dose is 25.1 ± 7.6 mL/kg/min. In dogs, the mean terminal plasma elimination half-life (t1/2) for alfaxalone is approximately 25 minutes for a 2 mg/kg dose. Plasma clearance for a 2 mg/kg dose is 59.4 ± 12.9 mL/kg/min. Alfaxalone metabolites are likely to be eliminated from the dog and cat by the hepatic/faecal and renal routes, similar to other species. CONTRAINDICATIONS Alfaxan® is contraindicated for use in combination with other intravenous anaesthetic agents. ALFAXAN ® Anaesthetic Injection WWW.JUROX.COM.AU Customer Service 1800 023 312 ® Registered Trademark of Jurox Pty Ltd TECHNICAL NOTES PRECAUTIONS ALFAXAN® SHOULD BE GIVEN BY SLOW CONTINUOUS INJECTION AND NOT AS A RAPID DOSE. Some patients, especially dogs, may undergo a short period of apnoea on induction using Alfaxan® by the intravenous route. This can be avoided by inducing anaesthesia by slow continuous intravenous injection over 60 seconds, while assessing the degree of anaesthesia achieved. Appropriate analgesia should be provided in cases where procedures are anticipated to be painful. AS read_full_document