The use of one premedicant or a combination of premedicants often reduces the dose of the Summary of Product Characteristics veterinary medicinal product required. Premedication with alpha-2-adrenoceptor agonists References such as xylazine and medetomidine can markedly increase the duration of anaesthesia in a 1. Jurox and Ricera, An in vitro study evaluating the binding of alfaxalone protocol for canine surgical patients. 2009, Faculty of Veterinary 1. Name of the veterinary medicinal product ALFAXAN 10 mg/ml solution for injection for dose dependent fashion. In order to shorten recovery periods it may be desirable to reverse dogs, cats and pet rabbits 2. Qualitative and quantitative composition Active substance: the actions of these premedicants. Benzodiazepines should not be used as sole premedicants to various nuclear receptors (Ricera Study No. AA94464). Records in Medicine – University of Utrecht. alfaxalone 10 mg/ml For the full list of excipients, see section 6.1. 3. Pharmaceutical form Repeatable. Reliable. Relax. in dogs and cats as the quality of anaesthesia in some patients may be sub-optimal. House, 2010. 15. Jimenez, C.P., et al., Evaluation of the quality of recovery after Solution for injection Clear colourless solution 4. Clinical particulars 4.1 Target species Benzodiazepines may be used safely and effectively in combination with other premedicants Dogs, cats and non-food rabbits 4.2 Indications for use, specifying the target species As an and the veterinary medicinal product. Refer to section 4.3. 4.9 Amounts to be administered and 2. Jurox and Ricera, An in vitro study evaluating the binding of alfaxalone administration of propofol or alfaxalone for induction of anaesthesia induction agent prior to inhalation anaesthesia in cats, dogs and non food rabbits. As a sole administration route For intravenous use. Induction of anaesthesia: The induction dose of the to various abuse receptors (Ricera Study No. AA94047). Records in in dogs anaesthetized for magnetic resonance imaging. Veterinary anaesthetic agent for the induction and maintenance of anaesthesia for the performance veterinary medicinal product is based on data taken from controlled laboratory and field studies of examination or surgical procedures in cats and dogs. 4.3 Contraindications Do not use House, 2010. and is the amount of drug required for 9 of 10 patients (i.e. 90th percentile) to be successfully Anaesthesia and Analgesia, 2012. 39(2): p. 151-159. in combination with other intravenous anaesthetic agents. 4.4 Special warnings During induced for anaesthesia. Dosing recommendations for induction of anaesthesia are as follows: recovery, it is preferable that animals are not handled or disturbed. In dogs and cats, this 3. Muir, W., et al., The cardiorespiratory and anesthetic effects of clinical 16. Maddern, K., et al., Alfaxalone induction dose following administration may lead to paddling, minor muscle twitching or movements that are more violent. While DOGS CATS RABBITS and supraclinical doses of alfaxalone in cats. Veterinary Anaesthesia of medetomidine and butorphanol in the dog. Veterinary Anaesthesia better avoided, such reactions are clinically insignificant. 4.5 Special precautions for use and Analgesia, 2009. 36(1): p. 42-54. (i) Special precautions for use in animals The analgesic properties of alfaxalone are limited, Un-premedicated Premedicated Un-premedicated Premedicated Un-premedicated Premedicated and Analgesia, 2010. 37(1): p. 7-13. therefore appropriate peri-operative analgesia should be provided in cases where procedures mg/kg 3 2 5 5 5 4 4. Muir, W., et al., Cardiorespiratory and anesthetic effects of clinical and 17. Martinez Taboada, F. and P.J. Murison, Induction of anaesthesia with are anticipated to be painful. The safety of the veterinary medicinal product in animals less than 12 weeks of age (dogs and cats) and 16 weeks of age (rabbits) has not been demonstrated. mL/kg 0.3 0.2 0.5 0.5 0.5 0.4 supraclinical doses of alfaxalone in dogs. Veterinary Anaesthesia and alfaxalone or propofol before isoflurane maintenance in cats. Veterinary Transient post induction apnoea frequently occurs, particularly in dogs – see section 4.6 The dosing syringe should be prepared to contain the above dose. Administration should Analgesia, 2008. 35(6): p. 451-462. Record, 2010. 167(3): p. 85-89. for details. In such cases, endotracheal intubation and oxygen supplementation should be continue until the clinician is satisfied that the depth of anaesthesia is sufficient for employed. Facilities for intermittent positive pressure ventilation should be available. In 5. Whittem, T. and Pasloske, P., RD9604.03 – H005. Eight day target animal 18. Mathis, A., et al., Comparison of quality of recovery from anaesthesia endotracheal intubation, or until the entire dose has been administered. The necessary ® order to minimise the possibility of apnoea, administer the veterinary medicinal product by injection rate can be achieved by administration of one quarter (¼) of the calculated dose safety study of intravenous Alfaxan CD RTU in dogs administered every in cats induced with propofol or alfaxalone. Veterinary Anaesthesia and slow intravenous injection and not as a rapid dose. Especially when using higher doses of the every 15 seconds, so that the total dose, if required, would be administered over the first other day. 2004, Jurox Pty. Ltd. Analgesia, 2012. 39(3): p. 282-290. veterinary medicinal product, a dose-dependent respiratory depression may occur. Oxygen 60 seconds. If, 60 seconds after complete delivery of this first induction dose, intubation is and/or intermittent positive pressure ventilation should be administered to counteract still not possible, one further similar dose may be administered to effect. Maintenance of 6. Pasloske, K. and Whittem, T., JX9604.07-H004. A target animal safety 19. Murison, P.J. and F. Martinez Taboada, Effect of propofol and alfaxalone the threatening hypoxaemia/hypercapnea. This should be particularly important in risky anaesthesia: Following induction of anaesthesia with the veterinary medicinal product, the study in cats after administration of Alfaxan® CD RTU as single, anaesthetic cases and whenever the anaesthesia is to be carried out for a longer period of animal may be intubated and maintained on the veterinary medicinal product or an inhalation on pain after ovariohysterectomy in cats. Veterinary Record, 2010. time. In rabbits, oxygenation is essential before induction of anaesthesia and throughout the anaesthetic agent. In dogs and cats maintenance doses of the veterinary medicinal product repeated injections on days 0, 2 and 5 at doses of 5, 15 or 25 mg/kg. 166(11): p. 334-335. entire anaesthetic procedure to avoid potentially life threatening hypoxaemia. In dogs and may be given as supplemental boluses or as constant rate infusion. The veterinary medicinal 2004, 0n file at Jurox Pty Ltd. cats, the dose interval for maintenance of anaesthesia by intermittent bolus administration product has been used safely and effectively in dogs and cats for procedures lasting for up to 20. Psatha, E., et al., Clinical efficacy and cardiorespiratory effects of may require lengthening by more than 20%, or the maintenance dose by intravenous infusion one hour. The following doses suggested for maintenance of anaesthesia are based on data 7. Baron Strategic Services. Anaesthesia Market Research. Jurox vet survey may require reduction by more than 20%, when hepatic blood flow is severely diminished or alfaxalone, or diazepam/fentanyl for induction of anaesthesia in dogs taken from controlled laboratory and field studies and represent the average amount of drug hepatocellular injury is severe. In cats or dogs with renal insufficiency, doses for induction report Oct 11. On file at Jurox Pty. Ltd., Rutherford, NSW. Australia. that are a poor anaesthetic risk. Veterinary Anaesthesia and Analgesia, required to provide maintenance anaesthesia for each target species. However the actual and maintenance may require reduction. As with all general anaesthetic agents: It is advisable dose will be based on the response of the individual patient. Dosing recommendations for 8. Pasloske, K., et al., Plasma pharmacokinetics of alfaxalone in both 2011. 38: p. 24-36. to ensure that dogs and cats have been fasted before receiving the anaesthetic. Rabbits maintenance of anaesthesia are as follows: should not be fasted, but food should be removed one hour before anaesthesia. As with premedicated and un-premedicated Greyhound dogs after single, 21. Zaki, S., et al., Clinical evaluation of Alfaxan-CD® as an intravenous ® other intravenous anaesthetic agents, caution should be exercised in animals with cardiac DOGS CATS intravenous administration of Alfaxan at a clinical dose. Journal of or respiratory impairment, or in hypovolaemic or debilitated animals. Additional monitoring anaesthetic in young cats. Australian Veterinary Journal, 2009. 87(3): is advised and particular attention should be paid to respiratory parameters in aged animals, Un-premedicated Premedicated Un-premedicated Premedicated Veterinary Pharmacology and Therapeutics, 2009. 32: p. 510-513. p. 82-87. or in cases where there may be additional physiological stress imposed by pre-existing Dose for constant rate infusion 9. Metcalfe, S., et al., A multi-centre clinical trial evaluating the efficacy pathology, shock or caesarean section. Following induction of anaesthesia, the use of an 22. Child, K.J., et al., Metabolism and excretion of CT1341 in the rat. mg/kg/hour 8 - 9 6 - 7 10 - 11 7 - 8 ® endotracheal tube is recommended to maintain airway patency. It is advisable to administer and safety of Alfaxan administered to bitches for induction of In Steroid Anaesthesia, 1972. Royal College of Physicians, London. supplemental oxygen during maintenance of anaesthesia. Respiratory embarrassment may mg/kg/minute 0.13 - 0.15 0.10 - 0.12 0.16 - 0.18 0.11 - 0.13 anaesthesia prior to caesarean section. In 33rd World small Animal occur – ventilation of the lungs with oxygen should be considered if haemoglobin saturation mL/kg/minute 0.013 - 0.015 0.010 - 0.012 0.016 - 0.018 0.011 - 0.013 Congress. 2008. Dublin, Ireland: WSAVA/FECAVA.