Do not use in combination with other intravenous anaesthetic agents.

During recovery, it is preferable that animals are not handled or disturbed. This may lead to paddling, minor muscle twitching or movements that are more violent. While better avoided, such reactions are clinically insignificant.

Appropriate analgesia should be provided in cases where procedures are anticipated to be painful

The safety of Alfaxan in animals less than 12 weeks of age has not been demonstrated.

Transient post induction apnoea frequently occurs, particularly in dogs. In such cases, endotracheal intubation and oxygen supplementation should be employed. Facilities for intermittent positive pressure ventilation should be available.

In order to minimise the possibility of apnoea, administer Alfaxan by slow intravenous injection and not as a rapid dose.

Especially when using higher doses of Alfaxan, a dose-dependent respiratory depression may occur. Oxygen and/or intermittent positive pressure ventilation should be administered to counteract the threatening hypoxaemia/hypercapnea. This should be particularly important in risky anaesthetic cases and whenever the anaesthesia is to be carried out for a longer period of time.

In both dogs and cats, the dose interval for maintenance of anaesthesia by intermittent bolus administration may require lengthening by more than 20%, or the maintenance dose by intravenous infusion may require reduction by more than 20%, when hepatic blood flow is severely diminished or hepatocellular injury is severe.

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, shock or caesarean section.

· Following induction of anaesthesia, the use of an endotracheal tube is recommended to 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 priority followed by appropriate cardiac therapy or intervention.

Psychomotor excitement may be encountered in a minority of dogs and cats recovering from Alfaxan anaesthesia. Post-anaesthetic recovery should thus take place in appropriate facilities and under sufficient supervision. Use of a benzodiazepine as the sole premedicant may increase the probability of psychomotor excitement.

If the product comes into contact with the eyes or skin, wash off immediately with water. In case of accidental self injection seek immediate medical attention and show the product literature to the doctor.

In clinical studies using Alfaxan, 44% of dogs and 19% of cats experienced post induction apnoea, which was defined as the cessation of breathing for 30 seconds or more. The mean duration of apnoea in these animals was 100 seconds in dogs and 60 seconds in cats. Endotracheal intubation and oxygen supplementation should therefore be employed.

The safety of the veterinary medicinal product has not been established in cases where pregnancy is to be continued or during lactation. Its effects upon fertility have not been evaluated. However, studies using alfaxalone in pregnant mice, rats and rabbits have demonstrated no deleterious effects on gestation of the treated animals, or on the reproductive performance of their offspring. The product should be used in pregnant animals according to the risk-benefit assessment performed by the veterinarian.

Alfaxan has been demonstrated to be safe when used in combination with the following premedicant classes:

The concomitant use of other CNS depressants should be expected to potentiate the depressant effects of Alfaxan, necessitating cessation of further administration of Alfaxan when the required depth of anaesthesia has been reached.

The use of one premedicant or a combination of premedicants often reduces the dose of Alfaxan required.

Premedication with alpha-2-adrenoceptor agonists such as xylazine and medetomidine can markedly increase the duration of anaesthesia in a dose dependent fashion. In order to shorten recovery periods it may be desirable to reverse the actions of these premedicants.

Benzodiazepines should not be used as sole premedicants in dogs and cats as the quality of anaesthesia in some patients may be sub-optimal. Benzodiazepines may be used safely and effectively in combination with other premedicants and Alfaxan.

Acute tolerance to overdose has been demonstrated up to 10 times the recommended dose of 2 mg/kg in the dog (i.e. up to 20 mg/kg) and up to 5 times the recommended dose of 5 mg/kg in the cat (i.e. up to 25 mg/kg). For both dogs and cats, these excessive doses delivered over 60 seconds cause apnoea and a temporary decrease in mean arterial blood pressure. The decrease in blood pressure is not life threatening and is compensated for by changes in heart rate. These animals can be treated solely by intermittent positive pressure ventilation (if required) with either room air or, preferably, oxygen. Recovery is rapid with no residual effects.

Not applicable.

In the absence of compatibility studies, the veterinary medicinal product must not be mixed with other veterinary medicinal products.