DESFLURANE Inhalation vapour liquid Ref.[9256] Active ingredients: Desflurane

Desflurane should be administered only by healthcare professionals trained in the administration of general anaesthesia using a vaporizer specifically designed and calibrated for use with desflurane.

Equipment for maintenance of a patent airway, artificial ventilation, oxygen enrichment and circulatory resuscitation must be immediately available.

Parameters such as ECG, blood pressure, oxygen saturation, and pCO2 upon exhaling must be monitored during anaesthesia (see section 4.4).

Posology

The administration of general anaesthesia must be individualized based on the patient’s response. It is determined depending on the desired effect, taking into consideration of the patient’s age and clinical status.

MAC (minimum alveolar concentration at which 50% of patients show no response to a standardized surgical incision) values for desflurane decreases with increasing patient age. The dose of desflurane should be adjusted accordingly.

The percentage concentration of desflurane corresponding to 1 MAC has been determined within carrier gas as listed in Table 1 below.

Table 1. Percentage concentration of desflurane corresponding to 1 MAC according to patient age and inhalation mixture (Mean ± SD):

N* = number of crossover pairs (using up-and-down method of quantal response)

Premedication

Premedication should be decided after considering the individual requirements of each patient. The use of anticholinergic medicinal products is a matter of choice for the anaesthetist.

Desflurane can be combined with other substances commonly used in anaesthesia, preferably intravenous opioids benzodiazepines and hypnotics. Opioids or benzodiazepines decrease the amount of desflurane required to produce anaesthesia.

The need of Desflurane also decreases with the concomitant use of nitrous oxide (N2O).

Desflurane reduces the recommended dose of neuromuscular inhibitors. (Please refer also to section 4.5)

Induction of Anaesthesia in Adults

Taking into account the poor tolerability of breathing desflurane in awake patient, the benefit risk ratio of such a procedure must be analysed on case by case basis.

In adults, a starting concentration of 3% is recommended, increased in 0.5- 1.0% increments every 2 to 3 breaths. Inspired concentrations of 4- 11% of desflurane usually produce surgical anaesthesia in 2-4 minutes.

Higher concentrations up to 15% may be used. Such concentrations of desflurane will proportionately dilute the concentration of oxygen and commencing administration of oxygen should be 30% or above.

During induction in adults, the overall incidence of oxyhemoglobin desaturation (SpO₂ <90%) was 6%. High concentrations of desflurane may induce upper airway adverse events.After induction in adults with an intravenous medicinal product such as thiopental or propofol, desflurane can be started at approximately 3.0% (0.5 MAC) - 6.0% (1 MAC), whether the carrier gas is O₂ or N₂O/O₂.

Continuous, short-lived excitement may appear during the induction of anaesthesia with desflurane.

Induction of Anaesthesia in Children

Desflurane should not be used for the induction of general anaesthesia in children because of the high frequency occurrence of coughing, breath holding, apnoea, laryngospasm and increased salivation (see section 4.3 and 4.4).

Maintenance of Anaesthesia in adults

Desflurane at 2.5-8.5% may be required when administered using oxygen or oxygen enriched air. In adults, surgical levels of anaesthesia may be sustained at a reduced concentration of desflurane (2-6%) when nitrous oxide is used concomitantly.

If high concentrations are used with nitrous oxide, it is important to ensure that the inhaled gaseous mixture contains a minimum of 25% oxygen.

Lower doses of desflurane are needed when using opioids, benzodiazepines or other sedatives (see section 4.5).

Maintenance of Anaesthesia in children

Desflurane is indicated for maintenance of anaesthesia in infants and children. Surgical levels of anaesthesia may be maintained in children with end-tidal concentrations of 5.2 to 10% desflurane with or without the concomitant use of nitrous oxide. Although end-tidal concentrations of up to 18% desflurane have been administered for short periods of time, if high concentrations are used with nitrous oxide it is important to ensure that the inspired mixture contains a minimum of 25% oxygen.

Desflurane should not be used for maintenance of anaesthesia in non- intubated children under the age of 6 years due to an increased incidence of respiratory adverse reactions (see section 4.3 and 4.4).

Use in Dental Surgery

The administration of [Product Name] for dental use must be limited only to hospitals and ambulatory/outpatient surgery (see section 4.3).

Special populations

Patients with Renal and Hepatic Impairment

Concentrations of 1-4% desflurane together with nitrous oxide or oxygen have been administered successfully in patients with chronic renal or hepatic impairment and during renal transplantation surgery. Because of low metabolism, dose adjustment in patients with renal and hepatic impairment is not necessary.

Induction in Neurosurgical Patients

Desflurane should be administered at 0.8 MAC or less and in conjunction with a barbiturate induction and hyperventilation (hypocapnia) until cerebral decompression in patients with known or suspected increase in cerebrospinal fluid pressure (CSFP). Appropriate attention must be paid to maintain cerebral perfusion pressure. (See section 4.4).

Use of desflurane in hypovolaemic, hypotensive and debilitated patients

As with other potent inhalation anaesthetics, a lower concentration of desflurane is recommended for use in these patients.

Method of administration

Desflurane is administered by inhalation.

Overdose Symptoms and Treatment

The symptoms of overdose of desflurane are anticipated to be similar to those of other volatile agents with a deepening of anaesthesia, cardiac and/or respiratory depression in spontaneous breathing patients, and hypotension in ventilated patients in whom hypercarbia and hypoxia may occur only at a late stage.

In the event of overdose, the following actions should be taken: Desflurane should be stopped, a clear airway should be established and assisted or controlled ventilation with pure oxygen should be initiated. The hemodynamic function must be properly supported and maintained.

Shelf life: 2 years.

Store below 30°C.

Store the bottle in an upright position with the cap tightly closed.

250 mL amber Type III glass bottle, and PVC coating on the outside of the bottle with HDPE/EPDM closure and an aluminium crimp.

Packaged product is supplied in boxes of 6.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Accidental exposure of health professionals to desflurane can lead to a risk of undesirable effects.