SEVOFLURANE Inhalation Vapour, liquid Ref.[9254] Active ingredients: Sevoflurane

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: AbbVie Ltd., Maidenhead, SL6 4UB, United Kingdom

Therapeutic indications

Sevoflurane is indicated for induction and maintenance of general anaesthesia in adult and paediatric patients for inpatient and outpatient surgery.

Posology and method of administration

Premedication should be selected according to the need of the individual patient, and at the discretion of the anaesthetist.

Surgical Anaesthesia

Sevoflurane should be delivered via a vaporiser specifically calibrated for use with sevoflurane so that the concentration delivered can be accurately controlled. MAC (minimum alveolar concentration) values for sevoflurane decrease with age and with the addition of nitrous oxide. The table below indicates average MAC values for different age groups.

Table 1. MAC values for Adults and Paediatric patients according to age:

Age of Patient (years) Sevoflurane in Oxygen Sevoflurane in 65% N2O/35% O2
0–1 months* 3.3% 2.0%**
1 - <6 months3.0%
6 months - <3 years2.8%
3-122.5%
252.6%1.4%
402.1%1.1%
601.7%0.9%
801.4%0.7%

* Neonates are full term gestational age. MAC in premature infants has not been determined.
** In 1 – <3 year old paediatric patients, 60% N2O/40% O2 was used.

Induction:

Dosage should be individualised and titrated to the desired effect according to the patient’s age and clinical status. A short acting barbiturate or other intravenous induction agent may be administered followed by inhalation of sevoflurane. Induction with sevoflurane may be achieved in oxygen or in combination with oxygen-nitrous oxide mixtures. In adults inspired concentrations of up to 5% sevoflurane usually produce surgical anaesthesia in less than 2 minutes. In children, inspired concentrations of up to 7% sevoflurane usually produce surgical anaesthesia in less than 2 minutes. Alternatively, for induction of anaesthesia in unpremedicated patients, inspired concentrations of up to 8% sevoflurane may be used.

Maintenance

Surgical levels of anaesthesia may be sustained with concentrations of 0.5-3% sevoflurane with or without the concomitant use of nitrous oxide.

Emergence

Emergence times are generally short following sevoflurane anaesthesia. Therefore, patients may require early post-operative pain relief.

Older people

MAC decreases with increasing age. The average concentration of sevoflurane to achieve MAC in an 80 year old is approximately 50% of that required in a 20 year old.

Paediatric population

Refer to Table 1 for MAC values for paediatric patients according to age.

Overdose

In the event of overdosage, the following action should be taken: Stop drug administration, establish a clear airway and initiate assisted or controlled ventilation with pure oxygen and maintain adequate cardiovascular function.

Shelf life

Shelf life: The recommended shelf life is 36 months.

Special precautions for storage

Do not store above 25°C. Do not refrigerate. Keep cap tightly closed.

Nature and contents of container

100ml and 250ml amber polyethylene napthalate (PEN) bottles.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Sevoflurane should be administered via a vaporiser calibrated specifically for sevoflurane using a key filling system designed for sevoflurane specific vaporisers or other appropriate sevoflurane specific vaporiser filling systems.

Carbon dioxide absorbents should not be allowed to dry out when inhalational anaesthetics are being administered. Some halogenated anaesthetics have been reported to interact with dry carbon dioxide absorbent to form carbon monoxide. However, in order to minimise the risk of formation of carbon monoxide in re-breathing circuits and the possibility of elevated carboxyhaemoglobin levels, CO2 absorbents should not be allowed to dry out. There have been rare cases of excessive heat production, smoke and fire in the anaesthetic machine when sevoflurane has been used in conjunction with a desiccated (dried out) CO2 absorbent. If the CO2 absorbent is suspected to be desiccated it should be replaced.

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

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