AERRANE Liquid for inhalation Ref.[27630] Active ingredients: Isoflurane

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Baxter Healthcare Ltd, Caxton Way, Thetford, Norfolk IP24 3SE, United Kingdom

4.1. Therapeutic indications

AErrane is a volatile halogenated anaesthetic for general inhalation anaesthesia.

4.2. Posology and method of administration

In order to be able to accurately control the precise concentration of isoflurane, vaporisers that have been specially calibrated for isoflurane should be used.

In order to be able to accurately control the precise concentration of isoflurane, vaporisers that have been specially calibrated for isoflurane should be used.

Induction of anaesthesia

If isoflurane is used for induction of anaesthesia, a starting concentration of 0.5% is recommended. Concentrations of 1.3-3.0% usually bring about surgical anaesthesia within 7 to 10 minutes.

It is recommended that use be made of a hypnotic dose of a short acting barbiturate or another product such as propofol, etomidate, or midazolam in order to avoid coughing or laryngospasms, which can arise if induction is carried out with AErrane alone or in combination with oxygen or with an oxygen-nitrous oxide mixture.

Maintenance of anaesthesia

Anaesthesia can be maintained during surgery using a concentration of 1.0-2.5% with the simultaneous administration of N2O and O2.

A higher concentration of 1.5-3.5% of AErrane is necessary if AErrane is administered with pure oxygen.

Recovery

The concentration of AErrane must be reduced to 0.5% at the end of the operation, or to 0% during closure of the wound to allow prompt recovery.

If all administration of anaesthetic agents has been stopped, the air passages of the patient should be ventilated several times with 100% oxygen until complete awakening occurs.

If the vector gas is a mixture of 50% O2 and 50% N2O, the value of the minimum alveolar concentration of isoflurane is approximately 0.65%.

ADULTS
AgeAverage MAC Value in 100% Oxygen70% N2O
26 ± 4 years1.28%0.56%
44 ± 7 years1.15%0.50%
64 ± 5 years1.05%0.37%
PAEDIATRIC POPULATION
AgeAverage MAC Value in 100% Oxygen 
Preterm neonates
<32 weeks gestational age
1.28%  
Preterm neonates
32-37 weeks gestational age
1.41%  
0-1 month1.60%  
1-6 months1.87%  
6-12 months1.80%  
1-5 years1.60%  

Premedication

Drugs used for premedication should be selected for the individual patient bearing in mind the respiratory depressant effect of isoflurane. The use of anticholinergic drugs is a matter of choice, but may be advisable for inhalation induction in paediatrics.

Induction of anaesthesia in children

Isoflurane is not recommended for use as an inhalation induction agent in infants and children because of the occurrence of cough, breath-holding, desaturation, increased secretions and laryngospasm (see section 4.4).

4.9. Overdose

In case of overdosage, stop administration of the anaesthetic agent.

Hypotension and respiratory depression have been observed. Close monitoring of blood pressure and respiration is recommended. Supportive measures may be necessary to correct hypotension and respiratory depression resulting from excessively deep levels of anaesthesia. Check whether air passages are open, and depending on the circumstances, continue with assisted or controlled respiration using pure oxygen.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

None.

6.5. Nature and contents of container

AErrane is supplied in 100 ml and 250ml bottles with screw cap closures.

6.6. Special precautions for disposal and other handling

See under section 4.2, Posology and Method of Administration.

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