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

5.1. Pharmacodynamic properties

Isoflurane is an inhalation-type anaesthetic, belonging to the group of halogenated anaesthetics. Induction and recovery from anaesthesia take place rapidly with isoflurane.

Isoflurane has the slightly irritating odour of ether, which can limit the speed of induction.

Pharyngeal and laryngeal reflexes are rapidly diminished as a result of which tracheal intubation is rendered easy.

5.2. Pharmacokinetic properties

AErrane is metabolised minimally in comparison to other halogenated anaesthetics. On average 95% of the AErrane is recovered in the expired air; 0.2% of the AErrane that is taken up within the body is metabolised. The principal metabolite is trifluoroacetic acid. The average serum level of inorganic fluoride in patients administered AErrane anaesthesia is between 3 and 4 micromol/litre.

In patients anaesthetised with isoflurane, the mean serum concentration of inorganic fluorides is usually less than 5 micromol/litre and occurs about four hours after anaesthesia, returning to normal levels within 24 hours. This should not alter renal function in a normal subject.

5.3. Preclinical safety data

Published studies in animals (including primates) at doses resulting in light to moderate anaesthesia demonstrate that the use of anaesthetic agents during the period of rapid brain growth or synaptogenesis results in cell loss in the developing brain that can be associated with prolonged cognitive deficiencies. The clinical significance of these nonclinical findings in not known.

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