Special Warning : אזהרת שימוש

4.4.      Special warnings and precautions for use
It should be noted that spinal anaesthesia can sometimes cause major blockades involving paralysis of the intercostal muscles and diaphragm, particularly in pregnant women.

Caution should be observed in patients with AV block II or III, as local anaesthetics may decrease myocardial transmittance. The elderly and patients with severe hepatic disease, severe renal impairment or poor general health also require particular attention.

Patients treated with antiarrhythmic class III agents (e.g. amiodarone) should be monitored closely and ECG monitoring should be considered as the cardiac effects of bupivacaine and class III antiarrhythmics may be additive.

Intrathecal anaesthesia can lead to hypotension and bradycardia. The risk of such effects can be reduced by e.g. injection of a vasopressor. Hypotension should be treated immediately with administration of an intravenous sympathomimetic, and repeated if required.

Like all local anaesthetics, bupivacaine may cause acute toxic effects in the central nervous and cardiovascular systems if use results in high blood concentrations. This applies particularly after inadvertent intravascular administration or administration to highly vascularised areas.

Ventricular arrhythmia, ventricular fibrillation, sudden cardiovascular collapse and death have been reported in connection with high systemic concentrations of bupivacaine.
However, high systemic concentrations are unusual at the doses normally used for spinal anaesthesia.

An uncommon but serious undesirable effect of spinal anaesthesia is widespread or total spinal blockade resulting in cardiovascular and respiratory depression. The cardiovascular depression is caused by extensive sympathetic blockade which may result in hypotension and bradycardia, or even cardiac arrest. Respiratory depression can be caused by blockade of the nerve supply to the respiratory muscles, including the diaphragm.

There is an increased risk of widespread or total spinal blockade in elderly patients and patients in the late stages of pregnancy. The dose should therefore be reduced for these patients.


In rare cases, spinal anaesthesia may cause neurological damage, resulting in paresthesia, anaesthesia, motor weakness and paralysis. It is not believed that neurological conditions such as multiple sclerosis, hemiplegia, paraplegia and neuromuscular disturbances are negatively affected by spinal anaesthesia, but caution should be observed.

This medicine contains less than 1 mmol (23 mg) of sodium per millilitre, i.e. it is almost “sodium free”.

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