Fresofol 1% MCT/LCT Special Precautions

In patients with cardiac, respiratory, renal or hepatic impairment or in elderly, debilitated, hypovolaemic or epileptic patients or patients with disorders of consciousness.
Fresofol 1% MCT/LCT should be administered with caution and a reduced administration rate (see Dosage & Administration).
Cardiac, circulatory or pulmonary insufficiency and hypovolaemia should be compensated before administration of Fresofol 1% MCT/LCT.
Before anaesthesia of an epileptic patient, it should be checked that the patient has received the antiepileptic treatment. Although several studies have demonstrated efficacy in treating status epilepticus, administration of propofol in epileptic patients may also increase the risk of seizure.
Fresofol 1% MCT/LCT should not be administered in patients with advanced cardiac failure or other severe myocardial disease except with extreme caution and intensive monitoring.
The risk of relative vagotonia may be increased because propofol lacks vagolytic activity. It has been associated with reports of bradycardia (occasionally profound) and also asystole. The intravenous administration of an anticholinergic agent before induction, or during maintenance of anaesthesia should be considered, especially in situations where vagal tone is likely to predominate, or when Fresofol 1% MCT/LCT is used in conjunction with other agents likely to cause a bradycardia.
Use is not recommended with electroconvulsive therapy.
As with other sedative agents, when propofol is used for sedation during operative procedures, involuntary patient movements may occur. During procedures requiring immobility, these movements may be hazardous to the operative site.
Special care should be applied in patients with disorders of fat metabolism and in other conditions where lipid emulsions must be used with caution. If patients receive parenteral nutrition, it is necessary to take account of the amount of lipid infusion as part of the Fresofol 1% MCT/LCT formulation: 1.0 ml Fresofol 1% MCT/LCT contains 0.1 gram of fat.
Lipids should be monitored in the Intensive Care Unit treatment after 3 days.
Due to a higher dosage in patients with severe overweight, the risk of haemodynamic effects on the cardiovascular system should be taken into consideration.
Special care should be recognised in patients with a high intracranial pressure and a low mean arterial pressure as there is a risk of a significant decrease of the intracerebral perfusion pressure.
To reduce pain on the injection site during induction of anaesthesia with Fresofol 1% MCT/LCT, lidocaine can be injected prior to the propofol emulsion.
Dilutions with lidocaine solution must not be used in patients with hereditary acute porphyria.
Propofol is not advised for general anaesthesia in children younger than 1 month of age. The safety of propofol for (background) sedation in children younger than 16 years of age have not been demonstrated.
Although no causal relationship has been established, serious undesirable effects with (background) sedation in patients younger than 16 years of age (including cases with fatal outcome) have been reported during unlicensed use. In particular, these effects concerned occurrence of metabolic acidosis, hyperlipidemia, rhabdomyolysis and/or cardiac failure. These effects were most frequently seen in children with respiratory tract infections who received dosages in excess of those advised in adults for sedation in the intensive care unit. Similarly, very rare reports have been received of occurrence of metabolic acidosis, rhabdomyolysis, hyperkalaemia and/or rapidly progressive cardiac failure (in some cases with fatal outcome) in adults who were treated for more than 58 hours with dosages in excess of 5 mg propofol/kg body weight/h. This exceeds the maximum dosage of 4 mg propofol/kg body weight/h currently advised for sedation in the intensive care unit. The patients affected were mainly (but not only) seriously head-injured patients with increased intracranial pressure (ICP). The cardiac failure in such cases was usually unresponsive to inotropic supportive treatment.
Treating physicians are reminded if possible not to exceed the dosage of 4 mg propofol/kg body weight/h.
Prescribers should be alert to these possible undesirable effects and consider decreasing the propofol dosage or switching to an alternative sedative at the first sign of occurrence of symptoms. Patients with raised ICP should be given appropriate treatment to support the cerebral perfusion pressure during these treatment modifications.
Special care should be exercised when propofol is used for anaesthesia in infants and children up to 3 years of age, although currently available data do not suggest significant differences in terms of safety compared with children older than 3 years.
In isolated cases, there may be a phase of postoperative unconsciousness that may be accompanied by an increased muscle tone. The occurrence of such an event is not related to whether the patient was awake or not. Although consciousness returns spontaneously, unconscious patients should be kept under close observation.
Fresofol 1% MCT/LCT contains soybean oil, which might cause severe allergic reaction in rare cases.
Full recovery from general anaesthesia should be confirmed prior to discharge.
Effects on Ability to Drive and Use Machines: After administration of Fresofol 1% MCT/LCT, the patient should be kept under observation for an appropriate period of time. The patient should be instructed not to drive, operate machinery or work in potentially hazardous situations. The patient should not be allowed to go home unaccompanied and should be instructed to avoid consumption of alcohol.