As with other IV anaesthetic agents, caution should be applied in patients with cardiac, respiratory, renal or hepatic impairment or in hypovolaemic or debilitated patients. Propofol clearance is blood flow dependent, therefore, concomitant medication which reduces cardiac output will also reduce propofol clearance.
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 with Fresofol 1% MCT/LCT 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 of Fresofol 1% MCT/LCT is not recommended with electroconvulsive
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
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
Lipids should be monitored in the intensive care unit treatment every 2 days.
Due to a higher dosage in patients with severe overweight the risk of
haemodynamic effects on the cardiovascular system should be taken into
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
Lidocaine must not be used in patients with hereditary acute porphyria.
Fresofol 1% MCT/LCT is not advised for general anaesthesia in children <1 month of age.
Administration of Fresofol 1% MCT/LCT by a target controlled infusion
(TCI) system is not advised for the use in children.
In any case, special care should be exercised when propofol is used for
anaesthesia in infants and children >3 years of age, although
currently available data do not suggest significant differences in terms
of safety compared with children >3 years.
The safety of propofol for (background) sedation in the intensive care
unit in children and adolescents <16 years of age has not been
Although no causal relationship has been established, serious
undesirable effects with (background) sedation in patients <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, renal failure 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, arrhythmias and/or
rapidly progressive cardiac failure (in some cases with fatal outcome)
in adults who were treated for >48 hrs with dosages in excess of 5 mg
propofol/kg body weight/hr. This exceeds the maximum dosage of 4 mg
propofol/kg body weight/hr 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/hr. Prescribers should be alert to these
possible undesirable effects and consider decreasing the propofol dosage
or switching to an alternative sedative at the 1st sign of occurrence
of respective symptoms. Patients with raised ICP should be given
appropriate treatment to support the cerebral perfusion pressure during
these treatment modifications.
The use of Fresofol 1% MCT/LCT is not recommended for newborn infants as
this patient population has not been fully investigated.
Pharmacokinetic data indicate that clearance is considerably reduced in
neonates with a very high interindividual variability. Relative overdose
could occur administering doses recommended for older children
resulting in severe cardiovascular depression.
In isolated cases there may be a phase of postoperative unconsciousness
that may be accompanied by an increased muscular tone. The appearance of
this period is not dependent whether the patient came out of an
anaesthetic or not. Although consciousness is spontaneously regained the
unconscious patient should be kept under intensive observation.
Full recovery from general anaesthesia should be confirmed prior to discharge.
This medicinal product contains <1 mmol (23 mg) sodium per 100 mL, ie, essentially “sodium-free”.
Pharmaceutical Precautions: Containers should be shaken before use. If 2 layers can be seen after shaking, the emulsion should not be used.
Use only homogeneous preparations and undamaged containers.
Prior to use, the ampoule neck or rubber membrane should be cleaned using an alcohol spray or a swab dipped in alcohol.
After use, tapped containers must be discarded.
After opening, Fresofol 1% MCT/LCT must be used immediately.
Administration systems with the undiluted Fresofol 1% MCT/LCT should be replaced after 12 hrs.
Dilutions with 5% w/v glucose or 0.9% w/v sodium chloride or an admixture with 1% preservative-free lidocaine injection solution (at least 2 mg propofol per mL) should be prepared aseptically (controlled and validated conditions preserved) immediately before administration and administration should be completed within 6 hrs after preparation.
For single use. Any unused emulsion must be discarded.
Effects on the Ability to Drive and Operate Machinery:
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.