Fresofol 1% MCT/LCT

Fresofol 1% MCT/LCT Special Precautions



Fresenius Kabi


The Glory Medicina
Full Prescribing Info
Special Precautions
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 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 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 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.
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 demonstrated.
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.
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