PROFOL 1% should be given by those trained in anaesthesia or, where appropriate; doctors trained in the care of patients in the intensive care. The facilities for maintenance of a patient airway, ventilation, oxygen enrichment and other resuscitative facilities should be readily available at all times. PROFOL 1% should not be administered by the person conducting the diagnostic or surgical procedure.
When PROFOL 1% is administered patients should be continually monitored for early signs of hypotension, airway obstruction and oxygen desaturation.
An adequate period is needed prior to discharge of the patients to ensure full recovery after general anaesthesia. As with other intravenous anaesthetic agents, caution should be applied in patients with cardiac, respiratory, renal or hepatic impairment or hypovolaemic or debilitated patients. Propofol lacks vagolytic activity and has been associated with reports of bradycardia, occasionally profound, and also asystole. The intravenous administration of anticholinergic agent before induction or during maintenance of anaesthesia should be considered, especially in situations where vagal tone is likely to predominate or when PROFOL 1% is used in conjunction with other agents likely to cause bradycardia.
When PROFOL 1% is administered to an epileptic patients there may be a risk of convulsion during the recovery phase.
Appropriate care should be applied in patients with disorders of fat metabolism and in other conditions where lipid emulsion must be used cautiously.
It is recommended that blood lipid levels should be monitored if PROFOL 1% is administered to patients thought to be at particular risk of fat overload. Administration of PROFOL 1% should be adjusted appropriately if the monitoring indicates that fat is being inadequately cleared from the body. If the patient is receiving other intravenous lipid concurrently, a reduction in quantity should be made in order to take account of the amount of lipid infused as part of the PROFOL 1% formulation; 1.0 ml of PROFOL 1% contains approximately 0.1 g of fat.
Additional Precautions: PROFOL 1% contains no antimicrobial preservatives and supports growth of micro-organisms.
When PROFOL 1% is to be aspirated, it must be drawn aseptically into a sterile syringe or giving set immediately after breaking the vial seal. Administration must commence without delay. Asepsis must be maintained for both PROFOL 1% and infusion equipment throughout the infusion period. Any infusion fluids added to the PROFOL 1% must be administered close to the cannula site. PROFOL 1% must not be administered via a microbiological filter. PROFOL 1% is for single use in an individual patient. For use in long term maintenance of anaesthesia it is recommended that the infusion line and reservoir of PROFOL 1% must be discarded and replaced at regular intervals.
Effects on the Ability to Drive and Operate Machinery: Patients should be advised that performance of skilled tasks, such as driving and operating machinery, may be impaired for some time after general anaesthesia.
Use in Pregnancy: PROFOL 1% should not be used in pregnancy. Propofol has been used, however during termination of pregnancy in the first trimester.
Obsterics: Propofol crosses the placenta and may be associated with neonatal depression, it should not be used for obstetric anaesthesia.
Use in Lactation: Safety to the neonate following the use of PROFOL 1% in mothers who are breast feeding has not been established.