Propofol – Lipuro 2%

/ Lapidot

Propofol-Lipuro 2% is given intravenously. The dosage is adjusted individually according to the patient’s
response.
General anaesthesia in adults
Induction of anaesthesia: For induction of anaesthesia Propofol-Lipuro 2% should be titrated (20 – 40 mg propofol every 10 seconds) against the patient’s response until the clinical signs show the onset of anaesthesia. Most adult patients younger than 55 years are likely to require 1.5 to 2.5 mg/kg body weight.
In patients over this age and in patients of ASA grades III and IV, especially those with impaired cardiac function, the dosage requirements will be less and the total dose of Propofol- Lipuro 2% may be reduced to 1 mg/kg body weight or less. In these patients lower rates of administration should be applied (approximately 1 ml corresponding to 20 mg every 10 seconds).
Maintenance of anaesthesia: Anaesthesia is maintained by administering Propofol-Lipuro 2% by continuous infusion. The dosage requirements usually are in the range of 4 – 12 mg/kg body weight/h.
In elderly patients, in patients of poor general condition, in patients of ASA grade III and IV and in hypovolaemic patients the dosage may have to be reduced further depending on the severity of the patient´s condition and on the performed anaesthetic technique.
General anaesthesia in children over 3 years of age
Induction of anaesthesia: For induction of anaesthesia Propofol-Lipuro 2% should be slowly titrated until the clinical signs show the onset of anaesthesia. The dosage should be adjusted according to age and/or body weight.
Most patients over 8 years of age require approximately 2.5 mg/kg body weight of propofol for induction of anaesthesia. In younger children, especially between the age of 1 month and 3 years, the dose requirements may be higher (2.5 – 4 mg/kg body weight).
Maintenance of general anaesthesia: Anaesthesia can be maintained by administering Propofol Lipuro 2% by infusion to maintain the depth of anaesthesia required. The required rate of administration varies considerably between patients but rates in the region of 9 – 15 mg/kg/h usually achieve satisfactory anaesthesia. In younger children, especially between the age of 1 month and 3 years, dose requirements may be higher.
For ASA III and IV patients lower doses are recommended.
See prescribing information for full details.

Propofol-Lipuro 2% is a short-acting intravenous general anaesthetic for
– induction and maintenance of general anaesthesia in adults and children>3 years.
– sedation of ventilated patients >16 years of age in the intensive care unit.
– sedation for diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia in adults and children>3 years.

Known hypersensitivity to propofol or to any of the constituents of the emulsion. Patients who are allergic to soya or peanut. Patients of 16 years of age or younger for sedation in intensive care.

Propofol should be given by those trained in anaesthesia (or, where appropriate, doctors trained in the care of patients in Intensive Care).
Patients should be constantly monitored and facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment and other resuscitative facilities should be readily available at all times. Propofol should not be administered by the person conducting the diagnostic or surgical procedure.
The abuse of and dependence on propofol, predominantly by health care professionals, have been reported.
As with other general anaesthetics, the administration of propofol without airway care may result in fatal respiratory complications.
When propofol is administered for conscious sedation, for surgical and diagnostic procedures, patients should be continually monitored for early signs of hypotension, airway obstruction and oxygen desaturation.
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.
An adequate period is needed prior to discharge of the patient to ensure full recovery after use of propofol. Very rarely the use of propofol may be associated with the development of a period of postoperative unconsciousness, which may be accompanied by an increase in muscle tone. This may or may not be preceded by a period of wakefulness. Although recovery is spontaneous, appropriate care of an unconscious patient should be administered.
Propofol induced impairment is not generally detectable beyond 12 hours. The effects of propofol, the procedure, concomitant medications, the age and the condition of the patient should be considered when advising patients on:
– The advisability of being accompanied on leaving the place of administration
– The timing of recommencement of skilled or hazardous tasks such as driving
– The use of other agents that may sedate (e.g. benzodiazepines, opiates, alcohol.)
As with other intravenous 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 that reduces cardiac output will also reduce propofol clearance.
See prescribing information for full details.

Nervous system disorders: Common: Headache during recovery phase.
Cardiac disorders: Common: Bradycardia.
Vascular disorders: Common: Hypotension
Respiratory, thoracic and mediastinal disorders: Common: Transient apnoea during induction.
Gastrointestinal disorders: Common: Nausea and vomiting during recovery
phase.
General disorders and administration site conditions: Very common: Local pain on induction.
See prescribing information for full details.

Propofol has been used in association with spinal and epidural anaesthesia and with commonly used premedicants, neuromuscular blocking drugs, inhalational agents and analgesic agents; no pharmacological incompatibility has been encountered. Lower doses of propofol may be required where general anaesthesia or sedation is used as an adjunct to regional anaesthetic techniques.
Profound hypotension has been reported following anaesthetic induction with propofol in patients treated with rifampicin.
The concurrent administration of other CNS depressants such as pre-Medication drugs, inhalation agents, analgesic agents may add to the sedative, anaesthetic and cardiorespiratory depressant effects of propofol.
A need for lower propofol doses has been observed in patients taking valproate.
When used concomitantly, a dose reduction of propofol may be considered.

Pregnancy: The safety of propofol during pregnancy has not been established. Propofol should not be given to pregnant women except when absolutely necessary. Propofol can, however, be used during an induced abortion.
Obstetrics: propofol crosses the placenta and can cause neonatal depression. It should not be used for obstetric anaesthesia unless clearly necessary.
Breast-feeding: Studies of breast-feeding mothers showed that small quantities of propofol are excreted in human milk. Woman should therefore not breastfeed for 24 hours after administration of propofol. Milk produced during this period should be discarded.

Accidental overdosage is likely to cause cardiorespiratory depression.
Respiratory depression should be treated by artificial ventilation with oxygen. Cardiovascular depression may require lowering the patient’s head and, if severe, use of plasma expanders and pressor agents.

Incompatibilities: This medicinal product must not be mixed with other medicinal products except those mentioned in the prescribing information.
Shelf life: 2 years. After first opening: to be used immediately.
Storage: Do not store above 25 °C.