Fresofol 1% MCT/LCT

Propofol

Induction & maintenance of general anaesth; sedation of artificially ventilated patients in ICU; sedation for diagnostic & surgical procedures alone or in combination w/ local or regional anaesth.

IV Individualized dosage. Induction of anesth Titrate approx 20-40 mg every 10 sec. Adult <55 yr 1.5-2.5 mg/kg, >55 yr & patients w/ American Society of Anethesiologist (ASA) grades III & IV Total dose may be reduced to a min of 1 mg/kg at approx (2 mL) 20 mg every 10 sec. Childn Initially 3 mg/kg, >8 yr Approx 2.5 mg/kg. Maintenance of anesth Administer as continuous infusion or repeat bolus inj. Adult 4-12 mg/kg/hr. May be reduced to approx 4 mg/kg/hr during less stressful surgical procedures. May also be given as repeat bolus inj w/ dose increments of 25-50 mg according to clinical requirements. Elderly, patients w/ unstable general condition, impaired cardiac function or hypovolemia & patients of ASA grades III & IV Reduce dose according to severity of condition & anesth technique. Childn 9-15 mg/kg/hr, <3 yr May require higher dose. Max duration: 60 min. Sedation during intensive care Adult 0.3-4 mg/kg/hr by continuous infusion. Max: 4 mg/kg/hr. Sedation for diagnostic & surgical procedures Adult 0.5-1 mg/kg over 1-5 min for onset of sedation. Maintenance: 1.5-4.5 mg/kg/hr. May be supplemented by 10-20 mg bolus infusion for rapid increase of depth of sedation. Max duration: 7 days.

Hypersensitivity. Allergy to soya or peanut. Sedation in childn ≤16 yr.

Severe allergic reactions w/ soybean oil. Not to be mixed w/ other soln for infusion or inj. Not to be administered via microbiological filter. Not to be administered in patients w/ advanced cardiac failure or other severe myocardial disease except w/ extreme caution & intensive monitoring. Not recommended w/ electroconvulsive therapy. Not to use dilutions w/ lidocaine soln in patients w/ hereditary acute porphyria. May increase risk of seizure in epileptic patients; relative vagotonia. Bradycardia & asystole. Involuntary patient movements when used for sedation during operative procedures. Patients w/ cardiac & resp impairment, hypovolaemia; epilepsy or disorders of consciousness & fat metabolism; other conditions where lipid emulsions must be used w/ caution; high ICP & low mean arterial pressure. Risk of haemodynamic effects on CV system in severely overwt patients. Compensate cardiac, circulatory or pulmonary insufficiency & hypovolaemia before administration. Check if epileptic patient has received antiepileptic treatment before anaesth. Consider IV anticholinergic agent before induction, or during maintenance of anaesth especially where vagal tone is likely to predominate, or when used concomitantly w/ other agents causing bradycardia. Monitor lipids in ICU treatment after 3 days. Closely observe unconscious patients. Avoid alcohol consumption. Do not drive, operate machinery or work in potentially hazardous situations. Renal or hepatic impairment. Not to be used during pregnancy. Discontinue lactation & discard breast milk for 24 hr after administration. Not for general anaesth in childn <1 mth. Infant. Not for sedation in patients ≤16 yr. Elderly. Debilitated patients.

Local pain during initial inj. Spontaneous movements & myocloni, minimal excitation; hypotension, bradycardia, tachycardia, hot flashes; resp depression, hyperventilation, transient apnoea, coughing, singultus.

Increased effects w/ centrally acting medicinal products eg, premed, volatile & local anaesth, analgesics, muscle relaxants. Prolonged anaesth & reduced resp rate w/ benzodiazepines, parasympatholytics or inhalational anaesth. Intensified & prolonged sedative effects after additional premed w/ opioids. Potentiated anaesth & CV side effects w/ premed medicinal products, inhalation or analgesic agents. Intensified sedative effects of CNS depressants eg, alcohol, general anaesth, narcotic analgesics. Temporary increased blood level w/ fentanyl. Bradycardia & cardiac arrest w/ suxamethonium or neostigmine. Leucoencephalopathy w/ cyclosporine.

Anaesthetics - Local & General

N01AX10 - propofol ; Belongs to the class of other general anesthetics.

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