FRESOFOL

What it is

FRESOFOL is a sterile, milky white, isotonic, oil in water emulsion for intravenous infusion or injection . It is a short-acting intravenous anaesthetic agent . FRESOFOL is available in two strengths: 1% containing 10 mg propofol per 1 mL, and 2% containing 20 mg propofol per 1 mL .

Approved indications

— Induction of general anaesthesia in adults and children aged one month and older . — Maintenance of general anaesthesia in adults and children aged 3 years and older . — Maintenance of general anaesthesia in children aged from one month to 3 years for procedures not exceeding 60 minutes, unless alternative anaesthetic agents should be avoided . — Sedation of ventilated patients receiving intensive care in patients aged over 16 years . — Monitored conscious sedation for surgical and diagnostic procedures in adults .

Dosing overview

**Induction of general anaesthesia in adults:** Propofol should be titrated (20–40 mg every 10 seconds) against patient response until the onset of anaesthesia. Most adult patients less than 55 years are likely to require 1.5 to 2.5 mg of propofol per kg body weight . In elderly patients, requirements will be generally less .

**Maintenance of general anaesthesia in adults:** Continuous infusion rates in the region of 0.067 to 0.2 mg/kg body weight per minute (4 to 12 mg/kg body weight per hour) usually maintain satisfactory anaesthesia . If a technique involving repeat bolus injections is used, increments of 25 to 50 mg may be given according to clinical need .

**Sedation during intensive care in adults:** Usually satisfactory sedation is achieved with dosages in the range of 0.3–4.0 mg of propofol per kg body weight per hour .

**Conscious sedation for surgical and diagnostic procedures:** Most patients will require 0.5–1 mg of propofol per kg body weight over 1 to 5 minutes for onset of sedation . Maintenance may be accomplished by titrating propofol infusion—most patients will require 1.5–4.5 mg of propofol per kg body weight per hour .

Key safety warnings

The most commonly observed adverse effects are hypotension and respiratory depression. During induction, hypotension and transient apnoea occurred in up to 75% of patients . Hypotension and apnoea commonly occur during induction of anaesthesia . Propofol infusion syndrome is a life-threatening adverse event that can occur during sedation in intensive care. Very rare reports of propofol infusion syndrome have been observed in adults treated for more than 48 hours with propofol infusions in excess of 5 mg/kg/hour, in some cases with a fatal outcome . Major risk factors for the development of these events include decreased oxygen delivery to tissues, serious neurological injury and/or sepsis, and high dosages of vasoconstrictors, steroids, inotropes and/or propofol . FRESOFOL contains no antimicrobial preservatives and supports growth of microorganisms. It must be drawn up aseptically into a sterile syringe or infusion set immediately after opening the ampoule, vial or bottle . The duration of continuous infusion from one infusion system must not exceed 12 hours. The infusion line and reservoir must be discarded and replaced after 12 hours at the latest . Because FRESOFOL is formulated in an oil-in-water emulsion, elevations in serum triglycerides may occur when administered for extended periods of time . Patients at risk of hyperlipidaemia should be monitored for increases in serum triglycerides or serum turbidity .

Contraindications

FRESOFOL is contraindicated in patients with a known hypersensitivity to propofol or to any of the other ingredients (soya oil, medium chain triglycerides, glycerol, egg lecithin, and sodium oleate), and in patients who are allergic to soya or peanut . FRESOFOL is contraindicated for induction and maintenance of general anaesthesia in children younger than 1 month . FRESOFOL is contraindicated in patients of 16 years of age or younger for sedation during intensive care and for monitored conscious sedation for surgical and diagnostic procedures .

Regulatory history

FRESOFOL 1% was first listed on the ARTG on 23 November 2012 in three pack sizes: 200 mg/20 mL ampoule, 500 mg/50 mL vial, and 1000 mg/100 mL vial .