Propofol, Soya-bean oil, refined , Triglycerides medium-chain, egg lecithin, Glycerol, sodium oleate, Sodium hydroxide, water for injection

Emulsion for injection/infusion

Propofol 1% is a short-acting intravenous general anaesthetic for:
• Induction and maintenance of general anaesthesia in adults and children
>1 month.
• Sedation for diagnostic and surgical procedures, alone or in combination
with local or regional anaesthesia in adults and children >1 month.
Sedation of ventilated patients >16 years of age in the intensive care unit

Maintenance of General Anaesthesia

Adults 

Anaesthesia can be maintained by administering Propofol 1% either by continuous infusion or by repeat bolus injections to prevent the clinical signs of light anaesthesia.

Recovery from anaesthesia is typically rapid and it is therefore important to maintain Propofol 1% administration until the end of the procedure.

• Continuous Infusion The required rate of administration varies considerably between patients, but rates in the region of 4–12 mg/kg/h usually maintain satisfactory anaesthesia.

• Repeat Bolus Injections If a technique involving repeat bolus injections is used, increments of 25 mg (2.5 ml) to 50 mg (5.0 ml) may be given according to clinical need.

Elderly

When Propofol 1% is used for maintenance of anaesthesia the rate of infusion or ‘target concentration’ should also be reduced. Patients of ASA grades 3 and 4 will require further reductions in dose and dose rate. Rapid bolus administration (single or repeated) should not be used in older people as this may lead to cardiorespiratory depression.

Paediatric population

Propofol 1% is not recommended for maintenance of anaesthesia in children aged less than 1 month.

Anaesthesia can be maintained in children over 1 month of age by administering Propofol 1% by infusion or repeated bolus injection 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 3 and 4 patients lower doses are recommended (see also Section 4.4). Administration of Propofol 1% by a 'Diprifusor' TCI system is not recommended for maintenance of general anaesthesia in children.

Sedation During Intensive Care

Adults

For sedation during intensive care it is advised that Propofol 1% should be administered by continuous infusion. The infusion rate should be determined by the desired depth of sedation. In most patients sufficient sedation can be obtained with a dosage of 0.3–4 mg/kg/h of Propofol 1% (See 4.4 Special warnings and precautions for use). Propofol 1% is not indicated for sedation in intensive care of patients of 16 years of age or younger (see 4.3 Contraindications). Administration of Propofol 1% by Diprifusor TCI system is not advised for sedation in the intensive care unit.

Propofol 1% may be diluted with 5% Dextrose (see "Dilution and Co-administration" table below).

It is recommended that blood lipid levels be monitored should Propofol 1% be administered to patients thought to be at particular risk of fat overload. Administration of Propofol 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 Propofol 1% formulation; 1.0 ml of Propofol 1% contains approximately 0.1g of fat.

If the duration of sedation is in excess of 3 days, lipids should be monitored in all patients.

Elderly

When Propofol 1% is used for sedation the rate of infusion should also be reduced. Patients of ASA grades 3 and 4 will require further reductions in dose and dose rate. Rapid bolus administration (single or repeated) should not be used in older people as this may lead to cardiorespiratory depression.

Paediatric population

Propofol 1% is contraindicated for the sedation of ventilated children aged 16 years or younger receiving intensive care.

Sedation For Surgical And Diagnostic Procedures

Adults

To provide sedation for surgical and diagnostic procedures, rates of administration should be individualised and titrated to clinical response. Most patients will require 0.5–1 mg/kg over 1– 5 minutes for onset of sedation.

Maintenance of sedation may be accomplished by titrating Propofol 1% infusion to the desired level of sedation - most patients will require 1.5–4.5 mg/kg/h. In addition to the infusion, bolus administration of 10–20 mg may be used if a rapid increase in the depth of sedation is required. In patients of ASA Grades 3 and 4 the rate of administration and dosage may need to be reduced.

Administration of Propofol 1% by a ‘Diprifusor’ TCI system is not recommended for sedation for surgical and diagnostic procedures.

Elderly

When Propofol 1% is used for sedation the rate of infusion or ‘target concentration’ should also be reduced. Patients of ASA grades 3 and 4 will require further reductions in dose and dose rate. Rapid bolus administration (single or repeated) should not be used in older people as this may lead to cardiorespiratory depression.

Paediatric population

Propofol 1% is not recommended for surgical and diagnostic procedures in children aged less than 1 month.

In children over 1 month of age, doses and administration rates should be adjusted according to the required depth of sedation and the clinical response. Most paediatric patients require 1– 2 mg/kg body weight of Propofol 1% for onset of sedation. Maintenance of sedation may be accomplished by titrating Propofol 1% infusion to the desired level of sedation. Most patients require 1.5–9 mg/kg/h Propofol 1%. The infusion may be supplemented by bolus administration of up to 1 mg/kg body weight if a rapid increase of depth of sedation is required.

In ASA 3 and 4 patients lower doses may be required.