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

Emulsion for injection/infusion

Propofol 2 % (20 mg/1 ml) is a short-acting intravenous general anaesthetic for
- Induction and maintenance of general anaesthesia in adults and children > 3 years
- Sedation for diagnostic and surgical procedures, alone or in combination with local or
regional anaesthesia in adults and children > 3 years
- Sedation of ventilated patients >16 years of age in the intensive care unit

General anaesthesia in children over 3 years of age

Induction of anaesthesia:

For induction of anaesthesia Propofol should be titrated slowly until clinical signs show the onset of anaesthesia. The dose should be adjusted according to age and/or bodyweight. Most patients over 8 years of age require approximately 2.5 mg/kg bodyweight Propofol for induction of anaesthesia. In younger children, dose requirements may be higher (2.5 - 4 mg/kg bodyweight). 

Maintenance of general anaesthesia:

Anaesthesia can be maintained by administering Propofol 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, dose requirements may be higher.

 For ASA III and IV patients lower doses are recommended

Sedation for diagnostic and surgical procedures in adult patients

To provide sedation during surgical and diagnostic procedures, doses and administration rates should be adjusted according to the clinical response. Most patients will require 0.5 - 1 mg propofol/kg bodyweight over 1 to 5 minutes for onset of sedation. Maintenance of sedation may be accomplished by titrating Propofol Fresenius infusion to the desired level of sedation. Most patients will require 1.5 - 4.5 mg propofol/kg bodyweight/h. The infusion may be supplemented by bolus administration of 10 - 20 mg propofol (0.5 - 1 ml Propofol 2 % (20 mg/1 ml) Fresenius) if a rapid increase of the depth of sedation is required.

In patients older than 55 years and in patients of ASA grades III and IV lower doses of Propofol may be required and the rate of administration may need to be reduced

Sedation for diagnostic and surgical procedures in children over 3 years 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 bodyweight propofol for onset of sedation. Maintenance of sedation may be accomplished by titrating Propofol Fresenius infusion to the desired level of sedation. Most patients require 1.5 - 9 mg/kg/h propofol.

In ASA III and IV patients lower doses may be required. Sedation in patients over 16 years of age in the intensive care unit

When used to provide sedation for ventilated patients under intensive care conditions, it is recommended that Propofol Fresenius should be given by continuous infusion. The dose should be adjusted according to the depth of sedation required. Usually satisfactory sedation is achieved with administration rates in the range of 0.3 to 4.0 mg propofol/kg bodyweight/h. Rates of infusion greater than 4.0 mg propofol/kg bodyweight/h are not recommended (see section 4.4).

Administration of propofol by a target controlled infusion (TCI) system is not advised for sedation in the intensive care unit (ICU).