Posology : מינונים

4.2      Posology and method of administration

General instructions
Propofol-Lipuro 2% must only be given in hospitals or adequately equipped day therapy units by phy- sicians trained in anaesthesia or in the care of patients in intensive care. Circulatory and respiratory functions should be constantly monitored (e.g. ECG, pulse-oxymeter) and facilities for maintenance of patent airways, artificial ventilation, and other resuscitation facilities should be immediately available at all times. For sedation during surgical or diagnostic procedures Propofol-Lipuro 2% should not be given by the same person that carries out the surgical or diagnostic procedure.

Supplementary analgesic medicinal products are generally required in addition to Propofol-Lipuro 2%.

Posology
Propofol-Lipuro 2% is given intravenously. The dosage is adjusted individually according to the pa- tient’s response.

●     General anaesthesia in adults

Induction of anaesthesia:
Administration of Propofol 2% by bolus injection is not recommended.
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 car- diac function, the dosage requirements will be less and the total dose of Propofol- Lipuro 2% may be reduced to a minimum of 1 mg/kg body weight. 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.
Administration of Propofol 2% by bolus injection is not recommended.
In elderly patients, in patients of poor general condition, in patients of ASA grades 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.
Rapid bolus administration (single or repeated) should not be used in older people as this may lead to cardiorespiratory depression.

●   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 induc- tion of anaesthesia. In younger children, 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, dose requirements may be higher.

For ASA III and IV patients lower doses are recommended (see also section 4.4).

●   Sedation of ventilated patients in the intensive care unit
For sedation during intensive care, it is advised that Propofol-Lipuro 2% 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 – 4.0 mg of propofol per kg body weight per hour (see section 4.4).

Propofol is not indicated for sedation of patients of 16 years or younger in intensive care (see section 4.3). Administration of propofol by Target Controlled Infusion (TCI) system is not advised for seda- tion in the intensive care unit.

Rapid bolus administration (single or repeated) should not be used in older people as this may lead to cardiorespiratory depression.

●   Sedation for diagnostic and surgical procedures in adults

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/kg body weight over 1 to 5 minutes for onset of sedation. Maintenance of sedation may be accomplished by titrating Propofol-Lipuro 2% infusion to the desired level of sedation. Most patients will require 1.5 – 4.5 mg/kg body weight/h.
In patients older than 55 years and in patients of ASA grade III and IV lower doses of Propofol-Lipuro 2% may be required and the rate of administration may need to be reduced.
Rapid bolus administration (single or repeated) should not be used in older people as this may lead to cardiorespiratory depression.

According to required dose, alternatively Propofol 1 % may be used.

●   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 body weight of propofol for onset of sedation. Maintenance of sedation may be accomplished by titrating of propofol infusion to the desired level of sedation. Most patients require 1.5 – 9 mg/kg/h of propofol.

In ASA III and IV patients lower doses may be required.

Method and duration of administration
●   Method of administration

Intravenous use

Propofol-Lipuro 2% is administered undiluted intravenously. Containers should be shaken before use.
Before use, the surface of the rubber stopper of the vial should be cleaned with medicinal alcohol (spray or swabs). After use, tapped containers must be discarded.

Propofol-Lipuro 2 % (20 mg/ml) contains no antimicrobial preservatives and supports growth of microorganisms. Therefore, Propofol-Lipuro 2 % (20 mg/ml) is to be drawn up aseptically into a sterile syringe or an infusion set immediately after breaking the vial seal. Administration must commence without delay. Asepsis must be maintained for both Propofol-Lipuro 2 % (20 mg/ml) and the infusion equipment throughout the infusion period.

Any medicinal products or fluids added to a running Propofol-Lipuro 2 % (20 mg/ml) infusion must be administered close to the cannula site. Propofol-Lipuro 2 % (20 mg/ml) must not be administered via infusion sets with microbiological filters.

The contents of one vial of Propofol-Lipuro 2 % (20 mg/ml) and any syringe containing Propofol- Lipuro 2 % (20 mg/ml) are for single use in one patient. Any portion of the contents remaining after use must be discarded.

For administration of Propofol-Lipuro 2% by continuous infusion, it is recommended that burettes, drop counters, syringe pumps or volumetric infusion pumps should always be used to control the infu- sion rates. As established for the parenteral administration of all kinds of fat emulsions, the duration of continuous infusion of Propofol-Lipuro 2 % (20 mg/ml) from one infusion system must not exceed 12 hours. The infusion line and the reservoir of Propofol-Lipuro 2 % (20 mg/ml) must be discarded and replaced after 12 hours at the latest. Any portion of Propofol-Lipuro 2 % (20 mg/ml) remaining after the end of infusion or after replacement of the infusion system must be discarded.

This medicinal product must not be mixed with other medicinal products, but may be co-administered with those mentioned in section 6.6.
In order to reduce pain on initial injection of Propofol-Lipuro 2% for induction of general anaesthesia, lidocaine may be injected immediately prior to the injection of Propofol-Lipuro 2%.

Before giving the muscle relaxants atracurium or mivacurium subsequent to Propofol-Lipuro 2% through the same intravenous line, the line should be rinsed prior to administration.
Propofol may also be used by Target Controlled Infusion. Due to the different algorithms available on the market for dosage recommendations please refer to the instructions for use leaflet of the device manufacturer.

●     Duration of administration

Propofol-Lipuro 2% can be administered for a maximum period of 7 days.