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Fresofol 1% MCT/LCT must only be given in hospitals or adequately equipped day therapy units by physicians trained in anaesthesia or in the care of patients in intensive care.
Circulatory and respiratory functions should be constantly monitored (e.g. ECG, pulse oxymetry) and facilities for maintenance of patient airways, artificial ventilation and other resuscitation facilities should be immediately available at all times.
For sedation during surgical and diagnostic procedures, Fresofol 1% MCT/LCT should not be administered by the same person conducting the surgical or diagnostic procedure.
The dose of Fresofol 1% MCT/LCT emulsion should be individualised based on the response of the patient and premedications used.
Supplementary analgesic agents are generally required in addition to Fresofol 1% MCT/LCT.
Posology: General Anaesthesia in adults: Induction of anaesthesia: For induction of anaesthesia Fresofol 1% MCT/LCT should be titrated (approximately 20-40 mg propofol every 10 seconds) against the response of the patient until clinical signs show the onset of anaesthesia.
Most adult patients aged less than 55 years are likely to require 1.5-2.5 mg propofol/kg body weight.
In patients over this age and in patients of ASA grades III and IV, especially those with impaired cardiac function, the requirements will generally be less and the total dose of Fresofol 1% MCT/LCT may be reduced to a minimum of 1 mg propofol/kg body weight. Lower rates of administration of Fresofol 1% MCT/LCT should be used [approximately 2 ml (20 mg propofol) every 10 seconds].
Maintenance of anaesthesia: Anaesthesia can be maintained by administering Fresofol 1% MCT/LCT either by continuous infusion or repeat bolus injections.
For maintenance of anaesthesia generally doses of 4 to 12 mg propofol/kg body weight/h should be given. A reduced maintenance dose of approximately 4 mg propofol/kg body weight/h may be sufficient during less stressful surgical procedures such as minimal invasive surgery.
In elderly patients, patients in unstable general conditions, patients with impaired cardiac function or hypovolaemic patients and patients of ASA grades III and IV, the dosage of Fresofol 1% MCT/LCT may be reduced further depending on the severity of the patient's condition and on the performed anaesthetic technique.
For maintenance of anaesthesia using repeat bolus injections dose increments of propofol 25 to 50 mg propofol (=2.5-5 ml Fresofol 1% MCT/LCT) should be given according to clinical requirements.
Rapid bolus administration (single or repeated) should not be used in the elderly as this may lead to cardiopulmonary depression.
General anaesthesia in children over 1 month of age: Fresofol 1% MCT/LCT is not advised for general anaesthesia in children younger than 1 month of age.
Induction of anaesthesia: When used to induce anaesthesia, it is recommended that Fresofol 1% MCT/LCT should be titrated slowly until the clinical signs show the onset of anaesthesia.
The dose should be adjusted for age and/or body weight. Children over 8 years of age are likely to require approximately 2.5 mg propofol/kg body weight for induction of anaesthesia. Under this age the dose requirement may be higher.
The initial dose should be 3 mg propofol/kg body weight. If necessary, additional doses in steps of 1 mg propofol/kg body weight can be administered.
Lower dosages are recommended for young patients at increased risk (ASA grades III and IV).
Administration of propofol by a Target Controlled Infusion (TCI) system is not advised for induction of general anaesthesia in children.
Maintenance of anaesthesia: For maintenance of anaesthesia using continuous infusion, doses of 9 to 15 mg propofol/kg body weight/h should be given.
Younger children, less than 3 years, may need higher dosage requirements, within the range of recommended dosages, when compared with older paediatric patients.
There is no data on maintenance of anaesthesia with repeated injections of propofol in children.
Dosage should be adjusted individually and particular attention paid to the need for adequate analgesia.
A maximum duration of use of approximately 60 minutes should not be exceeded except where there is a specific indication for longer use e.g. malignant hyperthermia where volatile agents must be avoided.
Administration of propofol by a Target Controlled Infusion (TCI) system is not advised for maintenance of general anaesthesia in children.
Sedation in adults during intensive care: When used to provide sedation for ventilated patients under intensive care conditions, it is recommended that Fresofol 1% MCT/LCT 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 body weight/h. Rates of infusion greater than 4.0 mg propofol/kg body weight/h are not recommended (see Precautions).
Propofol must not be used for sedation in intensive care of patients of 16 years of age or younger (see Contraindications).
Administration of Fresofol 1% MCT/LCT by a Target Controlled Infusion (TCI) system is not advised for sedation in the Intensive Care Unit.
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 body weight over 1 to 5 minutes for onset of sedation. Maintenance of sedation may be accomplished by titrating Fresofol 1% MCT/LCT infusion to the desired level of sedation. Most patients will require 1.5-4.5 mg propofol/kg body weight/h. The infusion may be supplemented by bolus administration of 10-20 mg (1-2 ml Fresofol 1% MCT/LCT) 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 Fresofol 1% MCT/LCT may be required and the rate of administration may need to be reduced.
Propofol must not be used for sedation for diagnostic and surgical procedures in patients of 16 years of age or younger.
Method of Administration: For intravenous use.
Fresofol 1% MCT/LCT can be used for infusion undiluted or diluted with Dextrose 5% intravenous infusion solution or Sodium chloride 0.9% intravenous infusion solution only, in glass infusion bottles.
Containers should be shaken before use.
Use only homogenous preparations and undamaged containers.
Prior to use, the ampoule neck or rubber membrane should be cleaned using an alcohol spray or a swab dipped in alcohol. After use, tapped containers must be discarded.
Fresofol 1% MCT/LCT is a lipid containing emulsion without antimicrobial preservatives and may support rapid growth of microorganisms.
The emulsion must be drawn aseptically into a sterile syringe or giving set immediately after opening the ampoule or breaking the vial seal. Administration must commence without delay.
Asepsis must be maintained for both Fresofol 1% MCT/LCT and infusion equipment throughout the infusion period. Co-administration of other medicinal products or fluids added to the Fresofol 1% MCT/LCT infusion line must occur close to the cannula site using a Y-piece connector or a three-way valve.
Fresofol 1% MCT/LCT must not be mixed with other solutions for infusion or injection. But 5% w/v glucose solution, 0.9% w/v sodium chloride solution or 0.18% w/v sodium chloride and 4% w/v glucose solution may be administered via suitable appendages at the cannula site.
Fresofol 1% MCT/LCT must not be administered via a microbiological filter.
Fresofol 1% MCT/LCT and any infusion equipment containing Fresofol 1% MCT/LCT are for single administration in an individual patient. After use, remaining solution of Fresofol 1% MCT/LCT has to be discarded.
Infusion of undiluted Fresofol 1% MCT/LCT: When Fresofol 1% MCT/LCT is infused undiluted, it is recommended that equipment such as burettes, drop counter, syringe pumps or volumetric infusion pumps should always be used to control infusion rates.
As usual for fat emulsions, the infusion of Fresofol 1% MCT/LCT via one infusion system must not exceed 12 hours. After 12 hours, the infusion system and reservoir of Fresofol 1% MCT/LCT must be discarded or replaced if necessary.
Infusion of diluted Fresofol 1% MCT/LCT: For administering infusion of diluted Fresofol 1% MCT/LCT, burettes, drop counters or volumetric infusion pumps should always be used to control infusion rates and to avoid the risk of accidentally uncontrolled infusion of large volumes of diluted Fresofol 1% MCT/LCT. This risk has to be taken into account when the decision for the maximum dilution in the burette is made.
The maximum dilution must not exceed 1 part of Fresofol 1% MCT/LCT with 4 parts of 5% w/v glucose solution or 0.9% w/v sodium chloride solution (minimum concentration 2 mg propofol/ml). The mixture should be prepared aseptically (controlled and validated conditions preserved) immediately prior to administration and must be administered within 6 hours after preparation.
Fresofol 1% MCT/LCT must not be mixed with other solutions for infusion or injection. However, co-administration of a 5% w/v glucose solution or 0.9% w/v sodium chloride solution or 0.18% w/v sodium chloride and 4% w/v glucose solution with Fresofol 1% MCT/LCT is permitted via a Y-piece connector close to the injection site.
To reduce pain on the injection site, lidocaine may be injected immediately before the use of Fresofol 1% MCT/LCT or Fresofol 1% MCT/LCT may be mixed, immediately for use with preservative-free lidocaine injection (20 parts of Fresofol 1% MCT/LCT with up to 1 part of 1% lidocaine injection solution) under controlled and validated aseptical conditions. The mixture has to be administered within 6 hours after preparation.
Muscle relaxants like atracurium and mivacurium should only be administered after flush of the same infusion site used for Fresofol 1% MCT/LCT.
Duration of administration: The duration of administration must not exceed 7 days.
