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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 oximetry), and facilities for maintenance of patent 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 to 2.5 mg propofol/kg bodyweight.
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 bodyweight. Lower rates of administration of Fresofol 1% MCT/LCT should be used (approximately 2 ml of the 10 mg/ml emulsion (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 bodyweight/h should be given. A reduced maintenance dose of approximately 4 mg propofol/kg bodyweight/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 with Fresofol 1% MCT/LCT using repeat bolus injections, dose increments of 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) with Fresofol 1% MCT/LCT should not be used in the elderly as this may lead to cardiopulmonary depression.
General anaesthesia in children over 1 month of age: Induction of anaesthesia: For induction of anaesthesia, Fresofol 1% MCT/LCT 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 propofol/kg bodyweight Fresofol 1% MCT/LCT for induction of anaesthesia. In younger children, especially between the age of 1 month and 3 years, dose requirements may be higher (2.5 - 4 mg/kg bodyweight).
Maintenance of general anaesthesia: Anaesthesia can be maintained by administering Fresofol 1% MCT/LCT 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 III and IV patients, lower doses are recommended (see also Precautions).
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 Fresofol 1% MCT/LCT 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 (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.
Sedation for diagnostic and surgical procedures 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 bodyweight propofol 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 require 1.5 - 9 mg/kg/h propofol. With Fresofol 1% MCT/LCT, the infusion may be supplemented by bolus administration of up to 1 mg/kg bodyweight if a rapid increase of depth of sedation is required.
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 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 bodyweight/h. Rates of infusion greater than 4.0 mg propofol/kg bodyweight/h are not recommended (see Precautions).
Administration of propofol by a target controlled infusion (TCI) system is not advised for sedation in the intensive care unit (ICU).
Duration of administration: The duration of administration must not exceed 7 days.
Method of administration: For intravenous use. For single use only. Any unused emulsion must be discarded.
Containers should be shaken before use. If two layers can be seen after shaking, the emulsion should not be used. Use only homogeneous preparations and undamaged containers.
Fresofol 1% MCT/LCT can be used for infusion undiluted or diluted (for dilution, see Pharmaceutical precautions under Cautions for Usage).
When Fresofol 1% MCT/LCT is infused, it is recommended that equipment such as burettes, drop counter, syringe pumps (including TCI systems) or volumetric infusion pumps should always be used to control infusion rates.
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 and 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. For instructions on co-administration of the medicinal product, see Pharmaceutical precautions under Cautions for Usage.
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: As usual for fat emulsions, the infusion of undiluted 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 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.
To reduce pain on the injection site, lidocaine may be injected immediately before the use of Fresofol 1% MCT/LCT (see Precautions). Alternatively, 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.
If Fresofol 1% MCT/LCT is injected into a vein by electric pumps, appropriate compatibility should be ensured.
