ANESTICAP 1% MCT/LCT must only be given in hospitals or adequately equipped therapy units by physicians trained in anesthesia 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 ANESTICAP 1% MCT/LCT should not be administered by the same person conducting the surgical or diagnostic procedure.
The dose of ANESTICAP 1% MCT/LCT emulsion should be individualized based on the response of the patient and premedications used.
Supplementary analgesic agents are generally required in addition to ANESTICAP 1% MCT/LCT.
Adults: General anesthesia: Induction of anesthesia: For induction of anesthesia ANESTICAP 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 anesthesia.
Most adult patients aged less than 55 years are likely to require 40 mg every 10 seconds until induction onset (2 to 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 ANESTICAP 1% MCT/LCT may be reduced to a minimum of 1 mg Propofol/kg body weight. Lower rates of administration of ANESTICAP 1% MCT/LCT should be used approximately 2 mL (20 mg Propofol) every 10 seconds.
Maintenance of anesthesia: Anesthesia can be maintained by administering ANESTICAP 1% MCT/LCT either by continuous infusion or repeat bolus injections.
For maintenance of anesthesia generally doses of 4 to 12 mg Propofol/kg body weight/hour should be given. A reduced maintenance dose of approximately 4 mg Propofol/kg body weight/hour 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 ANESTICAP 1% MCT/LCT may be reduced further depending on the severity of the patient's condition and on the performed anesthetic technique.
The recommended reduction of the dosage of ANESTICAP 1% MCT/LCT is 3 to 6 mg Propofol/kg body weight/hour.
For maintenance of anesthesia using repeat bolus injections dose increments of 25 to 50 mg Propofol (= 2.5 - 5 mL ANESTICAP 1% MCT/LCT) should be given according to clinical requirements.
Sedation during intensive care: When used to provide sedation for ventilated patients under intensive care conditions, it is recommended that ANESTICAP 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/hour. Rates of infusion greater than 4.0 mg Propofol/kg body weight/hour are not recommended (see PRECAUTIONS).
Children over 3 years of age: General anesthesia: Due to lack of experience, ANESTICAP 1% MCT/LCT must not be used in children under 3 years of age.
Induction of anesthesia: When used to induce anesthesia, it is recommended that ANESTICAP 1% MCT/LCT should be titrated slowly until the clinical signs show the onset of anesthesia.
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 anesthesia. Under this age the dose requirement may be higher.
No experience is available in children of ASA grades III and IV.
Maintenance of anesthesia: For maintenance of anesthesia using continuous infusion doses of 9 to 15 mg Propofol/kg body weight/hour should be given.
Sedation during intensive care: Propofol must not be used for sedation in intensive care of patients of 16 years of age or younger (see CONTRAINDICATIONS).
If the patient is receiving other intravenous lipids concurrently, the amount of fat infused as part of the ANESTICAP 1% MCT/LCT formulation should be taken into account: 1.0 mL ANESTICAP 1% MCT/LCT contains 0.1 g of fat.
Method of Administration: The administration of the emulsion must be commence without delay after opening the ampoule. Aseptic must be maintained for both ANESTICAP 1% MCT/LCT and infusion equipment throughout the infusion period. Co-administration of other drugs or fluids added to the ANESTICAP 1% MCT/LCT infusion line must occur close to the cannula site. ANESTICAP 1% MCT/LCT must not be administered via a microbiological filter.
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