BAXTER PROPOFOL MCT-LCT EMULSION FOR INJECTION OR INFUSION 1% W/V [SIN17047P]

Product Info

BAXTER PROPOFOL MCT-LCT EMULSION FOR INJECTION OR INFUSION 1% W/V

[SIN17047P]

Therapeutic Indications

• maintenance of general anaesthesia in adults and children > 3 years of age

• induction of general anaesthesia in adults and children > 1 month of age

• sedation for diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia in adults and children > 16 years

• sedation of ventilated patients >16 years of age in the intensive care unit.

Posology and method of administration
Usual equipment must be available for the eventuality of incidents whilst under anaesthesia. The cardiovascular system must be monitored (e.g. ECG, pulse oxymetry).
The dose of Propofol 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 Propofol 1% MCT/LCT.

Posology
Anaesthesia in adults
Induction of anaesthesia:
For induction of anaesthesia Propofol 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 body weight.
Over this age, the requirement will be generally less. In patients of ASA grades III and IV the requirements will generally be less and induction should be performed more slowly. Lower rates of administration of Propofol 1 % MCT/LCT should be used (approximately 2ml (20mg) propofol every 10 seconds).

Maintenance of anaesthesia:
Anaesthesia can be maintained by administering Propofol 1 % MCT/ LCT either by continuous infusion or repeat bolus injections.
For maintenance of anaesthesia using continuous infusion, 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 or hypovolaemic patients and patients of ASA grades III and IV, a reduction of the dosage of Propofol 1% MCT/LCT to 4 mg propofol/kg body weight/h is recommended.
For maintenance of anaesthesia using repeat bolus injections, dose increments of 25 to 50 mg propofol (=2.5 – 5 ml Propofol 1% MCT/ LCT) should be given.

General anaesthesia in children
Induction of anaesthesia:
For induction of anaesthesia Propofol 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/ kg body weight Propofol 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 body weight).

Maintenance of general anaesthesia:
Anaesthesia can be maintained by administering Propofol 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.
Due to the lack of clinical experience, lower dosages are recommended for young patients at increased risk (ASA grades III and IV).
Propofol 1% MCT/LCT should not be used in children < 3 years of age for the maintenance of general anaesthesia.

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 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 Propofol 1% (10 mg/1 ml) 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 Propofol 1 % MCT/LCT may be required and the rate of administration may need to be reduced.
Propofol 1% MCT/LCT must not be used for sedation for diagnostic and surgical procedures in patients of 16 years of age or younger.

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 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 section Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Administration of Propofol MCT/LCT by a target-controlled infusion (TCI) system is not advised for sedation in the intensive care unit (ICU).

Advisory statements concerning intensive care unit management
Use of propofol emulsion infusion for ICU sedation has been associated with constellation of metabolic derangements and organ system failures that may result in death.
Reports have been received of combinations of the following: Metabolic acidosis, Rhabdomyolysis, Hyperkalaemia, Hepatomegaly, Renal failure, Hyperlipidemia, Cardiac arrhythmia, Brugada-type ECG (Elevated ST-segment and covered T-wave) and rapidly progressive cardiac failure usually unresponsive to inotropic supportive treatment. Combinations of these events have been referred to as the Propofol infusion syndrome. These events were mostly seen in patients with serious head injuries and children with respiratory tract infections who received dosages in excess of those advised in adults for sedation in the intensive care unit.
The following appear to be the major risk factor for the development of these events: decreased oxygen delivery to tissues; serious neurological injury and /or sepsis; high dosages of one or more of the following pharmacological agents–vasoconstrictors, steroid, inotropes and/or Propofol (usually at dose rates greater than 4 mg/kg/h for more than 48 hours).
Prescribers should be alert to these events in patients with the above risk factors and immediately discontinue Propofol when the above signs develop. All sedative and therapeutic agents used in the intensive care unit (ICU), should be titrated to maintain optimal oxygen delivery and haemodynamic parameters. Patients with raised intra-cranial pressure (ICP), should be given appropriate treatment to support the cerebral perfusion pressure during these treatment modifications.

Method of administration
Propofol 1% MCT/LCT can be used for infusion undiluted or diluted with Dextrose 5% intravenous infusion solution or Sodium chloride 0.9 % intravenous infusion only, in glass infusion bottles.
Containers should be shaken before use.
Propofol 1% MCT/LCT is a lipid containing emulsion without antimicrobial preservatives and may support rapid growth of micro-organisms.
Use only homogeneous 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.
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 Propofol 1% MCT/LCT and infusion equipment throughout the infusion period. Co-administration of other drugs or fluid added to the Propofol 1% MCT/LCT infusion line must occur close to the cannula site. Propofol 1% MCT/LCT must not be administered via a microbiological filter.
Propofol 1% MCT/LCT and any infusion equipment containing Propofol 1 % MCT/LCT are for single administration in an individual patient.

Infusion of undiluted Propofol 1% MCT/LCT
When Propofol 1% MCT/LCT is infused undiluted, it is recommended that equipment such as drop counter, syringe pumps or volumetric infusion pumps should always be used to control infusion rates.
As usual for fat emulsion, the infusion of Propofol 1% MCT/LCT via one infusion system must not exceed 12 hours. After 12 hours, the infusion system and reservoir of Propofol 1% MCT/LCT must be discarded or replaced if necessary.

Infusion of diluted Propofol 1% MCT/LCT
The dilution may be used with a variety of infusion control techniques, but a giving set used alone will not avoid the risk of accidental uncontrolled infusion of large volumes of diluted Propofol 1% MCT/LCT. A burette, drop counter or volumetric pump must be included in the infusion line.
The risk must be taken into account when deciding the maximum dilution in the burette.
Dilutions, which must not exceed 1 part of Propofol 1% MCT/LCT and 4 part of Dextrose 5% intravenous infusion solution or Sodium Chloride 0.9% intravenous infusion solution (at least 2 mg Propofol per ml) should be prepared aseptically immediately before administration and must be administered within 6 hours after preparation.

Incompatibilities
Propofol 1% MCT/LCT must not be diluted with other solution for infusion or injection. Co-administration of a Dextrose 5%, Sodium Chloride 0.9 % or Dextrose/Sodium chloride intravenous infusion solution with Propofol 1% MCT/LCT is permitted via a Y-piece connector close to the injection site.
To reduce pain on the injection site, Propofol 1% MCT/LCT may be mixed, immediately for use, with preservative free Lidocaine injection 1% (20 parts of Propofol 1% MCT/LCT with up to 1 part of 1% Lidocaine Injection Solution).
Muscle relaxants like atracurium and mivacurium should only be administered after flush of the same infusion site used for Propofol 1% MCT/LCT.

Duration of administration
The duration of administration must not exceed 7 days.

Contraindications
Hypersensitivity to Propofol or to one of the excipients.
Propofol 1 % MCT/LCT must not be used during pregnancy, breast-feeding and obstetrics (except abortion).
For sedation of children less than 16 years of age in the Intensive Care Unit.