Content: Propofol.
Decription:
1 ml of emulsion contains 10 mg of propofol.
Propofol-Lipuro 200 mg/20 mL ampoule: One ampoule of 20 ml contains 200 mg of propofol.
Excipients/Inactive Ingredients: Refined soya-bean oil 50 mg/ml, medium-chain triglycerides, glycerol, egg lecithin, sodium oleate, equivalent to 0.03 mg sodium/ml, water for injections.
Propofol-Lipuro 500 mg/50 mL vial: One vial of 50 ml contains 500 mg of propofol.
Excipients with known effect: 1 ml of emulsion for injection or infusion contains soya-bean oil, refined 50 mg; sodium 0.03 mg.
Excipients/Inactive Ingredients: Refined soya-bean oil, medium-chain triglycerides, glycerol, egg lecithin, sodium oleate, water for injections.
Indication: PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION is a short-acting intravenous general anaesthetic indicated for: induction and maintenance of general anaesthesia in adults and children > 1 month; sedation of ventilated patients >16 years of age in the intensive care unit; sedation for diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia in adults and children > 1 month
Dosage:
General instructions: PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION should 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-oxymeter) and facilities for maintenance of patent airways, artificial ventilation, and other resuscitation facilities should always be immediately available at all times. For sedation during surgical or diagnostic procedures PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION should not be given by the same person that carries out the surgical or diagnostic procedure.
Propofol is contraindicated in patients of 16 years of age or younger for sedation for intensive care (see Contraindications). Safety and efficacy for these age groups have not been demonstrated.
Supplementary analgesic medicinal products are generally required in addition to PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION.
Posology: PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION is given intravenously. The dosage is adjusted individually according to the patient's response.
General anaesthesia in adults: Induction of general anaesthesia: For induction of anaesthesia PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION should be titrated (20 - 40 mg of 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 of propofol/kg body weight.
Propofol-Lipuro 200 mg/20 mL ampoule: In older patients and in patients of ASA grades III and IV, especially those with impaired cardiac function, the dosage requirements will be less and the total dose of Propofol-Lipuro 10 mg/ml may be reduced to 1 mg/kg body weight or less. In these patients lower rates of administration should be applied (approximately 2 ml, corresponding to 20 mg, every 10 seconds).
Propofol-Lipuro 500 mg/50 mL vial: In patients over this age and in patients of ASA grades III and IV, especially those with impaired cardiac function, the dosage requirements will be less and the total dose of PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION 500MG/50ML may be reduced to a minimum of 1 mg/kg body weight. In these patients lower rates of administration should be applied (approximately 2 ml, corresponding to 20 mg every 10 seconds).
Maintenance of general anaesthesia: Anaesthesia can be maintained by administering PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION either by continuous infusion or by repeat bolus injections. If a technique involving repeat bolus injections is used, increments of 25 - 50 mg (2.5 - 5.0 ml PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION) may be given according to clinical requirements. For maintenance of anaesthesia by continuous infusion the dosage requirements usually are in the range of 4 - 12 mg/kg body weight/h.
In elderly patients, in patients of poor general condition, in patients of ASA grades III and IV and in hypovolaemic patients the dosage may be reduced further depending on the severity of the patient's condition and on the performed anaesthetic technique.
General anaesthesia in children over 1 month: Induction of anaesthesia: For induction of anaesthesia PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION should be slowly titrated against the patient's response 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 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-LIPURO EMULSION FOR INJECTION/INFUSION 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 of ventilated patients in the Intensive Care Unit: For sedation during intensive care it is advised that propofol 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 mg/kg/h of propofol (see also Precautions).
Propofol is not indicated for sedation in intensive care of patients of 16 years of age or younger (see Contraindications).
Administration of propofol by Target Controlled Infusion (TCI) system is not advised for sedation in the intensive care unit.
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 EMULSION FOR INJECTION/INFUSION infusion to the desired level of sedation. Most patients will require 1.5 - 4.5 mg/kg body weight/h. The infusion may be supplemented by bolus administration of 10 - 20 mg (1 - 2 ml PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION) if a rapid increase of the depth of sedation is required.
In patients older than 55 years and in patients of ASA grade III and IV lower doses of PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION may be required and the rate of administration may need to be reduced.
Sedation for diagnostic and surgical procedures in children over 1 month: 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 PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION as infusion to the desired level of sedation. Most patients require 1.5 - 9 mg/kg/h of propofol. The infusion may be supplemented by bolus administration of up to 1 mg/kg b.w. if a rapid increase of depth of sedation is required.
In ASA III and IV patients lower doses may be required.
Method and duration of administration: Method of administration: Intravenous use.
PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION is administered intravenously by injection or continuous infusion either undiluted or diluted with 5 % w/v glucose solution or 0.9 % w/v sodium chloride solution (for Propofol-Lipuro 200 mg/20 mL ampoule and Propofol-Lipuro 500 mg/50 mL vial) as well as in a 0.18 % w/v sodium chloride and 4 % w/v glucose solution (for Propofol-Lipuro 200 mg/20 mL ampoule) (see also Special precautions for disposal and other handlings under Cautions for Usage).
Containers should be shaken before use.
Before use, the neck of the ampoule or 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 EMULSION FOR INJECTION/INFUSION contains no antimicrobial preservatives and supports growth of microorganisms. Therefore, PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION is to be drawn up aseptically into a sterile syringe or an infusion set immediately after opening the ampoule or breaking the vial seal. Administration must commence without delay. Asepsis must be maintained for both PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION and the infusion equipment throughout the infusion period.
Any medicinal products or fluids added to a running PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION infusion must be administered close to the cannula site. Propofol must not be administered via infusion sets with microbiological filters. If infusion sets with filters are to be used, these must be lipid-permeable.
The contents of one ampoule or one vial of PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION and any syringe containing PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION are for single use in one patient.
Infusion of undiluted PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION: When administering PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION by continuous infusion, it is recommended that burettes, drop counters, syringe pumps or volumetric infusion pumps, should always be used to control the infusion rates. As established for the parenteral administration of all kinds of fat emulsions, the duration of continuous infusion of PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION from one infusion system must not exceed 12 hours. The infusion line and the reservoir of PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION must be discarded and replaced after 12 hours at the latest. Any portion of PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION remaining after the end of administration or after replacement of the infusion system must be discarded.
Infusion of diluted PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION: For administering infusion of diluted PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION, burettes, drop counters, syringe pumps, 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 PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION.
The maximum dilution must not exceed 1 part of PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION with 4 parts of 5 % w/v glucose solution or 0.9 % w/v sodium chloride solution (for Propofol-Lipuro 200 mg/20 mL ampoule and Propofol-Lipuro 500 mg/50 mL vial), or 0.18 % w/v sodium chloride and 4 % w/v glucose solution (for Propofol-Lipuro 200 mg/20 mL ampoule) (minimum concentration 2 mg propofol/ml). The mixture should be prepared aseptically immediately prior to administration and must be used within 6 hours of preparation.
In order to reduce pain on initial injection, PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION may be mixed with preservative-free lidocaine injection 1 % (mix 20 parts of PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION with up to 1 part of lidocaine injection 1 %).
Before giving the muscle relaxants atracurium or mivacurium subsequent to PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION through the same intravenous line, it is recommended that the line 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.
This medicinal product must not be mixed with other medicinal products except those mentioned in Special precautions for disposal and other handlings under Cautions for Usage.
Duration of administration: PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION can be administered for a maximum period of 7 days.
