PROPOFOL-LIPURO INJECTION 1% w/v

EMULSION

**Dosage** _General instructions_ Propofol-®Lipuro 1 % (10 mg/ml) 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-oxymeter) and facilities for maintenance of patent airways, artificial ventilation, and other resuscitation facilities should always be immediately available. For sedation during surgical or diagnostic procedures Propofol-®Lipuro 1 % (10 mg/ml) should not be given by the same person that carries out the surgical or diagnostic procedure. Supplementary analgesic drugs are generally required in addition to Propofol-®Lipuro 1 % (10 mg/ml). Propofol-®Lipuro 1 % (10 mg/ml) is given intravenously. The dosage is adjusted individually according to the patient’s response. _General anaesthesia in adults_ Induction of anaesthesia: For induction of anaesthesia Propofol-®Lipuro 1 % (10 mg/ml) should be titrated (20 – 40 mg 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 BW (body weight). 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 1 % (10 mg/ml) may be reduced to a minimum of 1 mg of propofol/kg BW. In these patients lower rates of administration should be applied (approximately 2 ml, corresponding to 20 mg, every 10 seconds). Maintenance of anaesthesia: Anaesthesia can be maintained by administering Propofol-®Lipuro 1 % (10 mg/ml) either by continuous infusion or by repeat bolus injections. If a technique involving repeat bolus injections is used, increments of 25 – 50 mg of propofol (2.5 – 5.0 ml Propofol-®Lipuro 1 % (10 mg/ml)) may be given according to clinical requirements. For maintenance of anaesthesia by continuous infusion the dosage requirements usually are in the range of 6 – 12 mg/kg BW/h. In the elderly, in patients of poor general condition, in patients of ASA grade 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 3 years_ Induction of anaesthesia: For induction of anaesthesia Propofol-®Lipuro 1 % (10 mg/ml) should be titrated slowly against the response of the patient 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 are likely to require approximately 2.5 mg of propofol/kg BW for induction of anaesthesia. Below this age the dose requirement may be higher (2.5 – 4 mg/kg). Due to the lack of clinical experience, lower dosages are recommended for young patients at increased risk (ASA grades III and IV). Maintenance of general anaesthesia: For maintenance of general anaesthesia, a satisfactory level of anaesthesia is usually achieved by continuous infusion with a dosage regimen in the range of 9 – 15 mg of propofol/kg BW/h. Dosage should be adjusted individually and particular attention paid to the need for adequate analgesia (see also section “General instructions” above). Propofol-®Lipuro 1 % (10 mg/ml) must not be used for induction and maintenance of anaesthesia in children younger than 3 years. _Sedation of adults during intensive care_ When used to provide sedation for ventilated patients under intensive care conditions, it is recommended that Propofol-®Lipuro 1 % (10 mg/ml) be given by continuous infusion. The infusion rate should be adjusted according to the required depth of sedation. Usually satisfactory sedation is achieved with administration rates in the range of 0.3 – 4.0 mg of propofol/kg BW/h. (See also section “Special warnings and precautions for use” – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Propofol-®Lipuro 1 % (10 mg/ml) must not be used for sedation in children younger than 16 years. _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 of propofol/kg BW over 1 to 5 minutes for onset of sedation. Maintenance of sedation may be accomplished by titrating Propofol-®Lipuro 1 % (10 mg/ml) infusion to the desired level of sedation. Most patients will require 1.5 – 4.5 mg of propofol/kg BW/h. The infusion may be supplemented by bolus administration of 10 – 20 mg of propofol (1 – 2 ml Propofol-®Lipuro 1 % (10 mg/ml)) 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 1 % (10 mg/ml) may be required and the rate of administration may need to be reduced. Propofol-®Lipuro 1 % (10 mg/ml) must not be used for sedation for diagnostic and surgical procedures in patients of 16 years or younger. _Method of administration_ Propofol-®Lipuro 1 % (10 mg/ml) 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 as well as in a 0.18 % w/v sodium chloride and 4 % w/v glucose solution in PVC infusion bags or glass infusion bottles. Containers should be shaken before use. Before use, the neck of the ampoule or the surface of the rubber stopper of the bottle should be cleaned with medicinal alcohol (spray or swabs). After use, tapped containers must be discarded. Propofol-®Lipuro 1 % (10 mg/ml) contains no antimicrobial preservatives and supports growth of microorganisms. Therefore, Propofol-®Lipuro 1 % (10 mg/ml) is to be drawn up aseptically into a sterile syringe or an infusion set immediately after opening the ampoule or breaking the bottle seal. Administration must commence without delay. Asepsis must be maintained for both Propofol-®Lipuro 1 % (10 mg/ml) and the infusion equipment throughout the infusion period. Any drugs or fluids added to a running Propofol-®Lipuro 1 % (10 mg/ ml) infusion must be administered close to the cannula site. Propofol-®Lipuro 1 % (10 mg/ml) must not be administered via infusion sets with microbiological filters. The contents of one ampoule or one bottle of Propofol-®Lipuro 1 % (10 mg/ml) and any syringe containing Propofol-®Lipuro 1 % (10 mg/ml) are for single use in one patient. Any portion of the contents remaining after use must be discarded. Infusion of undiluted Propofol-®Lipuro 1 % (10 mg/ml) When administering Propofol-®Lipuro 1 % (10 mg/ml) 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 1 % (10 mg/ml) from one infusion system must not exceed 12 hours. The infusion line and the reservoir of Propofol-®Lipuro 1 % (10 mg/ml) must be discarded and replaced after 12 hours at the latest. Any portion of Propofol-®Lipuro 1 % (10 mg/ml) remaining after the end of infusion or after replacement of the infusion system must be discarded. Infusion of diluted Propofol-®Lipuro 1 % (10 mg/ml) For administering infusion of diluted Propofol-®Lipuro 1 % (10 mg/ml), 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 1 % (10 mg/ml). The maximum dilution must not exceed 1 part of Propofol-®Lipuro 1 % (10 mg/ml) with 4 parts of 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 (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. Propofol-®Lipuro 1 % (10 mg/ml) must not be mixed with other solutions for injection or infusion. Co-administration of Propofol-®Lipuro 1 % (10 mg/ml) together with 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 via a Y-connector close to the injection site is possible. In order to reduce pain on initial injection, Propofol-®Lipuro 1 % (10 mg/ml) may be mixed with preservative-free lidocaine injection 1 % (mix 20 parts of Propofol-®Lipuro 1 % (10 mg/ml) with up to 1 part of lidocaine injection 1 %). Before giving the muscle relaxants atracurium or mivacurium subsequent to Propofol-®Lipuro 1 % (10 mg/ml) through the same intravenous line, it is recommended that the line be rinsed prior to administration. _Duration of use_ Propofol-®Lipuro 1 % (10 mg/ml) can be administered for a maximum period of 7 days.