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  • Propofol – Lipuro 1%
    / Lapidot


    Active Ingredient
    Propofol 10 mg/ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Ampoule

    5 X 20 ml

    not in the basket chart 78927 16799

    Vial

    20 ml

    not in the basket chart

    Related information


    Dosage

    Propofol-Lipuro 1% 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% 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/kg body weight.
    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 1% 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 anaesthesia: Anaesthesia can be maintained by administering Propofol-Lipuro 1% either by continuous infusion or by repeat bolus injections. If a technique involving repeat bolus injections is used, increments of 25 mg (2.5 ml Propofol-Lipuro 1% to 50 mg (5.0 ml Propofol-Lipuro 1% 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 of age
    Induction of anaesthesia: For induction of anaesthesia Propofol-Lipuro 1% 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 1% 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 prescribing information for full details.


    Indications

    Propofol is a short-acting intravenous anaesthetic agent suitable for induction and maintenance of general anaesthesia in adults. Propofol may also be used for sedation of ventilated adult patients in intensive care and for anaesthesia in pediatric surgery (for children of 3 years of age or older) for surgical procedures which do not exceed 1 hour in duration. Propofol may also be used for conscious sedation for surgical and diagnostic procedures.


    Contra-Indications

    Hypersensitivity to propofol or to one of the excipients or fat emulsions, children under 16 years for sedation, high doses during pregnancy, and obstetric anesthesia with the exception of termination of pregnancy. Children under 3 years for induction of anesthesia.


    Special Precautions

    Propofol should be given by those trained in anaesthesia (or, where appropriate, doctors trained in the care of patients in Intensive Care).
    Patients should be constantly monitored and facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment and other resuscitative facilities should be readily available at all times. Propofol should not be administered by the person conducting the diagnostic or surgical procedure.
    The abuse of and dependence on propofol, predominantly by health care professionals, have been reported.
    As with other general anaesthetics, the administration of propofol without airway care may result in fatal respiratory complications.
    When propofol is administered for conscious sedation, for surgical and diagnostic procedures, patients should be continually monitored for early signs of hypotension, airway obstruction and oxygen desaturation.
    As with other sedative agents, when propofol is used for sedation during operative procedures, involuntary patient movements may occur. During procedures requiring immobility these movements may be hazardous to the operative site.
    An adequate period is needed prior to discharge of the patient to ensure full recovery after use of propofol. Very rarely the use of propofol may be associated with the development of a period of postoperative unconsciousness, which may be accompanied by an increase in muscle tone. This may or may not be preceded by a period of wakefulness. Although recovery is spontaneous, appropriate care of an unconscious patient should be administered.
    Propofol induced impairment is not generally detectable beyond 12 hours. The effects of propofol, the procedure, concomitant medications, the age and the condition of the patient should be considered when advising patients on:
    – The advisability of being accompanied on leaving the place of administration
    – The timing of recommencement of skilled or hazardous tasks such as driving
    – The use of other agents that may sedate (e.g. benzodiazepines, opiates, alcohol.)
    As with other intravenous anaesthetic agents, caution should be applied in patients with cardiac, respiratory, renal or hepatic impairment or in hypovolaemic or debilitated patients.
    Propofol clearance is blood flow dependent, therefore, concomitant medication that reduces cardiac output will also reduce propofol clearance.
    See prescribing information for full details.


    Side Effects

    Metabolism and nutrition disorders: Common: Hypertriglyceridemia.
    Nervous system disorders: Common: During induction of anaesthesia spontaneous movements and myocloni, minimal excitation.
    Cardiac disorders / Vascular disorders: Common: During induction of anaesthesia, hypotension, bradycardia, tachycardia, hot flushes.
    Respiratory, thoracic and mediastinal disorders: Common: During induction of anaesthesia hyperventilation, transient apnoea, coughing, singultus.
    For full details see prescribing information.


    Drug interactions

    Propofol has been used in association with spinal and epidural anaesthesia and with commonly used premedicants, neuromuscular blocking drugs, inhalational agents and analgesic agents; no pharmacological incompatibility has been encountered. Lower doses of propofol may be required where general anaesthesia or sedation is used as an adjunct to regional anaesthetic techniques.
    Profound hypotension has been reported following anaesthetic induction with propofol in patients treated with rifampicin.
    The concurrent administration of other CNS depressants such as pre-medication drugs, inhalation agents, analgesic agents may add to the sedative, anaesthetic and cardiorespiratory depressant effects of propofol.
    A need for lower propofol doses has been observed in patients taking valproate.
    When used concomitantly, a dose reduction of propofol may be considered.


    Pregnancy and Lactation

    Pregnancy: The safety of propofol during pregnancy has not been established. Propofol should not be given to pregnant women except when absolutely necessary. Propofol can, however, be used during an induced abortion.
    Obstetrics propofol crosses the placenta and can cause neonatal depression. It should not be used for obstetric anaesthesia unless clearly necessary.
    Breast-feeding: Studies of breast-feeding mothers showed that small quantities of propofol are excreted in human milk. Women should therefore not breastfeed for 24 hours after administration of propofol. Milk produced during this period should be discarded.


    Overdose

    Accidental overdose is likely to cause cardiorespiratory depression.
    Respiratory depression should be treated by artificial ventilation with oxygen. Cardiovascular depression may require lowering the patient’s head and if severe, use of plasma expanders and pressor agents.


    Manufacturer
    B. Braun Melsungen AG
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