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  • Remifentanil Teva
    / Abic


    Active Ingredient
    Remifentanil HCl 1, 2, 5 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    5 X 1 mg

    not in the basket chart 76446 18522

    Vial

    5 X 2 mg

    not in the basket chart 76447 18523

    Vial

    5 X 5 mg

    not in the basket chart 76448 18524

    Related information


    Dosage

    It should be administered only in a setting fully equipped for the monitoring and support of respiratory and cardiovascular function and by persons specifically trained in the use of anaesthetic drugs and the recognition and management of the expected adverse effects of potent opioids, including respiratory and cardiac resuscitation. Such training must include the establishment and maintenance of a patent airway and assisted ventilation. It is for intravenous use only and must not be administered by epidural or intrathecal injection.
    Dilution: See prescribing information for full details.
    General Anaesthesia: The administration of this product must be individualised based on the patient’s response. For specific dosing guidelines for patients undergoing cardiac surgery see prescribing information for full details.
    Adults: Administration by Manually-Controlled Infusion: See prescribing information for full details.
    Induction of anaesthesia: This product should be administered with a standard dose of a hypnotic agent, such as propofol, thiopentone, or isoflurane, for the induction of anaesthesia. Administering this product after an hypnotic agent will reduce the incidence of muscle rigidity. It can be administered at an infusion rate of 0.5 to 1 micrograms/kg/min, with or without an initial slow bolus injection of 1 microgram/kg given over not less than 30 seconds. If endotracheal intubation is to occur more than 8 to 10 minutes after the start of the infusion of this product, then a bolus injection is not necessary.
    Maintenance of anaesthesia in ventilated patients: After endotracheal intubation, the infusion rate should be decreased, according to anaesthetic technique, as indicated in prescribing information. Due to the fast onset and short duration of action of this product, the rate of administration during anaesthesia can be titrated upward in 25% to 100% increments or downward in 25% to 50% decrements, every 2 to 5 minutes to attain the desired level of μ-opioid response. In response to light anaesthesia, supplemental slow bolus injections may be administered every 2 to 5 minutes.
    Anaesthesia in spontaneously breathing anaesthetised patients with a secured airway (e.g. laryngeal mask anaesthesia): In spontaneously breathing anaesthetised patients with a secured airway respiratory depression is likely to occur. Special care is needed to adjust the dose to the patient requirements and ventilatory support may be required. The recommended starting infusion rate for supplemental analgesia in spontaneously breathing anaesthetised patients is 0.04 micrograms/kg/min with titration to effect. A range of infusion rates from 0.025 to 0.1 micrograms/kg/min has been studied. Bolus injections are not recommended in spontaneously breathing anaesthetised patients. This product should not be used as an analgesic in procedures where patients remain conscious or do not receive any airway support during the procedure.
    Concomitant medication: This product decreases the amounts or doses of inhaled anaesthetics, hypnotics and benzodiazepines required for anaesthesia. Doses of the following agents used in anaesthesia: isoflurane, thiopentone, propofol and temazepam have been reduced by up to 75% when used concurrently with remifentanil.
    Guidelines for discontinuation/continuation into the immediate post-operative period: See prescribing information for full details.
    Cardiac anaesthesia: Administration by Manually-Controlled Infusion: See prescribing information for full details.
    Induction period of anaesthesia: After administration of hypnotic to achieve loss of consciousness, this product should be administered at an initial infusion rate of 1 microgram/kg/min. The use of bolus injections of this product during induction in cardiac surgical patients is not recommended. Endotracheal intubation should not occur until at least 5 minutes after the start of the infusion.
    Maintenance period of anaesthesia: After endotracheal intubation the infusion rate can be titrated upward in 25% to 100% increments, or downward in 25% to 50% decrements, every 2 to 5 minutes according to patient need. Supplemental bolus doses, administered over not less than 30 seconds, may also be given every 2 to 5 minutes as required. High risk cardiac patients, such as those with poor ventricular function or undergoing valve surgery, should be administered a maximum bolus dose of 0.5 micrograms/kg. These dosing recommendations also apply during hypothermic cardiopulmonary bypass.
    Concomitant medication: At the doses recommended above, remifentanil significantly reduces the amount of hypnotic agent required to maintain anaesthesia. Therefore, isoflurane and propofol should be administered as recommended above to avoid excessive depth of anaesthesia. No data are available for dosage recommendations for simultaneous use of other hypnotics, other than those listed in prescribing information, with remifentanil.
    Guidelines for post-operative patient management: Use in Intensive Care: This product can be used for the provision of analgesia in mechanically ventilated intensive care patients. Sedative agents should be added as appropriate. It has been studied in mechanically ventilated intensive care patients in well controlled clinical trials for up to three days. As patients were not studied beyond three days, no evidence of safety and efficacy for longer treatment has been established. Therefore, the use of this product is not recommended for a duration of treatment greater than 3 days. In adults, it is recommended that this product is initiated at an infusion rate of 0.1 micrograms/kg/min (6 micrograms/kg/h) to 0.15 micrograms/kg/min (9 micrograms/kg/h). The infusion rate should be titrated in increments of 0.025 micrograms/kg/min (1.5 micrograms/kg/h) to achieve the desired level of sedation and analgesia. A period of at least 5 minutes should be allowed between dose adjustments. The level of sedation and analgesia should be carefully monitored, regularly reassessed and the infusion rate adjusted accordingly. If an infusion rate of 0.2 micrograms/kg/min (12 micrograms/kg/h) is reached and the desired level of sedation is not achieved, it is recommended that dosing with an appropriate sedative agent is initiated. The dose of sedative agent should be titrated to obtain the desired level of sedation. Further increases to the infusion rate in increments of 0.025 micrograms/kg/min (1.5 micrograms/kg/h) may be made if additional analgesia is required.
    See prescribing information for full details.


    Indications

    For I.V. administration as an analgesic agent for use during induction and/or maintenance of general anaesthesia under close supervision. For provision of analgesia and sedation in mechanically ventilated intensive care patients 18 years of age and over.


    Contra-Indications

    As glycine is present in the formulation, this product is contra-indicated for epidural and intrathecal use. Patients with known hypersensitivity to any component of the preparation and other fentanyl analogues. Use as the sole agent for induction of anaesthesia. Children under 2 years of age.


    Special Precautions

    This product should be administered only in a setting fully equipped for the monitoring and support of respiratory and cardiovascular function, and by persons specifically trained in the use of anaesthetic drugs and the recognition and management of the expected adverse effects of potent opioids, including respiratory and cardiac resuscitation. Such training must include the establishment and maintenance of a patent airway and assisted ventilation. The use of this product in mechanically ventilated intensive care patients is not recommended for duration of treatment greater than 3 days.
    Rapid offset of action /Transition to alternative analgesia: Due to the very rapid offset of action of this product, no residual opioid activity will be present within 5 to 10 minutes after the discontinuation of this product. For those patients undergoing surgical procedures where post-operative pain is anticipated, analgesics should be administered prior to discontinuation of this product. The possibility of tolerance, hyperalgesia and associated haemodynamic changes should be considered when used in Intensive Care Unit. Prior to discontinuation of this product, patients must be given alternative analgesic and sedative agents. Sufficient time must be allowed to reach the therapeutic effect of the longer acting analgesic. The choice of agent(s), the dose and the time of administration should be planned in advance and individually tailored to be appropriate for the patient’s surgical procedure and the level of post-operative care anticipated. When other opioid agents are administered as part of the regimen for transition to alternative analgesia, the benefit of providing adequate post-operative analgesia must always be balanced against the potential risk of respiratory depression with these agents. Discontinuation of Treatment. Inadvertent administration. Muscle rigidity – prevention and management. Respiratory depression – prevention and management. Cardiovascular effects. Drug abuse. See prescribing information for full details for following precautions.


    Side Effects

    The most common undesirable effects associated with remifentanil are direct extensions of μ -opioid agonist pharmacology. These adverse events resolve within minutes of discontinuing or decreasing the rate of remifentanil administration. Skeletal muscle rigidity, Hypotension, Nausea, vomiting.
    See prescribing information for full details.


    Manufacturer
    Teva Hungary
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