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  • Ultiva 1 mg, 2 mg, 5 mg
    / Perrigo


    Active Ingredient
    Remifentanil HCl 1, 2, 5 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    1×1 mg

    not in the basket chart 43552 21065

    Vial

    1×2 mg

    not in the basket chart 43557 21066

    Vial

    1×5 mg

    not in the basket chart 43558 21061

    Related information


    Dosage

    Remifentanil 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. Continuous infusions of Remifentanil must be administered by a calibrated infusion device into a fast flowing IV line or via a dedicated IV line. This infusion line should be connected at, or close to, the venous cannula and primed, to minimise the potential dead space. Remifentanil may also be given by target controlled infusion (TCI) with an approved infusion device incorporating the Minto pharmacokinetic model with covariates for age and lean body mass (LBM). Remifentanil is for intravenous use only and must not be administered by epidural or intrathecal injection.
    Dilution: For manually-controlled infusion Remifentanil can be diluted to concentrations of 20 to 250 micrograms/ml (50 micrograms/ml is the recommended dilution for adults).
    See prescribing information for full details.
    The administration of Remifentanil must be individualised based on the patient’s response. For specific dosing guidelines for patients undergoing cardiac surgerySee prescribing information for full details. When given by bolus injection at induction Remifentanil should be administered over not less than 30 seconds. 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 an increase of haemodynamic effects such as hypotension and bradycardia.
    Induction of anaesthesia: Remifentanil should be administered with a standard dose of a hypnotic agent, such as propofol, thiopentone, or isoflurane, for the induction of anaesthesia. Administering Remifentanil after an hypnotic agent will reduce the incidence of muscle rigidity. Remifentanil 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 Remifentanil, then a bolus injection is not necessary.
    Maintenance of anaesthesia in ventilated patients: After endotracheal intubation, the infusion rate of Remifentanil should be decreased, according to anaesthetic technique, see prescribing information for full details. Due to the fast onset and short duration of action of Remifentanil, 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 mu-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.
    For guidelines for discontinuation/continuation into the immediate post-operative period: See prescribing information for full details.


    Indications

    Analgesic agent for use during induction and/or maintenance of general anaesthesia under close supervision. Remifentanil is indicated 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, Remifentanil is contraindicated for epidural and intrathecal use. Remifentanil is contraindicated in patients with known hypersensitivity to any component of the preparation and other fentanyl analogues. Remifentanil is contraindicated for use as the sole agent for induction of anaesthesia. Children under 2 years of age.


    Special Precautions

    Remifentanil 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 Remifentanil in mechanically ventilated intensive care patients is not recommended for a duration of treatment greater than 3 days. Patients with a known hypersensitivity to opioids of a different class may exhibit a hypersensitivity reaction following administration of Remifentanil. Caution should be exercised before using Remifentanil in these patients. Rapid offset of action /Transition to alternative analgesia. Due to the very rapid offset of action of Remifentanil, no residual opioid activity will be present within 5 to 10 minutes after the discontinuation of Remifentanil. For those patients undergoing surgical procedures where post-operative pain is anticipated, analgesics should be administered prior to discontinuation of Remifentanil. The possibility of tolerance, hyperalgesia and associated haemodynamic changes should be considered when used in Intensive Care Unit. Prior to discontinuation of Remifentanil, 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: Symptoms following withdrawal of Remifentanil including tachycardia, hypertension and agitation have been reported infrequently upon abrupt cessation, particularly after prolonged administration of more than 3 days. Where reported, re-introduction and tapering of the infusion has been beneficial. The use of Remifentanil in mechanically ventilated intensive care patients is not recommended for duration of treatment greater than 3 days.
    Inadvertent administration: A sufficient amount of Remifentanil may be present in the dead space of the IV line and/or cannula to cause respiratory depression, apnoea and/or muscle rigidity if the line is flushed with IV fluids or other drugs. This may be avoided by administering Remifentanil into a fast flowing IV line or via a dedicated IV line which is removed when Remifentanil is discontinued.
    Muscle rigidity – prevention and management: At the doses recommended muscle rigidity may occur. As with other opioids, the incidence of muscle rigidity is related to the dose and rate of administration. Therefore, bolus injections should be administered over not less than 30 seconds. Muscle rigidity induced by remifentanil must be treated in the context of the patient’s clinical condition with appropriate supporting measures including ventilatory support. Excessive muscle rigidity occurring during the induction of anaesthesia should be treated by the administration of a neuromuscular blocking agent and/or additional hypnotic agents. Muscle rigidity seen during the use of remifentanil as an analgesic may be treated by stopping or decreasing the rate of administration of remifentanil. Resolution of muscle rigidity after discontinuing the infusion of remifentanil occurs within minutes. Alternatively an opioid antagonist may be administered, however this may reverse or attenuate the analgesic effect of remifentanil.
    Respiratory depression – prevention and management: As with all potent opioids, profound analgesia is accompanied by marked respiratory depression. Therefore, remifentanil should only be used in areas where facilities for monitoring and dealing with respiratory depression are available. The appearance of respiratory depression should be managed appropriately, including decreasing the rate of infusion by 50%, or by a temporary discontinuation of the infusion. Unlike other fentanyl analogues, remifentanil has not been shown to cause recurrent respiratory depression even after prolonged administration. However, as many factors may affect post-operative recovery it is important to ensure that full consciousness and adequate spontaneous ventilation are achieved before the patient is discharged from the recovery area.
    Cardiovascular effects: The risk of cardiovascular effects such as hypotension and which may rarely lead to asystole/cardiac arrest may be reduced by lowering the rate of infusion of Remifentanil or the dose of concurrent anaesthetics or by using IV fluids, vasopressor or anticholinergic agents as appropriate. Debilitated, hypovolaemic, and elderly patients may be more sensitive to the cardiovascular effects of remifentanil.
    Drug abuse: As with other opioids remifentanil may produce dependency.


    Side Effects

    Skeletal muscle rigidity, Bradycardia, Hypotension, Post-operative hypertension, Nausea, vomiting.
    See prescribing information for full details.


    Drug interactions

    Remifentanil is not metabolised by plasmacholinesterase, therefore, interactions with drugs metabolised by this enzyme are not anticipated.
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: There are no adequate and well-controlled studies in pregnant women. Remifentanil should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. See prescribing information for full details.
    Lactation: It is not known whether remifentanil is excreted in human milk.
    See prescribing information for full details.


    Overdose

    As with all potent opioid analgesics, overdose would be manifested by an extension of the pharmacologically predictable actions of remifentanil. Due to the very short duration of action of Remifentanil, the potential for deleterious effects due to overdose is limited to the immediate time period following drug administration. Response to discontinuation of the drug is rapid, with return to baseline within ten minutes. In the event of overdose, or suspected overdose, take the following actions: discontinue administration of Remifentanil, maintain a patent airway, initiate assisted or controlled ventilation with oxygen, and maintain adequate cardiovascular function. If depressed respiration is associated with muscle rigidity, a neuromuscular blocking agent may be required to facilitate assisted or controlled respiration. Intravenous fluids and vasopressor agents for the treatment of hypotension and other supportive measures may be employed.
    Intravenous administration of an opioid antagonist such as naloxone may be given as a specific antidote in addition to ventilatory support to manage severe respiratory depression. The duration of respiratory depression following overdose with Remifentanil is unlikely to exceed the duration of action of the opioid antagonist.


    Important notes

    Storage: Store at or below 25°C. The reconstituted solution is chemically and physically stable for 24 hours at room temperature (25°C). However, the drug does not contain an antimicrobial preservative and thus care must be taken to assure the sterility of prepared solutions, reconstituted product should be used promptly, and any unused material discarded.
    Compatibility: It should not be reconstituted, diluted or mixed with Lactated Ringer’s Injection or Lactated Ringer’s and 5% Dextrose Injection. This drug should not be mixed with propofol in the same infusion bag prior to administration. Administration of the drug into the same intravenous line with blood/serum/plasma is not recommended. Non-specific esterases in blood products may lead to the hydrolysis of remifentanil to its inactive metabolite. The drug should not be mixed with other therapeutic agents prior to administration.
    See prescribing information for full details.


    Manufacturer
    GlaxoSmithKline Manufacturing S.p.A, Parma, Italy
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