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10 X 5 ml
Like other neuromuscular blocking agents, Rocurim should only be administered by, or under supervision of, experienced clinicians who are familiar with the action and use of these drugs.
As with other neuromuscular blocking agents, the dosage of Rocurim should be individualised in each patient. The method of anaesthesia and the expected duration of surgery, the method of sedation and the expected duration of mechanical ventilation, the possible interaction with other drugs that are administered concomitantly, and the condition of the patient should be taken into account when determining the dose.
The use of an appropriate neuromuscular monitoring technique is recommended for the evaluation of neuromuscular block and recovery.
Inhalational anaesthetics do potentiate the neuromuscular blocking effects of Rocurim. This potentiation however, becomes clinically relevant in the course of anaesthesia, when the volatile agents have reached the tissue concentrations required for this interaction. Consequently, adjustments with Rocurim should be
made by administering smaller maintenance doses at less frequent intervals or by using lower infusion rates of Rocurim during long lasting procedures (longer than 1 hour) under inhalational anaesthesia.
In adult patients the following dosage recommendations may serve as a general guideline for tracheal intubation and muscle relaxation for short to long lasting surgical procedures and for use in the intensive care unit.
Tracheal intubation: The standard intubating dose during routine anaesthesia is 0.6 mg/kg rocuronium bromide, after which adequate intubation conditions are established within 60 seconds in nearly all patients. A dose of 1.0 mg/kg rocuronium bromide is recommended for facilitating tracheal intubation conditions during rapid sequence induction of anaesthesia, after which adequate intubation conditions are established within 60 seconds in nearly all patients. If a dose of 0.6 mg/kg rocuronium bromide is used for rapid sequence induction of anaesthesia, it is recommended to intubate the patient 90 seconds after administration of rocuronium bromide. For use of rocuronium bromide during rapid sequence induction of anaesthesia in patients undergoing Caesarean section.
Higher doses: Should there be reason for selection of larger doses in individual patients, there is no indication from clinical studies that the use of initial doses up to 2 mg/kg rocuronium bromide is associated with an increased frequency or severity of cardiovascular effects. The use of these high dosages of rocuronium bromide decreases the onset time and increases the duration of action.
Maintenance dosing: The recommended maintenance dose is 0.15 mg/kg rocuronium bromide; in the case of long-term inhalational anaesthesia this should be reduced to 0.075-0.1 mg/kg rocuronium bromide. The maintenance doses should best be given when twitch height has recovered to 25% of control twitch height, or when 2 to 3 responses to train of four stimulation are present.
Continuous infusion: If rocuronium bromide is administered by continuous infusion, it is recommended to give a loading dose of 0.6 mg/kg rocuronium bromide and, when neuromuscular block starts to recover, to start administration by infusion. The infusion rate should be adjusted to maintain twitch response at 10% of control twitch height or to maintain 1 to 2 responses to train of four stimulation. In adults under intravenous anaesthesia, the infusion rate required to maintain neuromuscular block at this level ranges from 0.3-0.6 mg/kg/h (300-600 micrograms/kg/h) and under inhalational anaesthesia the infusion rate ranges from 0.3-0.4 mg/kg/h. Continuous monitoring of neuromuscular block is essential since infusion rate requirements vary from patient to patient and with the anaesthetic method used.
Paediatric population: For neonates (0-27 days), infants (28 days-2 months), toddlers (323 months), children (2-11 years) and adolescents (12-17 years) the recommended intubation dose during routine anaesthesia and maintenance dose are similar to those in adults. However, the duration of action of the single intubating dose will be longer in neonates and infants than in children. For continuous infusion in paediatrics, the infusion rates, with the exception of children (2-11 years), are the same as for adults. For children aged 2-11 years higher infusion rates might be necessary. Thus, for children (2-11 years) the same initial infusion rates as for adults are recommended and then this should be adjusted to maintain twitch response at 10% of control twitch height or to maintain 1 or 2 responses to train of four stimulation during the procedure. The experience with rocuronium bromide in rapid sequence induction in paediatric patients is limited. Rocuronium bromide is therefore not recommended for facilitating tracheal intubation conditions during rapid sequence induction in paediatric patients.
Geriatric patients and patients with hepatic and/or biliary tract disease and/or renal failure: The standard intubation dose for geriatric patients and patients with hepatic and/or biliary tract disease and/or renal failure during routine anaesthesia is 0.6 mg/kg rocuronium bromide. A dose of 0.6 mg/kg should be considered for rapid sequence induction of anaesthesia in patients in which a prolonged duration of action is expected. Regardless of the anaesthetic technique used, the recommended maintenance dose for these patients is 0.075-0.1 mg/kg rocuronium bromide, and the recommended infusion rate is 0.3-0.4 mg/kg/h (see Continuous infusion).
Overweight and obese patients: When used in overweight or obese patients (defined as patients with a body weight of 30% or more above ideal body weight) doses should be reduced taking into account ideal body weight.
Intensive Care Procedures
Tracheal intubation: For tracheal intubation, the same doses should be used as described above under surgical procedures.
Maintenance dosing: The use of an initial loading dose of 0.6 mg/kg rocuronium bromide is recommended, followed by a continuous infusion as soon as twitch height recovers to 10% or upon reappearance of 1 to 2 twitches to train of four stimulation. Dosage should always be titrated to effect in the individual patient. The recommended initial infusion rate for the maintenance of a neuromuscular block of 8090% (1 to 2 twitches to TOF stimulation) in adult patients is 0.30.6 mg/kg/h during the first hour of administration, which will need to be decreased during the following 6-12 hours, according to the individual response. Thereafter, individual dose requirements remain relatively constant. A large between patient variability in hourly infusion rates has been found in controlled clinical studies, with mean hourly infusion rates ranging from 0.2-0.5 mg/kg/h depending on nature and extent of organ failure(s), optimal individual patient control, monitoring of neuromuscular transmission iconcomitant medication and individual patient characteristics. To provide s strongly recommended. Administration up to 7 days has been investigated.
Special populations: Rocurim is not recommended for the facilitation of mechanical ventilation in the intensive care in paediatric and geriatric patients due to a lack of data on safety and efficacy.
Method of administration: Rocurim is administered intravenously either as a bolus injection or as a continuous infusionץ
Rocurim is indicated in adult and paediatric patients (from term neonates to adolescents [0 to <18 years]) as an adjunct to general anaesthesia to facilitate tracheal intubation during routine sequence induction and to provide skeletal muscle relaxation during surgery. In adults Rocurim is also indicated to facilitate
tracheal intubation during rapid sequence induction and as an adjunct in the intensive care unit (ICU) to facilitate intubation and mechanical ventilation.
Hypersensitivity to rocuronium or to the bromide ion or to any of the excipients.
Since Rocuronium causes paralysis of the respiratory muscles, ventilatory support is mandatory for patients treated with this drug until adequate spontaneous respiration is restored. As with all neuromuscular blocking agents, it is important to anticipate intubation difficulties, particularly when used as part of a rapid sequence induction technique.
As with other neuromuscular blocking agents, residual neuromuscular blockade has been reported for Rocuronium. In order to prevent complications resulting from residual neuromuscular blockade, it is recommended to extubate only after the patient has recovered sufficiently from neuromuscular block. Geriatric patients (65 years or older) may be at increased risk for residual neuromuscular block. Other factors which could cause residual neuromuscular blockade after extubation in the post-operative phase (such as drug interactions or patient condition) should also be considered. If not used as part of standard clinical practice, the use of a reversal agent (such as sugammadex or acetylcholinesterase inhibitors) should be considered, especially in those cases where residual neuromuscular blockade is more likely to occur.
High rates of cross-sensitivity between neuromuscular blocking agents have been reported. Therefore, where possible, before administering Rocuronium, hypersensitivity to other neuromuscular blocking agents should be excluded. Rocuronium should only be used when absolutely essential in susceptible patients. Patients who experience a hypersensitivity reaction under general anaesthesia should be tested subsequently for hypersensitivity to other neuromuscular blockers.
Rocuronium may increase the heart rate.
In general, following long term use of neuromuscular blocking agents in the ICU, prolonged paralysis and/or skeletal muscle weakness has been noted. In order to help preclude possible prolongation of neuromuscular block and/or overdosage it is strongly recommended that neuromuscular transmission is monitored throughout the use of neuromuscular blocking agents.
In addition, patients should receive adequate analgesia and sedation. Furthermore, neuromuscular blocking agents should be titrated to effect in the individual patients by or under supervision of experienced clinicians who are familiar with their actions and with appropriate neuromuscular monitoring techniques.
Myopathy after long term administration of other non-depolarising neuromuscular blocking agents in the ICU in combination with corticosteroid therapy has been reported regularly. Therefore, for patients receiving both neuromuscular blocking agents and corticosteroids, the period of use of the neuromuscular blocking agent should be limited as much as possible.
If suxamethonium is used for intubation, the administration of Rocuronium should be delayed until the patient has clinically recovered from the neuromuscular block induced by suxamethonium.
See prescribing information for full details.
The most commonly occurring adverse drug reactions include injection site pain/reaction, changes in vital signs and prolonged neuromuscular block. The most frequently reported serious adverse drug reactions during post-marketing surveillance is ‘anaphylactic and anaphylactoid reactions’ and associated symptoms.
See prescribing information for full details.
The following drugs have been shown to influence the magnitude and/or duration of action of non-depolarising neuromuscular blocking agents.
Effect of other drugs on Rocurim
• Halogenated volatile anaesthetics potentiate the neuromuscular block of Rocurim. The effect only becomes apparent with maintenance dosing. Reversal of the block with acetylcholinesterase inhibitors could also be inhibited.
• After intubation with suxamethonium.
• Long-term concomitant use of corticosteroids and Rocurim in the ICU may result in prolonged duration of neuromuscular block or myopathy.
• antibiotics: aminoglycoside, lincosamide and polypeptide antibiotics, acylamino-penicillin antibiotics.
• diuretics, quinidine and its isomer quinine, magnesium salts, calcium channel blocking agents, lithium salts, local anaesthetics (lidocaine i.v, bupivacaine epidural) and acute administration of phenytoin or ß-blocking agents.
Recurarisation has been reported after post-operative administration of: aminoglycoside, lincosamide, polypeptide and acylamino-penicillin antibiotics, quinidine, quinine and magnesium salts.
• Prior chronic administration of phenytoin or carbamazepine.
• Calcium chloride, potassium chloride.
• Protease inhibitors (gabexate, ulinastatin).
• Administration of other non-depolarising neuromuscular blocking agents in combination with Rocurim may produce attenuation or potentiation of the neuromuscular block, depending on the order of administration and the neuromuscular blocking agent used.
• Suxamethonium given after the administration of Rocurim may produce potentiation or attenuation of the neuromuscular blocking effect of Rocurim.
Effect of Rocurim on other drugs
Rocurim combined with lidocaine may result in a quicker onset of action of lidocaine.
Paediatric population: No formal interaction studies have been performed. The above mentioned interactions for adults and their special warnings and
precautions for use should be taken into account for paediatric patients.
Pregnancy and Lactation
Pregnancy: For rocuronium bromide, no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Caution should be exercised when prescribing Rocurim to pregnant women.
Caesarean section: In patients undergoing Caesarean section, Rocurim can be used as part of a rapid sequence induction technique, provided no intubation difficulties are anticipated and a sufficient dose of anaesthetic agent is administered or following suxamethonium facilitated intubation. However, Rocurim, administered in doses of 0.6 mg/kg may not produce adequate conditions for intubation until 90 seconds after administration. This dose has been shown to be safe in parturients undergoing Caesarean section.
Rocuronium does not affect Apgar score, foetal muscle tone or cardiorespiratory adaptation. From umbilical cord blood sampling it is apparent that only limited placental transfer of rocuronium bromide occurs which does not lead to the observation of clinical adverse effects in the newborn.
Note 1: doses of 1.0 mg/kg have been investigated during rapid sequence induction of anaesthesia, but not in Caesarean section patients. Therefore, only a dose of 0.6 mg/kg is recommended in this patient group.
Note 2: Reversal of neuromuscular block induced by neuromuscular blocking agents may be inhibited or unsatisfactory in patients receiving magnesium salts for toxemia of pregnancy because magnesium salts enhance neuromuscular blockade.
Therefore, in these patients the dosage of Rocurim should be reduced and be titrated to twitch response.
Lactation: It is unknown whether rocuronium bromide is excreted in human breast milk. Animal studies have shown insignificant levels of rocuronium bromide in breast milk.
Insignificant levels of rocuronium bromide were found in the milk of lactating rats. There are no human data on the use of Rocurim during lactation. Rocurim should be given to lactating women only when the attending physician decides that the benefits outweigh the risks.
In the event of overdosage and prolonged neuromuscular block, the patient should continue to receive ventilatory support and sedation. There are two options for the reversal of neuromuscular block: (1) In adults, sugammadex can be used for reversal of intense (profound) and deep block. The dose of sugammadex to be administered depends on the level of neuromuscular block. (2) An acetylcholinesterase inhibitor (e.g. neostigmine, edrophonium, pyridostigmine) or sugammadex can be used once spontaneous recovery starts and should be administered in adequate doses.
When administration of an acetylcholinesterase inhibiting agent fails to reverse the neuromuscular effects of Rocurim, ventilation must be continued until spontaneous breathing is restored.
Repeated dosage of an acetylcholinesterase inhibitor can be dangerous.
In animal studies, severe depression of cardiovascular function, ultimately leading to cardiac collapse did not occur until a cumulative dose of 750 x ED90 (135 mg/kg rocuronium bromide) was administered.
Incompatibilities: Physical incompatibility has been documented for rocuronium when added to solutions containing the following drugs: amphotericin, amoxicillin, azathioprine, cefazolin, cloxacillin, dexamethasone, diazepam, enoximone, erythromycin, famotidine, furosemide, hydrocortisone sodium succinate, insulin, intralipid, methohexital, methylprednisolone, prednisolone sodium succinate, thiopental, trimethoprim and vancomycin.
Rocurim must not be mixed with other medicinal products except those mentioned in section 6.6 at the attached doctor’s leaflet.
If Rocurim is administered via the same infusion line that is also used for other drugs, it is important that this infusion line is adequately flushed (e.g. with 0.9% NaCl) between administration of Rocurim and drugs for which incompatibility with Rocurim has been demonstrated or for which compatibility with Rocurim has not been established.
Shelf life: The expiry date is stated on the carton and on the label of the vial.
From microbuological point of view, since Rocurim does not contain a preservative, the solution should be used immediately after opening the vial.
After dilution, chemical and physical in-use stability has been demonstated for 24 hours.
Storage: Storage in the Refrigerator: Rocurim should be stored at 2°-8°C protected from light and used within the expiry date given on the pack.
Storage out of the refrigerator: Rocurim may also be stored outside of the refrigerator at a temperature of up to 25°C for a maximum 12 weeks, after which it should be discarded. The product should not be placed back into
the refrigerator, once it has been kept outside. The storage period must not exceed the shelf-life.