Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Ibigen Srl, via Fossignano 2, 04011, Aprilia (LT), Italy
Rocuronium bromide 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 induction and to provide skeletal muscle relaxation during surgery.
In adults, Rocuronium bromide is also indicated to facilitate tracheal intubation during rapid sequence induction and as an adjunct in the intensive care unit (ICU) (e.g. to facilitate intubation) for short term use.
See also section 4.2 and 5.1.
Rocuronium bromide should only be administered by, or under supervision of, experienced clinicians who are familiar with the action and use of these medicinal products.
The dosage of Rocuronium bromide should be individualized 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 medicinal products 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 Rocuronium bromide.
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 Rocuronium bromide should be made by administering smaller maintenance doses at less frequent intervals or by using lower infusion rates of Rocuronium bromide during long lasting procedures (longer than 1 hour) under inhalational anaesthesia (see section 4.5).
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.
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 reference is made to section 4.6.
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 (see section 5.1).
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 control twitch height (train-of-four stimulation) are present.
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 control twitch height (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.
In patients undergoing Caesarean section, it is recommended to only use a dose of 0.6 mg rocuronium bromide per kg body weight, since a 1.0 mg/kg dose has not been investigated in this patient group.
Reversal of neuromuscular block induced by neuromuscular blocking agents may be inhibited or unsatisfactory in patients receiving magnesium salts for toxaemia of pregnancy because magnesium salts enhance neuromuscular blockade. Therefore, in these patients the dosage of rocuronium should be reduced and be titrated to twitch response.
For infants (28 days–23 months), children (2-11 years) and adolescents (12–18 years) the recommended intubation dose during routine anaesthesia and maintenance dose are similar to those in adults.
For continuous infusion in paediatrics, the infusion rates, with the exception of children, are the same as for adults. For children higher infusion rates might be necessary. For children the same initial infusion rates as for adults are recommended and this should be adjusted to maintain twitch response at 10% of control twitch height or to maintain 1 or 2 responses to control twitch height (train-of-four stimulation) during the procedure.
There are insufficient data to support dose recommendations for the use of rocuronium bromide in new-born infants (0-1 month).
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.
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 however adequate conditions for intubation may not be established for 90 seconds after administration of rocuronium bromide. 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 also Continuous infusion).
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.
For tracheal intubation, the same doses should be used as described above under surgical procedures.
Rocuronium bromide is not recommended for the facilitation of mechanical ventilation in the intensive care due to a lack of data on safety and efficacy.
This medicinal product is for single use only. Any unused solution should be discarded.
Rocuronium bromide is administered intravenously either as a bolus injection or as a continuous infusion (see section 6.6).
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 rocuronium bromide, 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.
Shelf life: 36 months.
Shelf-life after first opening: The solution should be used immediately after opening the ampoule/vial. Discard any unused contents.
In-use shelf-life diluted medicinal product: After dilution with infusion fluids (see section 6.6), chemical and physical in-use stability has been demonstrated for 24 hours at 25°C. From a microbiological point of view, the diluted product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user/administrator and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Store in a refrigerator (2°C-8°C).
Do not freeze.
Keep the ampoule/vial in the outer carton in order to protect from light.
Rocuronium bromide may also be stored outside the refrigerator at a temperature of up to 25°C for a maximum of 12 weeks, after which it should be discarded. The product should not be placed back into the refrigerator, once it has been kept outside.
For storage conditions after first opening and of the diluted medicinal product, see section 6.3.
For vials: Clear, colourless glass (type I), closed with bromobutyl rubber stopper and polypropylene flip-off cap.
For ampoules: Clear, colourless glass (type I).
Ampoules/Vials of 5 and 10 ml.
Pack sizes:
10x 5 ml
12x 5 ml
(6x 10) x 5 ml
10x 10 ml
(2x 10) x 10 ml
Not all pack sizes may be marketed.
Compatibility studies with the following infusion fluids have been performed: in nominal concentration of 5 mg/ml Rocuronium bromide has been shown to be compatible with: sodium chloride 9 mg/ml (0.9%) solution, glucose 50 mg/ml (5%) solution, glucose 33 mg/ml (3.3%) in sodium chloride 3 mg/ml (0.3%) solution, water for injections and Lactated Ringers. Administration should begin immediately after mixing, and should be completed within 24 hours.
Single use only. Any unused product or waste material should be disposed of in accordance with local requirements.
Do not use Rocuronium bromide if you notice that the solution is not clear and not free from particles.
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