CISATRACURIUM BESILATE

Cisatracurium besilate should only be administered by or under the supervision of anaesthetists or other clinicians who are familiar with the use and action of neuromuscular blocking agents. Facilities for tracheal intubation, and maintenance of pulmonary ventilation and adequate arterial oxygenation have to be available.

2). Cisatracurium besilate contains no antimicrobial preservative and is intended for single patient use. Monitoring advice As with other neuromuscular blocking agents, monitoring of neuromuscular function is recommended during the use of Cisatracurium besilate in order to individualise dosage requirements.

15mg/kg (body weight). This dose produced good to excellent conditions for tracheal intubation 120 seconds after administration of cisatracurium, following induction of anaesthesia with propofol. Higher doses will shorten the time to onset of neuromuscular block.

4 mg/kg (body weight) to healthy adult patients during opioid (thiopentone/fentanyl/midazolam) or propofol anaesthesia. 9 91 * T1 Single twitch response as well as the first component of the Train-of-four response of the adductor pollicis muscle following supramaximal electrical stimulation of the ulnar nerve.

Enflurane or isoflurane anaesthesia may extend the clinically effective duration of an initial dose of Cisatracurium besilate by as much as 15%. Maintenance Neuromuscular block can be extended with maintenance doses of Cisatracurium besilate .

03 mg/kg (body weight) provides approximately 20 minutes of additional clinically effective neuromuscular block during opioid or propofol anaesthesia. Consecutive maintenance doses do not result in progressive prolongation of effect.

Spontaneous Recovery Once spontaneous recovery from neuromuscular block is underway, the rate is independent of the Cisatracurium besilate dose administered. During opioid or propofol anaesthesia, the median times from 25 to 75% and from 5 to 95% recovery are approximately 13 and 30 minutes, respectively.

Reversal Neuromuscular block following cisatracurium administration is readily reversible with standard doses of anticholinesterase agents. 7) are approximately 4 and 9 minutes respectively, following administration of the reversal agent at an average of 10% T1 recovery.

Data from pooled internal clinical trials were used to determine the frequency of very common to uncommon adverse reactions. The following convention has been used for the classification of frequency: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1,000 to <1/100), rare (≥ 1/10,000 to <1/1,000), very rare (< 1/10,000) and unknown (cannot be estimated from the available data).

Clinical Trial Data Cardiac disorders Common Bradycardia Vascular disorders Common Hypotension Uncommon Cutaneous flushing Respiratory, thoracic and mediastinal disorders Uncommon Bronchospasm Skin and subcutaneous tissue disorders Uncommon Rash Post-marketing data Immune system disorders Very rare Anaphylactic reaction, Anaphylactic shock Anaphylactic reactions of varying degrees of severity have been observed after the administration of neuromuscular blocking agents, including anaphylactic shock.

Very rarely, severe anaphylactic reactions have been reported in patients receiving cisatracurium in conjunction with one or more anaesthetic agents. Musculoskeletal and connective tissue disorders Very rare Myopathy, muscle weakness There have been some reports of muscle/weakness and/or myopathy following prolonged use of muscle relaxants in severely ill patients in the ICU.

Most patients were receiving concomitant corticosteroids. These events have been reported infrequently in association with cisatracurium and a causal relationship has not been established. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Product specific topics Cisatracurium paralyses the respiratory muscles as well as other skeletal muscles but has no known effect on consciousness or pain threshold. Cisatracurium besilate should be only administered by or under the supervision of anaesthetists or other clinicians who are familiar with the use and action of neuromuscular blocking agents.

Facilities for tracheal intubation, and maintenance of pulmonary ventilation and adequate arterial oxygenation have to be available. 3). Cisatracurium does not have significant vagolytic or ganglion-blocking properties. Consequently, cisatracurium has no clinically significant effect on heart rate and will not counteract the bradycardia produced by many anaesthetic agents or by vagal stimulation during surgery.

Patients with myasthenia gravis and other forms of neuromuscular disease have shown greatly increased sensitivity to non-depolarising blocking agents. 02 mg/kg Cisatracurium besilate is recommended in these patients. Severe acid-base and/or serum electrolyte abnormalities may increase or decrease the sensitivity of patients to neuromuscular blocking agents.

There is no information on the use of cisatracurium in neonates aged less than one month since it has not been studied in this patient population. Cisatracurium has not been studied in patients with a history of malignant hyperthermia.

Studies in malignant hyperthermia- susceptible pigs indicated that cisatracurium does not trigger this syndrome. There have been no studies of cisatracurium in patients undergoing surgery with induced hypothermia (25 to 28°C). As with other neuromuscular blocking agents the rate of infusion required to maintain adequate surgical relaxation under these conditions may be expected to be significantly reduced.

Cisatracurium has not been studied in patients with burns; however, as with other non-depolarising neuromuscular blocking agents, the possibility of increased dosing requirements and shortened duration of action must be considered if Cisatracurium besilate injection is administered to these patients.

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