Published: 31 July 2020
Revised: 16 March 2021
Safety Information
Monitoring
Update to original communication
16 March 2021
Monitoring finishes on 31 May 2021.
Since October 2020 no further reports of lack of efficacy have been reported for Rocuronium bromide solution for injection 10mg/mL, Hameln. A full quality review of multiple batches was undertaken by the New Zealand sponsor and no quality issues were identified. Independent testing was also conducted by Medsafe which was consistent with the sponsor’s findings.
Medsafe will continue to monitor this issue through routine pharmacovigilance.
Original Communication - Rocuronium bromide solution for injection 10mg/mL, Hameln, and reports of lack of efficacy
31 July 2020
Medsafe has received reports of lack of efficacy of Rocuronium bromide solution for injection 10mg/mL, Hameln, batch 11331219A. At this stage the product is not under recall, we are monitoring this situation.
The supplier of this product, Max Health, has performed an initial investigation on the manufacture and distribution of the named batch and there is no evidence as yet to suggest an issue which would impact on the safety, quality or efficacy of this batch. However, Medsafe is requesting details of any further cases of efficacy concerns with this product.
The sponsor has available a reporting form (PDF, 323KB, 3 pages) to capture relevant clinical information for issues with this medicine. Please report any cases to Medsafe and the company using the Efficacy of Neuromuscular Blocking Drugs Information Collection Form.
Products affected
Additional information
Regulator actions
Reporting
Products affected
Rocuronium bromide solution for injection 10mg/mL, Hameln
Rocuronium bromide solution for injection 10mg/mL, Hameln is approved:
- As an adjunct to general anaesthesia to facilitate tracheal intubation during routine induction, and during rapid sequence induction when suxamethonium is contraindicated.
- As an adjunct in the Intensive Care Unit (ICU) to facilitate intubation and mechanical ventilation.
Additional information
Rocuronium bromide solution for injection 10mg/mL, Hameln is a prescription medicine and is funded by PHARMAC (sole subsidy as of 1 August 2020). PHARMAC is aware of the issue and will continue to work with the supplier to maintain supply.
It is important to note that the dosage and subsequent response to this medicine is patient specific. The product datasheet contains the following advice in relation to administration:
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 medicines 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.
Regulator actions
Medsafe is continuing to monitor reports of lack of efficacy Rocuronium bromide solution for injection 10mg/mL, Hameln.
Medsafe is investigating the reported issues and is in contact with the New Zealand sponsor.
Reporting
Healthcare professionals are encouraged to report quality issues related to this medicine to Medsafe at recalls@health.govt.nz. Please use the form in the link above.
Healthcare professionals are encouraged to report suspected adverse reactions to medicines to the Centre for Adverse Reactions Monitoring (CARM).
