Esmeron^®

Injektionsvätska, lösning  10 mg/ml

Muskelrelaxans

Aktiv substans

ATC-kod

(visar liknande läkemedel)

Läkemedlet omfattas av Läkemedelsförsäkringen

Detaljerad miljöinformation

Risk Assessment

A Predicted Environmental Concentration (PEC) was developed for rocuronium bromide using the methodology provided in “Environmental classification of pharmaceuticals in www.fass.se – guidance for pharmaceutical companies, January 2007”. The predicted environmental concentration was calculated using Equation 2 and presented in Table 1:

PEC (μg/L) = 1.5x10^-6 x A x (100-r)

where,

A = Total actual sales in Sweden for the most recent year, 2009 (kg/yr)

r = Removal rate in the sewage treatment plant (%)

Table 1. Calculation of the PEC

Predicted No-Effect Concentrations could not be derived for this compound as no ecotoxicity data are available.

Persistence

No degradation data are available for rocuronium bromide.

Bioaccumulation

Rocuronium bromide has no significant bioaccumulation potential, as indicated by the measured log Kow value of 0,1 at 25°C (measured by titrametric method).

Conclusion

Based on this assessment, the environmental risk of the active pharmaceutical ingredient of ESMERON (rocuronium bromide) cannot be excluded as little data are available for this compound.

References

Organon, 2004. General Properties, Rocuronium bromide. Organon R&D Report NL0048689.