Pavulon^®

Injektionsvätska, lösning  2 mg/ml

Muskelrelaxans

Aktiv substans

ATC-kod

(visar liknande läkemedel)

Läkemedlet omfattas av Läkemedelsförsäkringen

Detaljerad miljöinformation

Risk Assessment

A Predicted Environmental Concentration (PEC) was estimated for pancuronium (di) 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 was available.

Persistence

No studies on the degradation of Pancuronium (di) bromide have been conducted.

Bioaccumulation

Pancuronium (di) bromide has no significant bioaccumulation potential, as indicated by the measured logKow value of -1,17 (1).

Conclusion

Based on this assessment, the environmental risk of the active pharmaceutical ingredient of PAVULON (pancuronium (di) bromide hydrochloride) cannot be excluded as little data are available for this compound, however the low PEC indicates the risk will be insignificant.

References

(1) Lipid solubility of pancuronium and vecuronium determined by n-octanol/water partitioning. Weindlmayr-Goetell M et al. Br. J. Anaesth. 1993, 70, pp. 579-80.