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Amikacin

Sammanfattning

Persistens. Amikacin är mycket persistent (vP).

Bioackumulering. Amikacin har låg potential att bioackumuleras.

Toxicitet. Amikacin har mycket hög kronisk toxicitet (OECD 201).

Risk. "Toxicity is reported as much lower as assessed in appropriately conducted studies as per OECD 210 and 211. PEC/PNEC comparisons do not indicate amikacin as posing a threat to the environment. However, due to the concern raised on the conduct of the OECD 201 study which was shown to be the most sensitive to the effects of amikacin, available data do not allow to conclude definitively on the potential risk of amikacin to the environment."

 

Denna sammanfattande information kommer från utredningsrapport för Arikayce liposomal (amikacin). Miljöinformation saknas på fass.se för amikacin (2023-10-24). Det är frivilligt för tillverkare att lämna uppgifter om miljöpåverkan på fass.se.

Detaljerad information

Utredningsrapport

Utredningsrapport för Arikayce liposomal (amikacin), 23 July 2020, EMA/473660/2020.

Fara

Persistens: "DT50, whole system (12 ºC)= 2629 days, % shifting to sediment = 22.6 (OECD 308). Conclusion: Amikacin can be considered very persistent. % partitioning to sediment >10%, hence Phase IIb sediment toxicity study triggered % orgC 3.4 and 0.64 for Taunton and Weweantic river systems respectively."

Bioackumulation: Log Kow < -2,00. "Conclusion: Below 4.5 threshold, no PBT screening warranted."

Toxicitet: Det finns data för 3 trofinivåer, känsligaste alg ("class Cyanophyceae") NOEC 1,7 mikrog/L (OECD 201).

Risk

"Toxicity is reported as much lower as assessed in appropriately conducted studies as per OECD 210 and 211. PEC/PNEC comparisons do not indicate amikacin as posing a threat to the environment. However, due to the concern raised on the conduct of the OECD 201 study which was shown to be the most sensitive to the effects of amikacin, available data do not allow to conclude definitively on the potential risk of amikacin to the environment."

"The applicant has completed an ERA in line with the EMAs ‘Guideline on the environmental risk
assessment of medicinal products for human use’. In general, the ERA was conducted appropriately but the applicant was requested to repeat the completed OECD 201 study as it did not meet its predefined validity criteria and has committed to do so in post-authorisation." Ingen sådan information har återfunnits på EMA:s webbplats (2023-10-24).

Författad vid avdelningen Kunskapsutveckling, Region Stockholm