Miljöpåverkan
Fidaxomicin
Miljörisk:
Risk för miljöpåverkan av fidaxomicin kan inte uteslutas då det inte finns tillräckliga ekotoxikologiska data.
Nedbrytning:
Det kan inte uteslutas att fidaxomicin är persistent, då data saknas.
Bioackumulering:
Det kan inte uteslutas att fidaxomicin kan bioackumuleras, då data saknas.
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Detaljerad miljöinformation
Environmental Risk Classification
Predicted Environmental Concentration (PEC)
PEC is calculated according to the following formula:
PEC (µg/L) = (A*109 *(100-R))/(365*P*V*D*100) = 1.37*10-6*A(100-R)
A: 1.204 kg total sold amount API of fidaxomicin in Sweden year 2021, data from IQVIA (Ref. I)
R: 0 % (removal rate)
P: 10*106 (nr of inhabitants in Sweden)
V: 200 L/day (volume of wastewater per capita and day) (ECHA default) (Ref. II)
D: 10 (factor of dilution of wastewater by surface water flow) (ECHA default) (Ref. II))
PEC 1.37*10-6*1.204(100-0) =
PEC 0.000165 µg/L
Environmental risk classification (PEC/PNEC ratio)
Risk of environmental impact of fidaxomicin cannot be excluded, since no ecotoxicity data are available.
REFERENCES
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Data from IQVIA ”Consumption assessment in kg for input to environmental classification v1 - updated 2022 (data 2021)”.
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ECHA, European Chemicals Agency. Guidance on information requirements and chemical safety assessment. May 2008.
http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm