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Cerubidin®

Miljöinformation
Receptstatus
Förmånsstatus
Sanofi AB

Pulver till infusionsvätska, lösning 20 mg
(Pulver)

Cytostatikum

Aktiv substans:
ATC-kod: L01DB02
Utbytbarhet: Utbytbara läkemedel
Läkemedel från Sanofi AB omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöinformation

Miljöpåverkan

Daunorubicin

Miljörisk: Risk för miljöpåverkan av daunorubicin kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning: Det kan inte uteslutas att daunorubicin är persistent, då data saknas.
Bioackumulering: Daunorubicin har låg potential att bioackumuleras.


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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)


PEC = 0.00003 µg/L


Where:

A = 0.18888 kg (total sold amount API in Sweden year 2021, data from IQVIA)

R = 0% removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation)

P = number of inhabitants in Sweden = 10*106

V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (Ref I).

D = factor of dilution of waste water by surface water flow = 10 (ECHA default) (Ref I).


According to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/4447/00), use of daunorubicin is unlikely to represent a risk for the environment, because the predicted environmental concentration (PEC) is below the action limit 0.01 µg/L.


Predicted No Effect Concentration (PNEC)

Ecotoxicological studies

No data available.


Environmental Risk Classification (PEC/PNEC ratio)

Risk of environmental impact of daunorubicin cannot be excluded, since there is no data to calculate a PEC/PNEC ratio.


Degradation

No data available, hence the potential for persistence of daunorubicin cannot be excluded.


Bioaccumulation

Partitioning coefficient:

log Pow = 1.83 at neutral pH (experimentally determined with unknown method) (Ref II)


Justification of chosen bioaccumulation phrase:

Since log Pow < 4 at pH 7, daunorubicin has low potential for bioaccumulation.


Excretion (metabolism)

Of the dose absorbed 20% of the substance is excreted through urine. Metabolites identified are daunorubicinol (the main metabolite), daunorubicinol aglycone, deoxydaunorubicin aglycone, deoxydaunorubicinol aglycone, demethyl deoxydaunorubicinol aglycone, deoxydaunorubicinol aglycone 13-O-/3-glucuronide, demethyl deoxydaunorubicinol aglycone 4-0-sulfate, and demethyl deoxydaunorubicinol aglycone 4-O-$-glucuronide. The main metabolite is an active inhibitor of nucleic acid metabolism. (Ref III)


References

  1. ECHA, European Chemicals Agency, 2008 Guidance on information requirements and chemical safety assessment. https://echa.europa.eu/sv/guidance-documents/guidance-on-information-requirements-and-chemical-safety-assessment

  2. Hansch C., et al. 1995, Chem ID+, US National Library of Medicine, National Institute of Health. https://chem.nlm.nih.gov/chemidplus/chemidlite.jsp

  3. Takanashi S, Bachur NR. 1975. Daunorubicin metabolites in human urine. The Journal of Pharmacology and Experimental Therapeutics. 195(1): 41-49.

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