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Orion Pharma

Filmdragerad tablett 50 mg/12,5 mg/200 mg
(Tillhandahålls ej)

ATC-kod: N04BA03
Läkemedel från Orion Pharma omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöinformation

Miljöpåverkan

Miljöinformationen för levodopa är framtagen av företaget MSD för Sinemet®, Sinemet® Depot, Sinemet® Depot Mite

Miljörisk: Användning av levodopa har bedömts medföra låg risk för miljöpåverkan.
Nedbrytning: Det kan inte uteslutas att levodopa är persistent, då data saknas.
Bioackumulering: Levodopa har låg potential att bioackumuleras.


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Detaljerad miljöinformation

Levodopa


Environmental risk: Use of levodopa has been considered to result in low environmental risk.

Degradation: The potential for persistence of levodopa cannot be excluded, due to lack of data.

Bioaccumulation: Levodopa has low potential for bioaccumulation


Detailed background information


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) = 1.5*10-6*A(100-R)


PEC = 0.65 μg/L


Where:

A = 4329 (total sold amount API in Sweden year 2016, data from QuintilesIMS).

R = 0 % removal rate (worst case assumption)

P = number of inhabitants in Sweden = 9 *106

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

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


Predicted No Effect Concentration (PNEC)


Ecotoxicological studies

Green algae (Pseudokirchneriella subcapitata) (OECD 201) (Ref. II):

EC50 72 h (growth rate) ~ 4.4 mg/L

EC50 72 h (yield) = 1.5 mg/L

NOEC 72 h (yield) = 0.32 mg/L


Crustacean, water flea (Daphnia magna) (OECD 202) (Ref. III):

Acute toxicity

EC50 48 h (immobility) = 16 mg/L


Fish, rainbow trout (Oncorhynchus mykiss) (OECD 203) (Ref. II):

Acute toxicity

LC50 72 h (mortality) > 100 mg/L


PNEC = 1.5 μg/L (1500 µg/L / 1000 based on the most sensitive acute EC50 for the green algae and an assessment factor (AF) of 1000)


Environmental risk classification (PEC/PNEC ratio)

PEC/PNEC = 0.65/1.5 = 0.43, i.e. 0.1 < PEC/PNEC ≤ 1 which justifies the phrase "Use of levodopa has been considered to result in low environmental risk."


Degradation

There are no data on the degradability of levodopa, therefore, the potential for persistence cannot be excluded.


Bioaccumulation

Partitioning coefficient (Method unknown) (Ref. IV):

Log Kow = -2.39


Justification of chosen bioaccumulation phrase:

Since log Kow < 4 the substance has low potential for bioaccumulation



References

  1. ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment. http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm

  2. Roche, 2013. “Safety Data Sheet for MADOPAR Tablets 50/12.5 mg”, accessed on 1 Feb 2018 via http://www.roche-australia.com/content/dam/roche_australia/en_AU/files/SDS/MADOPAR_sds.pdf on 23 April 2015.

  3. ICI Brixham, 1988. "LEVODOPA: Determination of the Acute Toxicity to Daphnia Magna." Study No. BL/B/3276, Brixham, UK, 27 May 1988.

  4. Sangster, J., 1993. “Log Kow Databank”, Sangster Res. Lab. Montreal, Quebec, Canada.