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Cuprior

Orphalan

Tablett 150 mg
(Gul, 16 mm x 8 mm ovala filmdragerade tabletter med en skåra på varje sida.)

Övriga medel för matsmältning och ämnesomsättning, övriga medel för matsmältning och ämnesomsättning

Aktiv substans:
ATC-kod: A16AX12
Utbytbarhet: Ej utbytbar
Läkemedel från Orphalan omfattas inte av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöinformation

Miljöpåverkan

Trientin

Miljörisk: Risk för miljöpåverkan av trientin kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning: Det kan inte uteslutas att trientin är persistent, då data saknas.
Bioackumulering: Det kan inte uteslutas att trientin kan bioackumuleras, då data saknas.


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Detaljerad miljöinformation


Environmental Risk Classification


Predicted Environmental Concentration (PEC)


PEC is based on following data:


PEC (µg/L) = (A*109*(100-R))/(365*P*V*D*100)


PEC (µg/L) = 1.5*10-6*A*(100-R)


A (kg/year) = forecasted sold amount API in Sweden the first three years after launch.

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

hydrolysis or biodegradation) = 0 if no data is available.

P = number of inhabitants in Sweden = 9*106
V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (Ref.1)

D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (Ref.1)

(Note: The factor 109 converts the quantity used from kg to μg).


A = The forecasted total sold amount of trientine tetrahydrochloride in Sweden the first three years after launch is estimated to be around 0.5 kg to 5 kg.

R =0


The below calculation of the PEC-value is based on the forecasted sold amount 0.5 kg ‑ 5 kg:

PEC minimum forecasted amount API sold = 1.5*10-6*0.5*(100-0) = 75*10-6 µg/L

PEC maximum forecasted amount API sold = 1.5*10-6*5*(100-0) = 750*10-6 µg/L


The theoretical interval of the PEC-value is between 75*10-6 µg/L - 750*10-6 µg/L, which indicates that the interval of the PEC-value is below the action limit 0.01 µg/L. According to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/4447/00), use of trientine tetrahydrochloride 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)


The risk of environmental impact of trientine tetrahydrochloride cannot be excluded, since no ecotoxicity data are available.


Degradation


The potential for persistence of trientine tetrahydrochloride cannot be excluded, due to lack of data.


Bioaccumulation


During the Phase I of the Environmental Risk Assessment (ERA), PBT screening regarding potential log Kow for trientine tetrahydrochloride was calculated to -1.4 and -2.65, but no experimentally value has ever been reported. Trientine tetrahydrochloride has 4 ionisable groups and is reported as completely miscible in water. With this in mind, the substance should not be expected to have a log Kow > 4. However, since there is no experimentally value for trientine tetrahydrochloride this justifies the assigned phrase “The potential for bioaccumulation of trientine tetrahydrochloride cannot be excluded, due to lack of data.” (Ref. 2)


References


  1. ECHA, European Chemicals Agency.

    October 2012 Version: 2.1 Guidance on information requirements and chemical safety assessment. 

    http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm

  2. EMA, European Medicines Agency. CHMP assessment report for Cuprior, 21 April 2017.

    https://www.ema.europa.eu/en/documents/assessment-report/cuprior-epar-public-assessment-report_en.pdf