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Cholestagel

Sanofi AB

Filmdragerad tablett 625 mg
(benvit, oval märkt med C625 på en sida)

Serumlipidsänkande medel

Aktiv substans:
ATC-kod: C10AC04
Utbytbarhet: Ej utbytbar
Läkemedel från Sanofi AB omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöinformation

Miljöpåverkan

Kolesevelam

Miljörisk: Risk för miljöpåverkan av kolesevelam kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning: Det kan inte uteslutas att kolesevelam är persistent, då data saknas.
Bioackumulering: Kolesevelam har hög 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)


PEC = 0.028 µg/l


Where:
A = 186.525 kg (total sold amount API in Sweden year 2018, 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 = 9*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)


Predicted No Effect Concentration (PNEC)

Ecotoxicological studies

No ecotoxicity results available.


Environmental risk classification (PEC/PNEC ratio)
The PEC/PNEC ratio could not be calculated since there is no ecotoxicity data available, hence justifies the environmental risk phrase: "Risk of environmental impact of colesevelam cannot be excluded, since no ecotoxicity data are available."


Degradation

No data available, therefore justifying the phrase: "The potential for persistence of colesevelam cannot be excluded, due to lack of data."


Bioaccumulation

Partitioning coefficient:

Log Pow = 4.85 at pH 7 (estimated data) (Ref II, Estimation program ALOGPS: Ref III, IV and V).


Justification of chosen bioaccumulation phrase: Since log Pow < 4 at pH 7, colesevelam has high potential for bioaccumulation.


Excretion (metabolism)

No data available nor found in open sources.


References

  1. ECHA, European Chemicals Agency, 2008 Guidance on information requirements and chemical safety assessment. Available at https://echa.europa.eu/guidance-documents/guidance-on-information-requirements-and-chemical-safety-assessment2020-05-14.

  2. http://www.drugbank.ca/salts/DBSALT000790, retrieved 2020-05-14.

  3. http://www.vcclab.org/lab/alogps/, retrieved 2020-05-14.

  4. Tetko, I. V.; Tanchuk, V. Y. Application of associative neural networks for prediction of lipophilicity in ALOGPS 2.1 program, J. Chem. Inf. Comput. Sci., 2002, 42, 1136-1145.

  5. Tetko, I. V.; Tanchuk, V. Y.; Villa, A. E. Prediction of n-octanol/water partition coefficients from PHYSPROP database using artificial neural networks and E-state indices, J. Chem. Inf. Comput. Sci., 2001, 41, 1407-1421.