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Asacol

(Parallellimporterat)
Cross Pharma AB

Enterotablett 400 mg
Avregistreringsdatum: 2020-01-31 (Tillhandahålls ej)

Bisterkartan är märkt både OCTASA och Asacol.

Visa information om det parallellimporterade läkemedlet
Aktiv substans:
ATC-kod: A07EC02
För information om det avregistrerade läkemedlet omfattas av Läkemedelsförsäkringen, kontakta Läkemedelsförsäkringen.
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Miljöinformation

Miljöpåverkan

Miljöinformationen för mesalazin är framtagen av företaget Tillotts Pharma för Asacol, Asacol®

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


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Detaljerad miljöinformation

Mesalazin


Environmental risk: Risk of environmental impact of mesalazin cannot be excluded, since no ecotoxicity data are available.

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

Bioaccumulation: Mesalazin 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 (μg/L)=1,5 x 10–6 x 19944,77528 x 100= 2,99 μg/L. This assumes zero removal.


Where:


A = 19944,77528 kg total sold amount API in Sweden year 2016, data from QuintilesIMS (Ref. I). Reduction of A may be justified based on metabolism data.


R = X % 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. II)


D = factor for dilution of waste water by surface water flow = 10

(ECHA default) (Ref. II)


Predicted No Effect Concentration (PNEC)


There are no Ecotoxicity data available.


Environmental risk classification (PEC/PNEC ratio)


Justification to chosen risk classification phrase:

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


Degradation


Justification to chosen dagradation phrase:

The potential for persistence of mesalazin cannot be excluded, due to lack of data


Bioaccumulation


Partitioning coefficient (Ref. III)

Log Kow = 0.98 (est)


Justification of chosen bioaccumulation phrase:

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



References

  1. Data from Quintiles IMS ”Consumption assessment in kg for input to environmental classification - updated 2017”

  2. 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

  3. US EPA; Estimation Program Interface (EPI) Suite. Ver.3.12. Nov 30, 2004. Available from, as of Jan 4, 2007: http://www.epa.gov/oppt/exposure/pubs/episuitedl.htm