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Företaget deltar inte i Fass, därför finns endast begränsad information om läkemedlet.

Octasa

(Parallellimporterat)
Orifarm AB

Enterotablett 800 mg
Avregistreringsdatum: 2019-12-31 (Tillhandahålls ej)

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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) = 1.37*10-6*A(100-R)


PEC (μg/L) = 1,37 x 10–6 x 37 011,7914 x 100= 5,07 μg/L. This assumes zero removal.


Where:


A = 37 011,7914 kg total sold amount API of mesalazine in Sweden year 2022, data from IQVIA (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 = 10*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 IQVIA ”Consumption assessment in kg for input to environmental classification v1 - updated 2023 (data 2022)”.

  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

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