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Prasugrel

Information

Denna sammanfattande information kommer från Fass.

Persistens. Prasugrel bryts ned i miljön.
Bioackumulering. Prasugrel har låg potential att bioackumuleras.
Toxicitet. Prasugrel har måttlig kronisk toxicitet.
Risk. Användning av prasugrel (försäljningsdata Sverige 2016) har bedömts medföra försumbar risk för miljöpåverkan.

Detaljerad information

Utredningsrapport

Utredningsrapport för Efient (prasugrel) Doc.Ref.: EMEA/117561/2009.

"Environmental chemistry, fate and effects data were collected for prasugrel as recommended in the Guideline for environmental risk assessment of medicinal products for human use (CHMP/SWP/4447/00). The Phase I estimate of maximum exposure to all prasugrel residue in surface water predicted an exposure above the 0.01 µg/L and thus, a complete risk assessment (Phase II Tier A) according to the current guideline has been conducted. No likely risk has been identified with regard to aquatic organisms in either ground water or surface water, neither for sediment dwelling organisms."

"A complete environmental risk assessment has been conducted for prasugrel. No likely risk has been identified for aquatic organisms in either ground water or surface water, or for sediment dwelling organisms."

Fass miljöinformation

Fass miljöinformation för Efient från Daiichi Sankyo Nordics (hämtad 2021-01-19).

Fara

Persistens: "Because the calculated DT50 values from the total water-sediment systems were less than one day and because the hydrolysis of prasugrel is rapid (2,29 days or less), prasugrel is considered to be degraded in the environment."

Bioackumulation: "The log Kow was measured to be 2,27, 3,80, and 5,66 at pH values of 4, 7, and 9, respectively (Study 1982.6226, based on OECD 107). Prasugrel is an ionic compound for which the measured log Kow increases over the environmental range. The measured log Kow of prasugrel at pH 7 is less than 4 and, therefore, indicates that prasugrel is not expected to bioaccumulate in the environment. While log Kow is greater at higher pH values, prasugrel’s rapid degradation to more polar entities as well as its extensive metabolism to more polar metabolites, support the conclusion that prasugrel has low potential for bioaccumulation."

Kronisk toxicitet: Det finns data för 3 trofinivåer, känsligaste "Fathead minnow (Pimephales promelas) (OECD 210) NOEC 5 d embryos + 28 d larvae (mortality, growth) = 190 μg/L."

Risk

PEC/PNEC utgår från försäljningsdata i Sverige under år 2016. PEC/PNEC = 0,00001 vilket ger risken försumbar.

Författad vid avdelningen Kunskapsutveckling, Region Stockholm

Reviderat datum

[Helena Ramström 2021-01-19] Finns Fass-info från Daiichi Sankyo Nordics och finns utredningsrapporter. Inget i några mätrapporter. Ändrat revideratdatum 2016-03-31 till 2021-01-19 och datum för miljörisk 2013-01-01 till 2016-01-01.