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Dabigatranetexilat

Fara 1 P 0 B 0 T 1 Risk Försumbar

Information

T-värdet i faropäng avser kronisk toxicitet. Underliggande data för P, B, T och risk kommer från Fass.

Utredningsrapport

Utredningsrapport för Pradaxa (dabigatranetexilat) EMEA/174363/2008 från 2008.

Fara

Persistens: "It was expected that DAB (dabigatran, red. anm.) will disappear rapidly from aerobic aquatic systems mainly via binding to sediment and formation of several minor metabolites (OECD 308). The level of 14C-DAB in the sediment reached a plateau between days 3 and 14 with a maximal detected value of 5.7%. However, due to the structural resemblance to not ready biodegradable substances, a tier B study on transformation in aquatic sediment systems was performed (OECD 308)." Se vidare under rubriken Risk.

Bioackumulation: "Log Kow for DAB was below 4.5 thus a screening for persistence, bioaccumulation and toxicity was not needed."

Toxicitet: Inga data.

Risk

"The calculated PEC/PNEC ratios were all below 1. In summary, due to the low risk further testing in for effects on the aquatic environment, microorganisms and the terrestrial compartment were not required. In addition, due to the low Kow a bioaccumulation study was not needed. PECsediment values were obtained for EU (0.453 μg/kg) and the “worst-case scenario” France (0.718 μg/kg). Since the PEC/PNEC ratio for the sediment was clearly below 1, it was concluded that with the present use pattern, DAB constitutes an insignificant risk for the sediment compartment. In conclusion, it is unlikely that DAB use will result in an environmental risk."

Fass miljöinformation

Fass miljöinformation för Pradaxa från Bayer (hämtad 2019-10-14).

Fara

Persistens: "OECD Guideline 308 study showed, in accordance with FASS criteria (IV), 50% dissipation times (DT50) of ≤ 32days, where Dabigatran rapidly and strongly binds to sediment. Extraction with acetonitrile/water did not significantly affect the amount of extractable substance, though extraction with acetonitrile/HCL under reflux conditions did increase the amount of extractable substance, however this is not considered environmentally relevant. Based on these data Dabigatran etexilate is considered “degraded in the environment”."

Bioackumulation: "Log Kow of < -2.2 at pH 7 was determined for Dabigatran in an OECD 107 study with no pH dependency between pH 5 to 9."

Kronisk toxicitet: Det finns data för 3 trofinivåer, känsligaste kräftdjur (Daphnia magna, 21 dagar, dödlighet) NOEC 1,0 mg/L.

Risk

PEC/PNEC utgår från försäljningsdata i Sverige under år 2016. PEC/PNEC = 0,0013, vilket ger risken försumbar.

Författad vid avdelningen Strategiska vårdgivarfrågor, Region Stockholm

Reviderat datum

2019-10-14

[Helena Ramström 2019-10-14] Finns miljöinfo från Bayer och finns utredningsrapport om Pradaxa. Inget i några mätrapporter. Risken 2 asterisk ändrad till 1 (finns data för kronisk toxicitet för 3 trofinnivåer). Ändrat reviderat datum från 2016-03-29 till 2019-10-14 och ändrat datum för miljörisk från 2011-01-01 till 2019-10-14.