Pramipexol

Detaljerad information

Fass miljöinformation

Fass miljöinformation för Mirapexin (pramipexol) från Boehringer Ingelheim (hämtad 2023-03-01).

Fara

Persistens: "Aerobic degradation (US-FDA, TAD 3.11) ... 3.5% mineralization in 28 days 80% primary degradation in 28 days (estimated 50% degradation in 17 days).

Aquatic photodegradation half-life ...
pH 5 = 346 hours
pH 7 = 55,5 hours
pH 9 = 33,1 hours

Justification: Pramipexole is degraded photolytically over the range of pH likely to be encountered in the environment indicating that it is readily degraded. However although the aerobic degradation results indicate that significant biodegradation did occur, as 80% of the compound was degraded during the test period, significant mineralization did not occur and pramipexole did not pass the 10 day criteria. The phrase “Pramipexole is potentially persistent” is therefore used."

Bioackumulation: OECD 107: pH 7 : log D = -1,0. "Justification: Since log D < 4 at pH 7, “Pramipexole has low potential for bioacculumation."

Akut toxicitet: Det finns data för 3 trofinivåer, känsligaste kräftdjur (Daphnia magna) (OECD 202) "EC₅₀ 48 h (immobilization)" 70 000 mikrog/L.

Risk

PEC/PNEC utgår från försäljningsdata i Sverige under år 2021. PEC/PNEC = 0,00001 vilket ger risken försumbar.

Utredningsrapport Oprymea

Utredningsrapport för Oprymea (pramipexol) 19 September 2013, EMA/703661/2013.

"No Environmental Risk Assessment (ERA) was submitted. This was justified by the applicant as the introduction of Oprymea manufactured by Krka d.d. Novo mesto is considered unlikely to result in any significant increase in the combined sales volumes for all pramipexole containing products and the exposure of the environment to the active substance. Thus, the ERA is expected to be similar and not increased."

Utredningsrapport Pramipexole Accord

Utredningsrapport för Pramipexole Accord, London, 21 July 2011, EMA/816841/2011.

"No Environmental Risk Assessment (ERA) was submitted. This was justified by the applicant as the introduction of Pramipexole Accord manufactured by Accord Healthcare Limited is considered unlikely to result in any significant increase in the combined sales volumes for all pramipexole containing products and the exposure of the environment to the active substance. Thus, the ERA is expected to be similar and not increased."

Kommentar om miljöinformation på EMA:s webbplats

Ingen miljöinformation om pramipexol har dock återfunnits på EMA:s webbplats (2023-03-01).