Meropenem

Detailed information

Fass environmental information

Fass environmental information for Meronem (meropenem) from Pfizer (downloaded 2023-12-19).

Hazard

Persistence: "Ready degradability (guideline OECD 301C). Not readily biodegradable. Meropenem did not pass the ready biodegradability test. Therefore, meropenem has received the FASS degradation phrase ”Meropenem is potentially persistent.”"

Bioaccumulation: Log P_OW at pH 7 = < -3.

Toxicity: There are data for 2 trophic levels, most sensitive blue-green alga (Anabaena flos-aquae) NOEC 15 microg/L.

Risk

"Based on the lowest NOEC for the species Anabaena flos-aquae and using the assessment factor of 10, the PNEC is calculated to 15/10 = 1.5 µg/L." PEC/PNEC is based on sales data in Sweden in year 2020. PEC = 0,0382 µg/L. PEC/PNEC = 0.025 which gives the risk insignificant. According to the regulatory at 2 trophic levels, the assessment factor would be 50. PEC/PNEC will then be 0.127 which gives the risk low.

Assessment report

Assessment report for meropenem from Vabomere (meropenem, vaborcaktam), 20 September 2018, EMA/CHMP/700663/2018.

"The applicant has not conducted a full ERA for meropenem. Although meropenem has not been previously authorised by the Centralised Procedure, it is currently authorised in 29 Member States of the European Economic Area through the Decentralized Procedure and no significant increase in environmental exposure in the EU is expected. This was considered acceptable by CHMP."

Other information

For antibiotics in general, it is recommended that these pharmaceuticals are used as restrictively as possible without jeopardise the patient's health.