Miljöpåverkan
Miljöinformationen för moklobemid är framtagen av företaget Meda för Aurorix®
Miljörisk:
Risk för miljöpåverkan av moklobemid kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att moklobemid är persistent, då data saknas.
Bioackumulering:
Moklobemid har låg potential att bioackumuleras.
Läs mer
Detaljerad miljöinformation
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 = 4.824*10-3 μg/L
Where:
A = 35.2142 kg (total amount API of moclobemide in Sweden year 2022, data from IQVIA) (Ref. 1)
R = removal rate = 0% (no data available)
P = number of inhabitants in Sweden = 10*106
V (L/day) = volume of waste water per capita and day = 200 (ECHA default) (Ref. 2)
D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (Ref. 2)
According to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/4447/00), use of * name of the substance* is unlikely to represent a risk for the environment, because the predicted environmental concentration (PEC) at the time of registration was below the action limit 0.01 μg/L.
Ecotoxicological studies
No ecotoxicological data available.
Degradation
No degradation data available.
Bioaccumulation
Estimated Log Pow values of 1.56 (ALOGPS) and 1.45 (ChemAxon) (Ref. 3) indicates that moclobemide has low potential for bioaccumulation.
Log Pow < 4 which justifies use of the phrase “Moclobemide has low potential for bioaccumulation”.
Excretion (metabolism)
Less than 1% of given dose of moclobemide is found in unhanged form in the urine. (Ref. 4)
References:
-
Data from IQVIA ”Consumption assessment in kg for input to environmental classification - updated 2021 (data 2022)”.
-
ECHA, European Chemicals Agency. Guidance on information requirements and chemical safety assessment. Ver 2.1, 2011.
-
DrugBank, Drug and Drug Target Database, www.drugbank.ca
-
SPC (Summary of Product Characteristics) for Aurorix, 2014-08-19, www.fass.se