Miljöpåverkan
Siltuximab
Miljörisk:
Användning av aminosyror, proteiner och peptider bedöms inte medföra någon miljöpåverkan.
Läs mer
Detaljerad miljöinformation
1. PREDICTED ENVIROMENTAL CONCENTRATION (PEC)
The Predicted Environmental Concentration is calculated according to the following formula:
PEC (µg/L) = A x 109 x (100-R) / 365 x P x V x D x 100
Where:
|
A (kg/year) |
= |
total actual API sales in Sweden for the most recent year 0.0601 kg (2017 – 2019 forecast) |
|
R (%) |
= |
removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation) |
|
|
= |
0% (worst-case scenario: no removal) |
|
P |
= |
number of inhabitants in Sweden (9 x 106) |
|
V (L/day) |
= |
volume of waste water per capita and day |
|
|
= |
200 (ECHA default) |
|
D |
= |
factor for dilution of waste water by surface water flow |
|
|
= |
10 (ECHA default) |
|
PEC (µg/L) |
= |
0.00001 µg/L |
2. PREDICTED NO EFFECT CONCENTRATION (PNEC)
According to the European Medicines Agency guideline on environmental risk assessments for pharmaceuticals (EMA/CHMP/SWP/4447/00), vitamins, electrolytes, amino acids, peptides, proteins, carbohydrates, lipids, vaccines and herbal medicinal products are exempted because they are unlikely to result in significant risk to the environment. [1]
2.1 Environmental risk classification (PEC/PNEC ratio)
Conclusion for environmental risk:
Use of amino acids/peptides/proteins has been considered to result in insignificant environmental impact.
3. REFERENCES
-
European Medicines Guideline on Environmental Risk Assessments for pharmaceuticals (EMA/CHMP/SWP/4447/00)