Miljöpåverkan (Läs mer om miljöpåverkan)
Siltuximab
Miljörisk:
Användning av aminosyror, proteiner och peptider bedöms inte medföra någon miljöpåverkan.
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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)