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SYLVANT

EUSA Pharma (Netherlands)

Pulver till koncentrat till infusionsvätska, lösning 100 mg
(frystorkat vitt pulver)

Immunsuppressiva medel, interleukinhämmare

Aktiv substans:
ATC-kod: L04AC11
Utbytbarhet: Ej utbytbar
Läkemedel från EUSA Pharma (Netherlands) omfattas inte av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöinformation

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

  1. European Medicines Guideline on Environmental Risk Assessments for pharmaceuticals (EMA/CHMP/SWP/4447/00)