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Desferal®

Novartis

Pulver till injektions-/infusionsvätska, lösning 500 mg

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ATC-kod: V03AC01
Läkemedel från Novartis omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöinformation

Miljöpåverkan

Deferoxamin

Miljörisk: Risk för miljöpåverkan av deferoxamin kan inte uteslutas då det inte finns tillräckliga ekotoxikologiska data.
Nedbrytning: Deferoxamin bryts ned i miljön.
Bioackumulering: Deferoxamin har låg potential att bioackumuleras.


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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) =0.0038

PEC = 0.0038 μg/L

Where:

A = 25.52682 kg deferoxamine mesylate (total amount of API sold in Sweden in 2018, data from IQVIA

R = 0 % removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis, or biodegradation)

P = number of inhabitants in Sweden = 9 ×106 

V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (ECHA 2008)

D = factor for dilution of wastewater by surface water flow = 10 (ECHA default) (ECHA 2008)


Predicted No Effect Concentration (PNEC)

Ecotoxicological studies

Algae (Selenastrum capricornutum): no data available


Crustacean (Daphnia magna, waterflea):

Acute toxicity

EC50 48 h (immobilisation) > 100.0 mg/L (OECD 202) (Ciba-Geigy Project No. 95N021)


Fish (Danio rerio, zebrafish):

Acute toxicity

LC50 96 h (mortality) > 1000.0 mg/L (OECD 203) (Ciba-Geigy Ecotoxicology department Project No. 821478)


Other ecotoxicity data:

Bacterial Respiration Inhibition:

IC20 3 h > 100.0 mg/L (activated sludge respiration inhibition, OECD209) (Ciba-Geigy Project No.95G037)


PNEC Derivation:

No PNEC can be calculated since there is only environmental toxicity data from two trophic levels available. 


Environmental risk classification (PEC/PNEC ratio)

No PNEC can be calculated since there is not sufficient environmental toxicity data available. Therefore, the following phrase is used: “Risk of the environmental impact of deferoxamine cannot be excluded, since there is not sufficient ecotoxicity data available.” 

However, according to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/44447/00 corr2), the use of Deferoxamine is unlikely to represent a risk for the environment, because the predicted environmental concentration (PEC) is below the action limit 0.01 μg/L.


Degradation 

Biotic degradation

Ready degradability:

69 % degradation in 28 days, readily biodegradable (OECD 301B) (Ciba-Geigy Project No. 90.2349)


Justification of chosen degradation phrase:

Desferrioxamine passes the criteria for ready biodegradation. The phrase “Deferoxamine is degraded in the environment” is thus chosen.


Bioaccumulation

Partitioning coefficient:

Log Kow < -3.0 (20 °C, method unknown).

Justification of chosen bioaccumulation phrase:

Since log Kow < 4, deferoxamine has a low potential for bioaccumulation.


Excretion (metabolism)

Both desferrioxamine DFO and ferrioxamine (FO) have biphasic elimination after intramuscular injection in healthy volunteers; for DFO the apparent distribution half-life is 1 hour, and for FO 2.4 hours. The apparent terminal half-life is 6 hours for both. Within six hours of injection, 22 % of the dose appears in the urine as DFO and 1 % as FO. (DESFERAL® (desferrioxamine) Core Data Sheet) 


PBT/vPvB assessment

Based on the available information, desferrioxamine does not fulfill the screening criteria for a persistent or bioaccumulative substance and can therefore not be considered a potential PBT substance.


References

  • ECHA 2008, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment. http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm

  • Ciba-Geigy Project No. 95N021. No full reference available.

  • Ciba-Geigy Ecotoxicology department Project No. 821478. No full reference available.

  • Ciba-Geigy Project No.95G037. No full reference available.

  • Ciba-Geigy Project No. 90.2349, 21.11.1990. No full reference available.

DESFERAL® (desferrioxamine) Core Data Sheet. Version 2.0., 30 September 2014.