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Vaniqa

Miljöinformation
Receptstatus
Förmånsstatus
Almirall

Kräm 11,5 %
(vit till benvit)

Övriga dermatologiska medel

Aktiv substans:
ATC-kod: D11AX16
Utbytbarhet: Ej utbytbar
Läkemedel från Almirall omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöinformation

Miljöpåverkan

Eflornitin

Miljörisk: Risk för miljöpåverkan av eflornitin kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning: Det kan inte uteslutas att eflornitin är persistent, då data saknas.
Bioackumulering: Eflornitin 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) = 1.37*10-6*A(100-R)


PEC = 0.00023 μg/L


Where:

A = 1.67 kg (total sold amount API in Sweden year 2020, data from IQVIA).

R = 0 % removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation) = 0 if no data is available.

P = number of inhabitants in Sweden = 10 *106

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

D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (Ref. I)

Predicted No Effect Concentration (PNEC)

Ecotoxicological studies

No data is available.


Environmental risk classification (PEC/PNEC ratio)

It is not possible to calculate the environmental risk classification (PEC/PNEC ratio) due to lack of data.


Summary phrases for the environmental risk:

Risk of environmental impact of eflornithine cannot be excluded, since no ecotoxicity data are available.


According to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/4447/00), use of eflornithine is unlikely to represent a risk for the environment, because the predicted environmental concentration (PEC) is below the action limit of 0.01 μg/L.

Degradation

No degradation data is available.


Summary phrases for degradation:

The potential for persistence of eflornithine cannot be excluded, due to lack of data.


Bioaccumulation

Partitioning coefficient: 

LogP = -2.0 (estimated data, pH unknown (source ALOGPS))

(Ref II)


Justification of chosen bioaccumulation phrase:

Since logP < 4, eflornithine has low potential for bioaccumulation.


Excretion (metabolism)
Eflornithine is not known to be metabolised and is eliminated primarily in the urine.
(Ref III)


References

  1. ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment; find here

  2. Drug bank web page, assessed as of March 2022; find here

  3. SmPC text for Vaniqa via MPA, assessed as of March 2022; find here


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