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Vaniqa

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) = 1.5*10-6*A(100-R)

¶ PEC = 0.00015*A

PEC = 0.00057 μg/L

Where:

A = 3.789 kg (total sold amount API in Sweden year 2017, data from IQVIA).

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

P = number of inhabitants in Sweden = 9 *106 

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

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


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.

Predicted No Effect Concentration (PNEC) 

No ecotoxicity study results are available.


Environmental risk classification (PEC/PNEC ratio)

The PEC/PNEC ratio cannot be calculated due to missing data, which justifies the phrase "Risk of environmental impact of eflornithine cannot be excluded since no ecotoxicity data are available."


Degradation

No degradation data is available, hence justifying the degradation phrase:

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


Bioaccumulation

Partitioning coefficient: 

Log Pow = -2.0 at neutral pH (estimated data, ALOGPS) (Ref II)

Justification of chosen bioaccumulation phrase:

Since log Pow < 4 at pH 7, eflornithine has low potential for bioaccumulation.


Excretion (metabolism)
Steady state cutaneous penetration of eflornithine from Vaniqa on facial skin of shaving women was 0.8%. The steady state plasma half-life of eflornithine was approximately 8 hours and steady state was reached within 4 days. The steady state peak of eflornithine was approximately 10 ng/ml. The steady state 12-hour area under the plasma concentration versus time curve was 92.5 ng.hr/ml. Eflornithine is not known to be metabolised and is eliminated primarily in the urine. (Ref III)


References

Ref I. ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment.

Ref II. Drug bank web page, assessed as of May 2019.
https://www.drugbank.ca/drugs/DB06243

Ref III. SPC text for Vaniqa at Fass.se, assessed as of May 2019.