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Recordati

Kapsel, hård 1340 mikrog
(Tillhandahålls ej) (Hård kapsel med en ljusgul opak överdel och en ljusgul opak underdel, som är märkt ”TIVZ” på överdelen med mörkblått bläck och ”SD” på underdelen med mörkblått bläck.)

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Antineoplastiska medel, proteinkinashämmare

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ATC-kod: L01EK03
Utbytbarhet: Ej utbytbar
Läkemedel från Recordati omfattas av Läkemedelsförsäkringen.
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Miljöinformation

Miljöpåverkan

Tivozanib

Miljörisk: Risk för miljöpåverkan av tivozanib kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning: Det kan inte uteslutas att tivozanib är persistent, då data saknas.
Bioackumulering: Det kan inte uteslutas att tivozanib kan bioackumuleras, då data saknas.


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Detaljerad miljöinformation


Detailed background information


Environmental Risk Classification


Predicted Environmental Concentration (PEC)


PEC is based on following data:


PEC (µg/L) = (A*109*(100-R))/(365*P*V*D*100)


PEC (µg/L) = 1.5*10-6*A*(100-R)


A (kg/year) = The forecasted total sold amount of tivozanib in Sweden 2021.


R (%) = 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 = 9 *106
V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (Ref. 1)

D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (Ref. 1)

(Note: The factor 109 converts the quantity used from kg to μg).


A = The total sold amount of tivozanib in Sweden year 2021 is estimated to be around 0,06867 kg.

R =0


PEC = 1.5 * 10-6 * 0,06867 *(100-0)= 10,3 x 10-6 µg/L


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


Predicted No Effect Concentration (PNEC)

The risk of environmental impact of tivozanib cannot be excluded, since no ecotoxicity data are available.


Degradation

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


Bioaccumulation

Partitioning coefficient:

A log Kow value of 4.09 at 40°C has been calculated by HPLC method and demonstrated to be below 4.5 (action limit for PBT screening); however these available data do not allow a definite conclusion on the potential risk of this substance to the environment. (Ref. 2)


Justification of chosen bioaccumulation phrase:

The potential for bioaccumulation of tivozanib cannot be excluded, due to lack of data.


References

  1. ECHA, European Chemicals Agency.

    October 2012 Version: 2.1 Guidance on information requirements and chemical safety assessment.

    http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm

  2. European Medicines Agency.

    Fotvida assessment report, EMA/CHMP/437168/2017, 22 June 2017. https://www.ema.europa.eu/en/documents/assessment-report/fotivda-epar-public-assessment-report_en.pdf

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