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Orgalutran®

Organon Sweden

Injektionsvätska, lösning 0,25 mg/0,5 ml
(klar och färglös vattenlösning)

Anti-gonadotropinfrisättande hormon

Aktiv substans:
ATC-kod: H01CC01
Läkemedel från Organon Sweden omfattas av Läkemedelsförsäkringen.
Läkemedlet distribueras också av företag som inte omfattas av Läkemedelsförsäkringen, se Förpackningar.
  • Vad är miljöinformation?

Miljöinformation

Miljöpåverkan

Ganirelix

Miljörisk: Risk för miljöpåverkan av ganirelix kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning: Det kan inte uteslutas att ganirelix är persistent, då data saknas.
Bioackumulering: Ganirelix har hög 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 = 3.2 x 10-6 μg/L


Where:

A = 0.021 kg (total sold amount API in Sweden year 2019, data from IQVIA) (Ref. I)

R = 0 % removal rate (worst case assumption)

P = number of inhabitants in Sweden = 9 *106

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

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


Predicted No Effect Concentration (PNEC)


Ecotoxicological studies

No ecotoxicology studies are available for ganirelix and no PNEC can be determined.


Justification of chosen environmental risk phrase:

No data are available, therefore the phrase chosen for ganirelix is “Risk of environmental impact of ganirelix 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 ganirelix 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 studies

No degradation data are available for ganirelix.


Justification of chosen degradation phrase:

No data are available, therefore the phrase chosen for ganirelix is “The potential for persistence of ganirelix cannot be excluded, due to lack of data”.


Bioaccumulation

Estimated Log P = 5.4 (Computed by XLogP3 3.0 (PubChem release 2019.06.18)) (Ref. III)


Justification of chosen bioaccumulation phrase:

Since the estimated Log P > 4, the phrase chosen is “Ganirelix has high potential for bioaccumulation”.


References

  1. Data from IQVIA ”Consumption assessment in kg for input to environmental classification - updated 2020 (data 2019)”.


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


  3. PubChem, 2021. Ganirelix | C80H113ClN18O13 - PubChem (nih.gov), accessed 10 February 2021.