Läs upp
För närvarande kan tillfälliga driftstörningar drabba fass.se. Problemet felsöks för närvarande.

FASS logotyp
Receptbelagd

Peka på symbolerna och beteckningarna till vänster för en förklaring.

Kontakt

Sök apotek med läkemedlet i lager

Sök lagerstatus

ProHance®

Miljöinformation
Receptstatus
Förmånsstatus
Bracco

Injektionsvätska, lösning 279,3 mg/ml
(klar, färglös till svagt gul lösning)

Paramagnetiskt kontrastmedel för magnetisk resonanstomografi (MRT)

Aktiv substans:
ATC-kod: V08CA04
Utbytbarhet: Ej utbytbar
Läkemedel från Bracco omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöinformation

Miljöpåverkan

Gadoteridol

Miljörisk: Risk för miljöpåverkan av gadoteridol kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning: Gadoteridol är potentiellt persistent.
Bioackumulering: Gadoteridol har låg potential att bioackumuleras.


Läs mer

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 = 0.00124 μg/L


Where:

A = 9.03 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)

Risk of environmental impact of gadoteridol 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 gadoteridol 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

Abiotic degradation

Hydrolysis:

Test results in <10 % degradation in 5 days.
(Protocol: OECD 111)
(Ref II)


Justification of chosen degradation phrase:

Gadoteridol fails to pass ready degradation test, hence the degradation phrase should be: Gadoteridol is potentially persistent.


Bioaccumulation

Partitioning coefficient:

Log Kow = -3.57 to -3.58 at pH 7 (experimentally determined by unknown method)
(Ref II)


Justification for chosen bioaccumulation phrase:

Since log Kow < 4 at pH 7, the substance has low potential for bioaccumulation.


Excretion (metabolism)

No biotransformation or degradation of gadoteridol has been demonstrated in vivo.

Gadoteridol is excreted in the urine in unchanged form. Within 24 hours, 94 % of the given dose is excreted.

(Ref III)


References

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

  2. Internal document: Gadoteridol Safety Data Sheet, version no 3, Bracco, revision date 2016-03-18.

  3. SmPC of ProHance, retrieved from MPA 2022-09-15; find here

Upp