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ProHance®

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.


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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*10 9 *(100-R))/(365*P*V*D*100) = 1.5*10 -6 *A*(100-R)


PEC = 0.0087 µg/L


Where:

A = 58.3 kg (total sold amount API in Sweden year 2018, data from IQVIA)

R = 0 % removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation)

P = number of inhabitants in Sweden = 9*10 6

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

D = factor of dilution of waste water by surface water flow = 10 (Ref I)


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.


Predicted No Effect Concentration (PNEC)

Ecotoxicological studies

No data available.


Environmental Risk Classification (PEC/PNEC ratio)

Risk of environmental impact of gadoteridol cannot be excluded, since there is no data to calculate a PEC/PNEC ratio.


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 K ow = -3.57 to -3.58 at pH 7 (Experimentally determined by unknown method) (Ref II)


Justification for chosen bioaccumulation phrase:

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


Excretion (Metabolism)

Gadoteridol is eliminated in the urine with 94.4 ± 4.8% (mean ± SD) of the dose excreted within 24 hours post-injection.

(Ref III)


References

  1. ECHA, European Chemicals Agency, 2008 Guidance on information requirements and chemical safety assessment. 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. Drug Bank Drug BankDate of information retrieval: 2017-03-17.