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Opatanol

Miljöinformation
Receptstatus
Förmånsstatus
Novartis

Ögondroppar, lösning 1 mg/ml
(klar, färglös lösning)

Antiallergiskt medel för lokal behandling av allergisk konjunktivit

Aktiv substans:
ATC-kod: S01GX09
Utbytbarhet: Utbytbara läkemedel
Läkemedel från Novartis omfattas av Läkemedelsförsäkringen.
Läkemedlet distribueras också av företag som inte omfattas av Läkemedelsförsäkringen, se Förpackningar.
  • Vad är miljöinformation?

Miljöinformation

Miljöpåverkan

Olopatadin

Miljörisk: Risk för miljöpåverkan av olopatadin kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning: Det kan inte uteslutas att olopatadin är persistent, då data saknas.
Bioackumulering: Olopatadin 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) = 1.5*10-6 * 0.52425 kg * 100

PEC = 0.000079 μg/L

Where:

A = 0.52425 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) = 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) (ECHA 2008)

D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (ECHA 2008)


Predicted No Effect Concentration (PNEC)

Ecotoxicological studies

Algae: no data available


Crustacean (Daphnia magna): no data available


Fish: no data available


Other ecotoxicity data: No data available

PNEC derivation:

No PNEC can be calculated since there is no environmental toxicity data available 


Environmental risk classification (PEC/PNEC ratio)

Calculation of a risk ratio is not possible, due to the lack of environmental toxicity data. Therefore, the following phrase is used: "Risk of environmental impact of olopatadine cannot be excluded, since no ecotoxicity data are available."

Degradation 

Biotic degradation

Ready degradability: no data available

Justification of chosen degradation phrase:

As no data on biological degradation is available the following phrase is used: ‘The potential for persistence of olopatadine cannot be excluded, due to lack of data.’


Bioaccumulation

Partitioning coefficient:

logKow = 0.342 (method unknown) (Alcon Technical Report No. 090:38560:1093)

Justification of chosen bioaccumulation phrase:

As the logKow remains below the trigger level for a bioaccumlative substance (logKow < 4.0), the following statement is used for olopatadine: ‘Olopatadine has low potential for bioaccumulation.’


Excretion (metabolism)

Following topical application of olopatadine hydrochloride to the eyes, the plasma elimination half-life of the drug is about 3 hours.

Olopatadine is not extensively metabolized. Following oral administration, unchanged olopatadine accounts for 77% of peak plasma total radioactivity, while metabolites (e.g., olopatadine N-oxide, N-desmethyl olopatadine) account for less than 6%. The plasma elimination half-life of olopatadine following oral administration is 8–12 hours.

Olopatadine is eliminated principally by renal excretion; about 60–70% of a systemically absorbed dose of olopatadine is excreted in the urine (86% as unchanged olopatadine), and about 17% is excreted in feces. (AHFS Drug Information, 2017)


PBT/vPvB assessment

Based on screening information, olopatadine cannot be considered a potential PBT substance as the octanol-water partition coefficient remains significantly below the trigger level for a bioaccumulative substance.


References





 

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