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Bimatoprost/Timolol Sandoz

Miljöinformation
Sandoz AS

Ögondroppar, lösning 0,3 mg/ml + 5 mg/ml
Avregistreringsdatum: 2020-11-23 (Tillhandahålls ej)

Aktiva substanser (i bokstavsordning):
ATC-kod: S01ED51
För information om det avregistrerade läkemedlet omfattas av Läkemedelsförsäkringen, kontakta Läkemedelsförsäkringen.
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Miljöinformation

Miljöpåverkan

Miljöinformationen för timolol är framtagen av företaget Novartis för AZARGA, DuoTrav

Miljörisk: Risk för miljöpåverkan av timolol kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning: Det kan inte uteslutas att timolol är persistent, då data saknas.
Bioackumulering: Timolol 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) = 1.37*10-6 * A * (100 - R) = 1.37*10-6 * 2.4 kg * 100 = 0.004142 μg/L = 4.1423 ng/L

Where:

A = 30.2354 kg (sum of 7.1842 kg timolol and 31.5077 kg timolol maleat, equaling 23.0512 kg timolol) (total sold amount API in Sweden year 2022, 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) (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 timolol 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 timolol cannot be excluded, due to lack of data.


Bioaccumulation

Partitioning coefficient:

logKow = 1.8 (method unknown) (Clarkes’s Analysis of Drugs and Poisons, 2017)

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 timolol: Timolol has low potential for bioaccumulation.


Excretion (metabolism)

Approximately 80% of timolol is metabolized in the liver to inactive metabolites. The unchanged drug and its metabolites are excreted in urine. Only small amounts of the drug are removed by hemodialysis. (AHFS Drug Information, 2017).


PBT/vPvB assessment

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


References

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