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Bunalict

Sandoz AS

Resoriblett, sublingual 2 mg/0,5 mg

narkotikaindikation Risk för tillvänjning föreligger.
Iakttag försiktighet vid förskrivning av detta läkemedel.

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Aktiva substanser (i bokstavsordning):
ATC-kod: N07BC51
Läkemedel från Sandoz AS omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöinformation

Miljöpåverkan

Naloxon

Miljörisk: Risk för miljöpåverkan av naloxon kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning: Det kan inte uteslutas att naloxon är persistent, då data saknas.
Bioackumulering: Naloxon 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 * 46.82 kg * 100

PEC = 0.007023 μg/L

Where:

A = 46.82 kg naloxone hydrochloride (total sold amount API in Sweden in year 2018, data from IQVIA / LIF).

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 naloxone 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 naloxone cannot be excluded, due to lack of data.’


Bioaccumulation

Partitioning coefficient:

logKow = 2.09 (method unknown) (DrugBank, 2019)

Justification of chosen bioaccumulation phrase:

Since log Kow is below 4, the following phrase is used: ‘Naloxone has low potential for bioaccumulation.’


Excretion (metabolism)

Naloxone is rapidly metabolized in the liver, principally by conjugation with glucuronic acid. The major metabolite is naloxone-3-glucuronide. Naloxone also undergoes N-dealkylation and reduction of the 6-keto group followed by conjugation. Limited studies with radiolabeled naloxone indicate that 25–40% of an oral or IV dose of the drug is excreted as metabolites in urine in 6 hours, about 50% in 24 hours, and 60–70% in 72 hours. (AHFS Drug Information, 2019)


References