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Plaquenil®

MiljöinformationReceptstatusFörmånsstatus
Sanofi AB

Filmdragerad tablett 200 mg
(vita, kupade, film­dragerade, märkta med HCQ på ena sidan och 200 på den andra, 9,7 mm)

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Aktiv substans:
ATC-kod: P01BA02
Utbytbarhet: Ej utbytbar
Läkemedel från Sanofi AB omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöpåverkan (Läs mer om miljöpåverkan)

Hydroxiklorokin

Miljörisk: Risk för miljöpåverkan av hydroxiklorokin kan inte uteslutas då det inte finns tillräckliga ekotoxikologiska data.
Nedbrytning: Det kan inte uteslutas att hydroxiklorokin är persistent, då data saknas.
Bioackumulering: Hydroxiklorokin 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)


PEC = 0.095 µg/L


Where:

A = 634.19 kg (total sold amount API in Sweden year 2017, 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*106

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)


Predicted No Effect Concentration (PNEC)

Ecotoxicological studies


Water flea, Daphnia magna:

EC50 24 h (immobilization) = 42 910 μg/L

Protocol: OECD 202

(Ref II)


EC50 24 h (immobilization) = 49 530 μg/L

Protocol: adapted from OECD protocol

(Ref III)


Other species:

EC50 (mortality) = 3 255 to 2 053 835 μg/L

Protocol: in vitro screening tests on various environmental species (Artemia Salina, Streptocephalus proboscideus, Brachionus calyciflorus, Photobacterium phosphoreum)

(Ref II)


Other ecotoxicity data:

The PNEC (μg/L) could not be calculated in the absence of sufficient ecotoxicity testing results.


Environmental Risk Classification (PEC/PNEC ratio)

Information available is insufficient to estimate the environmental risk by calculating the PEC/PNEC ratio, which justifies the phrase "risk of environmental impact of hydroxychloroquine cannot be excluded, since there is not sufficient ecotoxicity data available".



Degradation

Biotic degradation

No data available. Justification for degradation summary phrase: "The potential for persistence of hydroxychloroquine cannot be excluded, due to lack of data".


Abiotic degradation

Literature data indicates photochemical decomposition reactions. (Ref IV)


Bioaccumulation

Partitioning coefficient:

Log D (pH 7.4) = 0.62 (method: experimentally obtained by Sirius GLpK automated computerized potentiometric system) (Ref V)


Justification of chosen bioaccumulation phrase:

Since log D is < 4 at pH 7.4, the substance has low potential for bioaccumulation.


Excretion

The metabolism of chloroquine and hydroxychloroquine differs only in that the latter drug gives two first-stage metabolites, whereas chloroquine gives one. Oral absorption of both drugs in man is nearly complete. However, three times as much chloroquine as hydroxychloroquine appears in the urine, and three times as much hydroxychloroquine as chloroquine appears in the feces (Ref VI).

Chloroquine is extensively metabolized in the liver. Chloroquine and its metabolites are excreted in the urine with about half of a dose appearing as unchanged drug (Ref VII).


References

  1. ECHA, European Chemicals Agency, 2008 Guidance on information requirements and chemical safety assessment. http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm

  2. Calleja M.C., Persoone G. and Geladi P., 1993, The predictive potential of a battery of ecotoxicological tests for human acute toxicity, as evaluated with the first 50 MEIC Chemicals, ALTA Alternatives to Laboratory Animals, 21, 330-349.

  3. Lilius H, Isomaa B. and Holmström T., 1994, A comparison of the toxicity of 50 reference chemicals to freshly isolated rainbow trout hepatocytes and Daphnia magna, Aquatic toxicology, 30, 47-60.

  4. Tonnesen H., Grislingaas A.L., Woo S.O. and Karlsen J. 1988, Photochemical stability of antimalarials. I. Hydroxychloroquine, International Journal of Pharmaceutics, 43, 215-219.

  5. Warhurst, D.C. et al. Hydroxychloroquine is much less active against chloroquine-resistant Plasmodium falciparum, in agreement with its physicochemical properties. Journal of Antimicrobial Chemotherapy (2003) 52, 188 – 193.

  6. McChesney, E.W., 1983, Animal toxicity and pharmacokinetics of Hydroxychloroquine sulfate. American Journal of Medicine. 75: 1, 11-18.

  7. Product Information: ARALEN(R) oral tablet, chloroquine phosphate oral tablet, USP. Sanofi-Synthelabo Inc, New York, NY, 2003