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Primperan®

Sanofi AB

Tablett 10 mg
(vit med skåra, 7 mm)

Medel för behandling av nedsatt motilitet i mag-tarmkanalen samt mot illamående och kräkningar

Aktiv substans:
ATC-kod: A03FA01
Läkemedel från Sanofi AB omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöinformation

Miljöpåverkan

Metoklopramid

Miljörisk: Risk för miljöpåverkan av metoklopramid kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning: Det kan inte uteslutas att metoklopramid är persistent, då data saknas.
Bioackumulering: Metoklopramid 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 = 0.015 µg/L


Where:

A = 101.068 kg (total sold amount API in Sweden year 2016, data from QuintilesIMS)

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

P = number of inhabitants in Sweden = 10*106

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

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


Predicted No Effect Concentration (PNEC)

No ecotoxicity testing results are available.


Environmental Risk Classification (PEC/PNEC ratio)

A PEC/PNEC ratio cannot be calculated due to lack of data, hence justifying the phrase: "Risk of environmental impact of metoclopramide cannot be excluded, since no ecotoxicity data is available"


Degradation

No degradation data is available, thus justifying the degradation phrase: "The potential for persistence of metoclopramide cannot be excluded due to lack of data"


Bioaccumulation

Partition coefficient

Log Kow =2.62 at neutral pH (experimentally derived, method unknown) (Ref II)


Justification of chosen bioaccumulation phrase:

Since log Kow < 4 at pH 7, metoclopramide has low potential for bioaccumulation.


Excretion (metabolism)

Up to 80 % of an oral dose is excreted in the urine principally as unchanged drug and as glucuronide or sulfate conjugates of metoclopramide. About 5-10 % of an oral dose of metoclopramide is excreted in urine as 2-[(4-amino-5-chloro-2-methoxybenzoyl)amino] acetic acid and about 20 % is excreted unchanged. It is not known if this metabolite is pharmacologically active (Ref III)


References

  1. ECHA, European Chemicals Agency, 2008 Guidance on information requirements and chemical safety assessment. https://echa.europa.eu/guidance-documents/guidance-on-information-requirements-and-chemical-safety-assessment

  2. ChemIDPlus Lite. http://chem.sis.nlm.nih.gov/chemidplus/chemidlite.jsp

  3. Toxnet, Hazardous Substances Data Bank. http://toxnet.nlm.nih.gov/newtoxnet/hsdb.htm