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Alganex®

Miljöinformation
Receptstatus
Förmånsstatus
Meda

Tablett 20 mg
(6×12 mm, gulbeige, avlång, med skåra prägling '20')

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Delbarhetsinformation

Antiflogistikum med analgetisk och antipyretisk effekt

Aktiv substans:
ATC-kod: M01AC02
Utbytbarhet: Ej utbytbar
Läkemedel från Meda omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöinformation

Miljöpåverkan

Tenoxikam

Miljörisk: Risk för miljöpåverkan av tenoxikam kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning: Det kan inte uteslutas att tenoxikam är persistent, då data saknas.
Bioackumulering: Tenoxikam 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 = 0,00096 μg/L


Where:

A = 6,4004 kg (total amount API of tenoxicam in Sweden year 2017, data from IQVIA ) (Ref. 1)

R = removal rate = 0% (no data available)

P = number of inhabitants in Sweden = 9*106

V (L/day) = volume of waste water per capita and day = 200 (ECHA default) (Ref. 2)

D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (Ref. 2)


According to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/4447/00), use of Tenoxicam is unlikely to represent a risk for the environment, because the predicted environmental concentration (PEC) is below the action limit 0,01 μg/L.


Ecotoxicological studies

No ecotoxicological data available.


Degradation

No degradation data available.


Bioaccumulation

An estimated Log P of 2,40 (Ref. 3) indicates that Tenoxicam has low potential for bioaccumulation.


Log P < 4 which justifies use of the phrase “Tenoxicam has low potential for bioaccumulation”.


Excretion (metabolism)

Tenoxicam is almost completely metabolized, and only 0,5% is excreted as the unchanged substance through the urine. Up to two thirds of a given oral dose is excreted renally, mainly as the metabolite 5-hydroxytenoxicam, and the rest is excreted biliary. (Ref. 4)


References:

  1. Data from IQVIA ”Consumption assessment in kg for input to environmental classification” - updated 2018 (data 2017).

  2. ECHA, European Chemicals Agency. Guidance on information requirements and chemical safety assessment. Ver 2.1, 2011. http://echa.europa.eu/documents/10162/13643/information_requirements_r2_en.pdf

  3. Meylan WM and Howard PH (1995), ChemID+, US National Library of Medicin, National Institutes of Health, http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp

  4. SPC (Summary of Product Characteristics) for Alganex, 2017-05-08, www.FASS.se


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