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Almogran

Meda

Filmdragerad tablett 12,5 mg
(vita, runda, bikonvexa, märkta på ena sidan med A, 6 mm)

Medel mot migrän

Aktiv substans:
ATC-kod: N02CC05
Läkemedel från Meda omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöinformation

Miljöpåverkan

Almotriptan

Miljörisk: Risk för miljöpåverkan av almotriptan kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning: Det kan inte uteslutas att almotriptan är persistent, då data saknas.
Bioackumulering: Almotriptan har låg potential att bioackumuleras.


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Detaljerad miljöinformation


Detailed background information


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 = 1,25 * 10-4 μg/L


Where:

A = 0,8351 kg (total amount API of almotriptan malate 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 Almotriptan 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

A computed Log Pow of 1,6 (XLogP3) (Ref. 3) indicates that Almotriptan has low potential for bioaccumulation.


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


Excretion (metabolism)

More than 75% of the administered dose is excreted via urine and the remainder via feces. Approximately 50% of excretion via urine and feces consists of unchanged Almotriptan. None of the metabolites are significantly pharmacologically active. (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

  3. National Center for Biotechnology Information. PubChem Compound Database; CID=123606

  4. SPC (Summary of Product Characteristics) Almotriptan, 2015-08-14