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Atarax

UCB Nordic

Filmdragerad tablett 10 mg
(vita, runda)

Lugnande medel

Aktiv substans:
ATC-kod: N05BB01
Läkemedel från UCB Nordic omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöinformation

Miljöpåverkan

Hydroxizin

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


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Detaljerad miljöinformation

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 = 0.14 μg/L


Where:

A = 900.44661 kg (total sold amount API in Sweden year 2017, data from IQVIA).

R = removal rate = 0 % (no data available), assuming zero removal (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 waste water per capita and day = 200 (ECHA default) (Ref I)

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


Predicted No Effect Concentration (PNEC)

Ecotoxicological studies

No ecotoxicity data is available.


Environmental risk classification (PEC/PNEC ratio)


Since no ecotoxicity data is available the PEC/PNEC cannot be calculated, hence justifying the environmental risk classification phrase: "Risk of environmental impact of hydroxyzine cannot be excluded, since no ecotoxicity data are available".


Degradation

No degradation data is available therefore the degradation phrase should be:"The potential for persistence of hydroxyzine cannot be excluded, due to lack of data".


Bioaccumulation

Partitioning coefficient:

An experimentally derived Log Kow of 2.58 at neutral pH (method unknown) (Ref II)


Since Log Kow < 4 at pH 7, hydroxyzine has low potential for bioaccumulation, justifying the phrase: “Hydroxizin has low potential for bioaccumulation”.


Excretion (metabolism)

Hydroxyzine is excreted to < 1 % as parent compound. The most important

metabolite cetirizine is active (also a H1 antagonist with potency assumed

similar to mother compound) and eliminated intact in urine corresponding

to 25 % of the mother compound. (Ref III)


References

  1. ECHA, European Chemicals Agency. 2016. Guidance on information requirements and chemical safety assessment . Available at: https://echa.europa.eu/guidance-documents/guidance-on-information-requirements-and-chemical-safety-assessment

  2. UCB Pharma Material Safety Data Sheet, Document number: RSDE02F2707,

    2007-06-01

  3. SPC (Summary of Product Characteristics) Atarax, UCB Nordic.