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Onbrez® Breezhaler®

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Novartis

Inhalationspulver, hård kapsel 150 mikrog
(Kapslarna är genomskinliga (ofärgade) och innehåller ett vitt pulver, med ”IDL 150” tryckt i svart ovanför ett svart streck, och en svart företagslogotyp tryckt nedanför det svarta strecket.)

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Långverkande beta2-agonister

Aktiv substans:
ATC-kod: R03AC18
Utbytbarhet: Utbytbara läkemedel
Läkemedel från Novartis omfattas av Läkemedelsförsäkringen.
Läkemedlet distribueras också av företag som inte omfattas av Läkemedelsförsäkringen, se Förpackningar.
  • Vad är miljöinformation?

Miljöinformation

Miljöpåverkan

Indakaterol

Miljörisk: Användning av indakaterol har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning: Indakaterol är potentiellt persistent.
Bioackumulering: Indakaterol 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) = 1.37*10-6 * A * (100 - R) = 1.37*10-6 * 0.4935 kg * 100 = 0.000068 μg/L = 0.0676 ng/L


Where:

A = 0.4935 kg indakaterol maleat (total sold amount API in Sweden year 2023, data from IQVIA).

R = 0 % removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation) = 0, if no data is available.

P = number of inhabitants in Sweden = 10 * 106

V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (ECHA 2008)

D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (ECHA 2008)


Predicted No Effect Concentration (PNEC)

Ecotoxicological studies

Algae (Desmodesmus subspicatus) (92/69/EC (L383) C.3) (CETA Study Nr.: 37/02/23, Report Nr. 1803/L):

EC50 72 h (growth rate) > 100.0 mg/L


Crustacean (Daphnia magna, waterflea):

Acute toxicity

EC50 48 h (immobilization) > 100.0 mg/L (92/69/EEC (L.383) C.2) (CETA Study Nr.: 1/03/22, Report Nr. 2066/L)


Fish:

Acute toxicity (Piecilia reticulata, guppy)

LC50 96 h (mortality) > 100.0 mg/L (OECD203) (CETA Study Nr.: 37/02/21, Report Nr. 1807/L)


Other ecotoxicity data:

Bacterial respiration inhibition

EC50 3 h > 300.0 mg/L (activated sludge respiration inhibition) (87/302/EEC Part C) (ARC Study No.: NOV30)


PNEC derivation:

PNEC = 100.00 μg/L

PNEC (μg/L) = lowest EC50/1000, where 1000 is the assessment factor used, based on the fact that three acute toxicity studies are available, covering three trophic levels. An EC50 of 100 mg/L is used for this calculation, based on the fact that no acute toxic effects were observed in fish, Daphnia and algae at the highest tested concentration of 100.0 mg/L.


Environmental risk classification (PEC/PNEC ratio)

PEC/PNEC = 0.000068 μg/L / 100.0 μg/L = 0.00000068, i.e. PEC/PNEC ≤ 0.1 which justifies the phrase "Use of indacaterol has been considered to result in insignificant environmental risk."


Degradation

Biotic degradation

Ready degradability:

0 % degradation in 28 days, not readily biodegradable (OECD301D). (CETA Study Nr.: 37/02/25, Report Nr.: 1811/L)


Justification of chosen degradation phrase:

Indacaterol is not readily biodegradable. Therefore, the phrase "Indacaterol is potentially persistent" is chosen.


Bioaccumulation

Partitioning coefficient:

Log P = -0.74 at 20.1°C (EC440/2008 A.8 8). (NOTOX Project 491643)


Justification of chosen bioaccumulation phrase:

Since log P < 4, indacaterol has low potential for bioaccumulation.


Excretion (metabolism)

In clinical studies which included urine collection, the amount of indacaterol excreted unchanged via urine was generally lower than 2% of the dose. In a human ADME study where indacaterol was given orally, the fecal route of excretion was dominant over the urinary route. Indacaterol was excreted into human feces primarily as unchanged parent drug (54% of the dose) and, to a lesser extent, hydroxylated indacaterol metabolites (23% of the dose). (Novartis Core Data Sheet Onbrez® Breezhaler®).


PBT/vPvB assessment

Indakaterol has low potential for bioaccumulation. Indakaterol can therefore not be considered a potential PBT substance.


References

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

  • CETA Study Nr.:37/02/23, Report Nr. 1803/L. Alga, growth inhibition test. Final report: 15.09.2004

  • Study No.: 1/03/22, Report No.: 2066/L. Daphnia, acute immobilisation test. Final report: 15.09.2004

  • CETA Study Nr: 1807/L, Report Nr.: 37/02/21. Fish, acute toxicity test. Final report: 15.09.2004

  • Study project Nr.: NOV30, Report No: ARC- -UL-0561. Activated sludge respiration inhibition test. Final report: November 2002.

  • CETA Study Nr.: 37/02/25, Report Nr.: 1811/L. Determination of ready biological degradability - closed bottle test. Final report:15.09.2004.

  • NOTOX Project 491643. Determination of physico-chemical properties of indacatarol maleate. Final report: 21.08.2009.

  • Novartis Core Data Sheet Onbrez® Breezhaler® and related products (indacaterol maleate). Version 2.1. 30. September 2013.

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