Läs upp

Cookies

Den här webbplatsen använder så kallade cookies. Cookies är små textfiler som lagras i din dator och sparar information om olika val som du gjort på en webbsida – t ex språk, version och statistik – för att du inte ska behöva göra dessa val en gång till. Tekniken är etablerad sedan många år tillbaka och används idag på väldigt många webbplatser på Internet.

Du kan när som helst ändra cookieinställningarna för denna webbplats.

FASS logotyp
Receptbelagd

Peka på symbolerna och beteckningarna till vänster för en förklaring.

Kontakt och länkar

Sök apotek med läkemedlet i lager

Sök lagerstatus

Pulmicort®

MiljöinformationReceptstatusFörmånsstatus
AstraZeneca

Suspension för nebulisator 0,125 mg/ml
(vitaktig suspension)

Inflammationshämmande läkemedel för inhalation vid astma

Aktiv substans:
ATC-kod: R03BA02
Företaget omfattas av Läkemedelsförsäkringen
  • Vad är miljöinformation?

Miljöpåverkan (Läs mer om miljöpåverkan)

Budesonid

Miljörisk: Användning av budesonid har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning: Budesonid är potentiellt persistent.
Bioackumulering: Budesonid har låg potential att bioackumuleras.


Läs mer

Detaljerad miljöinformation

PEC/PNEC = 0.011/8.6 = 0.0013

PEC/PNEC ≤ 0.1


Environmental Risk Classification


Predicted Environmental Concentration ( PEC)


PEC is based on following data and calculated using the equation outlined in the fass.se guidance (Ref 1):


PEC (µg/L) = (A*109*(100-R))/(365*P*V*D*100)


PEC (µg/L) = 1.5*10-6*A*(100-R)


A (Kg/year)= 70.8 kg total sold amount API in Sweden year 2016, data from QuintilesIMS.

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

hydrolysis or biodegradation) = 0

P = number of inhabitants in Sweden = 9 *106

V (L/day) = volume of wastewater per capita and day = 200 (default, Ref 1)

D = factor for dilution of waste water by surface water flow = 10 (default, Ref 1)

(Note: The factor 109 converts the quantity used from kg to μg)


PEC = 1.5 * 10-6 *70.8 * (100-0) = 0.011 µg/L


Metabolism and excretion

After oral inhalation budesonide undergoes an extensive degree (>90%) of biotransformation to metabolites of low corticosteroid activity on first passage through the liver. The activity of the major metabolites, 6β-hydroxy-budesonide and 16α-hydroxy-prednisolone, is less than 1% of the parent compound. The plasma elimination half-life is approximately 4 hours. No or trace amounts of unchanged drug were found in the urine after intravenous administration (Ref 2).


Only trace amounts of budesonide are excreted unchanged in the urine of patients. As such, environmental exposure of budesonide resulting from patient use is expected to be negligible; however the PEC does not take into consideration metabolism and therefore provides a worst-case exposure senario.


PNEC (Predicted No Effect Concentration)


Ecotoxicity Data

Study Type

Method

Result

Reference

Toxicity to green algae, Pseudokirchinella subcapitata, growth inhibition test

OECD 201

72 hour NOEC (growth rate) = 5.6 mg/L

72 hour LOEC (growth rate) = 8.6 mg/L

72 hour EC50 (growth rate) > 8.6 mg/L

72 hour NOEC (biomass) = 5.6 mg/L

72 hour LOEC (biomass) = 8.6 mg/L

72 hour EC50 (biomass) > 8.6 mg/L

3

Acute toxicity to the giant water flea, Daphnia magna

OECD 202

48 hour EC50 (immobility) >14 mg/L

4

Acute toxicity to Rainbow Trout, Oncorhynchus mykiss

OECD 203

96 hour LC50 (mortality) > 13 mg/L

5

NOEC No Observed Effect Concentration

LOEC Lowest Observed Effect Concentration

EC50 the concentration of the test substance that results in a 50% effect

LC50 the concentration of the test substance that results in a 50% mortality


Environmental risk classification (PEC/PNEC ratio)

Short-term tests have been undertaken for species from three trophic levels, based on internationally accepted guidelines. For all three species, the EC50 values were greater than the highest test concentration and the limit of solubility of budesonide in the test medium. Therefore, to obtain a worst case PNEC value, the lowest limit of solubility of budesonide in the test media, reported for the algal study, is used. The PNEC is based on the lowest >EC50 value 8.6 mg/L (equivalent to 8600 µg/L) and an assessment factor of 1000 is applied, in accordance with ECHA guidance (Ref. 6).


PNEC = 8600 /1000 = 8.6 μg/L


Environmental risk classification (PEC/PNEC ratio)

PEC = 0.011 µg/L

PNEC = 8.6 µg/L

PEC/PNEC = 1.3 x 10-3


The Pec/PNEC ratio is < 0.1 which justifies the phrase "Use of budesonide has been considered to result in insignificant environmental risk".


In Swedish: “Användning av budesonid har bedömts medföra försumbar risk för miljöpåverkan” under the heading “Miljörisk”.


Environmental Fate Data


Environmental Fate Data for Budesonide

Study Type

Method

Result

Reference

Aerobic biodegradation

OECD301E

Degradation after 7 days <8 %

Not readily biodegradable

7


Degradation


Biotic degradation

Budesonide is not biologically readily biodegradable (Ref 7). Since data from further degradation tests is lacking, the phrase ‘Budesonide is potentially persistent’ is used under the heading Biodegradation.

In Swedish: ”Läkemedlet är potentiellt persistent” under the heading ”Nedbrytning”.


Bioaccumulation

Budesonide is not ionisable within the environmentally relevant pH range. The Log octanol-water partition coefficient is 3.3, measured at pH 7.4. Since Log P < 4, budesonide has low potential to bioaccumulate and the phrase “Budesonide has low potential for bioaccumulation” is assigned.


In Swedish: Budesonid har låg potential att bioackumuleras” under the heading ’Bioackumulering’.


Physical Chemistry Data


Study Type

Method

Result

Reference

Solubility Water 

Unknown

14 mg/L at 25oC

8

Octanol-Water Partition Coefficient

Unknown

Log Kow = 3.3

 

References

  1. Fass.se (2012). Environmental classification of pharmaceuticals at www.fass.se: Guidance for pharmaceutical companies https://www.fass.se/pdf/Environmental_classification_of_pharmaceuticals-120816.pdf.pdf  

  2. Investigator’s Brochure. Drug Substance Budesonide/formoterol. Project Code D5890000000. Edition Number 9. Date 31 May 2016.

  3. Budesonide: Toxicity to the green alga Selenastrum capricornutum. Bowles A.J. Brixham Environmental Laboratory Report BL8078/B. May 2005.

  4. Budesonide: Acute toxicity to Daphnia magna. Bowles A.J. Brixham Environmental Laboratory Report BL8079/B. May 2005.

  5. Budesonide: Acute toxicity to rainbow trout (Oncorhynchus mykiss). Bowles A.J. Brixham Environmental Laboratory Report BL8080/B. May 2005.

  6. ECHA (European Chemicals Agency) 2008. Guidance on information requirements and chemical safety assessment. Chapter R.10: Characterisation of dose [concentration]-response for environment http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm 

  7. Nedbrytbarhetsförhållanden för läkemedelssubstansen A002. Institutet för vatten- och luftvårdsforskning (IVL). IVL-rapport A92017. (Safety Assessment rapport SR99433-01).

  8. Budesonid - preformuleringsrapport. Report no. 83 – 014. Draco, Lund, Sweden. 1 February 1983.

Välj läkemedelstext
Hitta direkt i texten
Av