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Aclasta®

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Novartis

Infusionsvätska, lösning 5 mg
(Klar, färglös lösning)

Läkemedel för behandling av bensjukdomar, bisfosfonater

ATC-kod: M05BA08
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  • Vad är miljöinformation?

Miljöpåverkan (Läs mer om miljöpåverkan)

Zoledronsyra (vattenfri)

Miljörisk: Användning av zoledronsyra har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning: Zoledronsyra bryts ned i miljön.
Bioackumulering: Zoledronsyra 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 * 0.1426 * 100

PEC = 0.00002139 μg/L

Where:

A = 0.1426 kg (total sold amount API in Sweden year 2015, data from IMS Health).

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 = 9 *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 (Selenastrum capricornutum) (92/69/EC (L383) C.3) (NOTOX Project 230107):

EC50 72 h (growth rate) = 15.0 mg/L

NOEC = 2.2 mg/L


Crustacean (Daphnia magna):

Acute toxicity

EC50 48 h (immobilisation) > 18 mg/L maximum testing concentration due to limited water solubility of zoledronic acid (92/69/EEC (L383) C.2) (NOTOX Project 230118)

Chronic toxicity

NOEC 21 days (growth: body length) = 0.38 mg/L (OECD 211) (Springborn Smithers Study 1096.006.230)


Fish (Pimephales promelas, fathead minnow):

Chronic toxicity

NOEC 32 days (growth: body length and dry weight) = 0.31 mg/L (OECD 210) (Springborn Smithers Study 1096.006.122)


Other ecotoxicity data:

Bacterial respiration inhibition:

EC50 30 min > 100 mg/L (OECD209) (NOTOX Project 230129)


PNEC Derivation:

PNEC = 31.0 μg/L

PNEC (μg/L) = lowest NOEC/10, where 10 is the assessment factor used if chronic toxicity studies from three trophic levels are available. NOEC for fathead minnow body length and dry weight has been used for this calculation since these are the most sensitive endpoints within the three available studies.




Environmental risk classification (PEC/PNEC ratio)

PEC/PNEC = 0.00002139 μg/L / 31.0 μg/L = 0.00000069, i.e. PEC/PNEC ≤ 0.1 which justifies the phrase "Use of zoledronic acid has been considered to result in insignificant environmental risk."


Degradation

Biotic degradation

Ready degradability:

1 % degradation in 28 days (92/69/EC (L383) C.4-C * Carbon dioxide (CO2) evolution). (NOTOX Project 230131)

Simulation studies:

DT50 (water) = 2.8 – 4.0 days

DT50 (total system) is almost equal to DT50 (water) as the radioactivity dissipated nearly completely irreversible to the sediment (= bound residues) (OECD 308). (Springborn Smithers Study 1096.006.750)

During pretests the extraction method was investigated with the following solvents: acetonitril, water, sodium hydroxide (0.1 M), ammoniua hydroxid 5%, acetone, cyclohexane and ethanol:phophoric acid 5% (50:50). However, no extraction of test item was achieved. Therefore, the sediment was extracted once with water.


Justification of chosen degradation phrase:

Zoledronic acid did not pass the ready degradation test. However, based on the results from the study on transformation in water-sediment systems, following OECD308 ( <15% parent at the end of the study in both systems tested), the phrase ‘Zoledronic acid is degraded in the environment’ is chosen.


Bioaccumulation

Partitioning coefficient:

Log Kow < -2.0 (25°C, experimentally determined, method unknown). (internal data, no report / reference available)

Justification of chosen bioaccumulation phrase:

Since log Kow < 4, zoledronic acid has low potential for bioaccumulation.


Excretion (metabolism)

Zoledronic acid is not metabolised and is excreted unchanged via the kidney. (ACLASTA® Core data sheet)



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

  • (NOTOX Project 230107) Fresh water algal growth inhibition test with zoledronic acid. Final report: 20 October 1998.

  • (NOTOX Project 230118) Acute toxicity study in Daphnia magna with zoledronic acid (static). Final report: 30 October 1998.

  • (Springborn Smithers Study 1096.006.230) Zoledronic acid 1AQ/DS 01: Chronic reproduction test with daphnids (Daphnia magna) under semi-static conditions. Final report: 28 May 2009.

  • (Springborn Smithers Study 1096.006.122) Zoledronic acid 1AQ/DS 01: Early life-stage toxicity test with fathead minnow (Pimephales promelas) under flow-through conditions. Final report: 10 July 2009.

  • (NOTOX Project 230129) Activated sludge respiration inhibition test with zoledronic acid. Final report: 08 April 1998.

  • (NOTOX Project 230131) Determination of ‘ready’ biodegradability: Carbon dioxide (CO2) evolution test (modified Sturm test) with zoledronic acid. Final report: 26 June 1998.

  • Springborn Smithers Study 1096.006.750) [14C] ZOL446 Monohydrate: Aerobic transformation in aquatic sediments systems. Final report: 29 May 2009.

  • ACLASTA® Core data sheet, Version 3.0, 29 November 2016.