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Novartis

Filmdragerad tablett 4 mg
(gul, oval, 10,1×5,6 mm. Tabletterna är märkta med "GXET3".

Medel för behandling av illamående och kräkningar utlösta av kemoterapi, strålbehandling eller i samband med operation

Aktiv substans:
ATC-kod: A04AA01
Läkemedel från Novartis omfattas av Läkemedelsförsäkringen.
Vad är viktig säkerhetsinformation?
2019-09-27: Viktig säkerhetsinformation
Ondansetron bör inte användas under graviditetens första trimester.
  • Vad är miljöinformation?

Miljöpåverkan (Läs mer om miljöpåverkan)

Ondansetron

Miljörisk: Användning av ondansetron har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning: Ondansetron är potentiellt persistent.
Bioackumulering: Ondansetron 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*A(100-R) = 1.5*10-6 * 14.9754  * 100

PEC = 0.00225 μg/L


Where:

A = 14.9754 kg (1.3321 kg ondansetron + 13.6433 kg ondansetronhydrokloriddihydrat) (total sold amount API in Sweden year 2015, data from IMS Health). Reduction of A may be justified based on metabolism data.

R = 0% removal rate (conservatively, it has been assumed there is no loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation)

P = number of inhabitants in Sweden = 9 *106

V (L/day) = volume of wastewater 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

Green Algae (Selenastrum capricornutum):

IC50 96 h (growth rate inhibition) > 3,100 μg/L (OECD 201) (Reference 8)

NOEC = 620 μg/L


Water flea (Daphnia magna)

Acute toxicity

EC50 48 h (immobility) = 28,000 μg/L (OECD 202) (Reference 5)

NOEC = 14,000 μg/L


Water flea (Ceriodaphnia dubia)

Chronic toxicity

NOEC 7 d (reproduction) = 320 μg/L (USEPA 1002) (Reference 11)


Rainbow Trout (Oncorhyncus mykiss):

Acute toxicity

LC50 96 h (lethality) = 6,500 μg/L (OECD 203) (Reference 9)

NOEL = 2,600 μg/L


Fathead minnow (Pimephales promelas):

Chronic toxicity

No data


Other ecotoxicity data:

Microorganisms in activated sludge:

EC50 3 h (inhibition) > 1,000,000 μg/L @ 3 hrs (OECD 209) (Reference 4)

NOEC = 100,000 μg/L


PNEC = 320/100 = 3.20 μg/L


PNEC (μg/L) = lowest NOEC/100, where 100 is the assessment factor applied for two long-term NOECs when such results have not been generated from that showing the lowest L(E)C50 of the short-term tests. The lowest NOEC for water flea (= 320 µg/L) has been used for this calculation since it is the most sensitive of the two tested species.


Environmental risk classification (PEC/PNEC ratio)

PEC/PNEC = 0.00225 μg/L / 3.20 μg/L = 0.0007, i.e. PEC/PNEC ≤ 0.1 which justifies the phrase “Use of Ondansetron has been considered to result in insignificant environmental risk.”




Degradation

Biotic degradation

Ready degradability:

No data

Inherent degradability:

19% degradation in 28 days (OECD 302). (Reference 10)

Soil Metabolism:

20-99.9% degradation in 64 days (TAD 3.12) (Reference 7)


Abiotic degradation

Hydrolysis:

50% degradation (pH 7) > 1 year (TAD 3.09) (Reference 3)

Photolysis:

No data

Justification of chosen degradation phrase:

Ondansetron is not readily degradable nor inherently biodegradable. The phrase “Ondansetron is potentially persistent” is thus chosen.


Bioaccumulation

Partitioning coefficient:

Log Dow = 1.00 (TAD 3.02) (Reference 6)

Log Dow at pH 5 = 0.23

Log Dow at pH 7 = 1.00

Log Dow at pH 9 = 1.26


Justification of chosen bioaccumulation phrase:

Since log Dow < 4 at pH 7, the substance has low potential for bioaccumulation.


Excretion (metabolism)

Ondansetron is cleared from the systemic circulation predominantly by hepatic metabolism. Less than 5% of the absorbed dose is excreted unchanged in the urine. (Reference 2).


PBT/vPvB assessment

Ondansetron does not fulfil the criteria for PBT and/or vBvP.

All three properties, i.e. ‘P’, ‘B’ and ‘T’ are required in order to classify a compound as PBT (Reference 1). Ondansetron does not fulfil the criteria for PBT and/or vBvP based on log Dow < 4.


References

1. ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment.


2. Global Datasheet Ondansetron. Version 39. 01 May 2015.


3. Mao J. Ondansetron hydrochloride – Determination of Aqueous Hydrolysis Rate Constant and Half-Life.. Report No. 91-8-3891. Springborn Laboratories, inc. November 1991


4. Hartley DA. Ondansetron hydrochloride – Activated Sludge Respiration Inhibition. Report No. 91-8-3870. Springborn Laboratories, inc. November 1991.


5. LeLievre MK. Ondansetron hydrochloride – Acute Toxicity to Daphnids (Daphnia pulex) under Static Conditions. Report No. 91-8-3882. Springborn Laboratories, inc, November 1991.


6. Colwyn TC. GR38032X: Determination of Physico-Chemical Properties. Report No. 94/GLX171/1157. Pharmaco LSR Ltd, February 1995.


7. Morgan P. GR38032X: Biodegradation in Soil. Report No. 94/GLX172/0783. Pharmaco LSR Ltd, February 1995.


8. Desjardins D, Kendall T, Krueger HR. Ondansetron hydrochloride: A 96-hour Toxicity Test with the Freshwater Alga (Selenastratum capricornutum). Report No. 374A-121. Wildlife International Limited, July 2004.


9. Palmer SJ, Kendall TZ, Krueger HR. Ondansetron hydrochloride: A 96-hour Static Acute Toxicity Test with the Rainbow Trout (Oncoryhynchus mykiss). Report No. 374A-120. Wildlife International Limited, July 2004.


10. Shaefer EC. Ondansetron hydrochloride: An Evaluation of Inherent Biodegradability Using the Zahn-Wellens Test. Report No. 374E-122A. Wildlife International Limited, March 2005.


11. Goodband TJ: Ondansetron hydrochloride: Daphnid, Ceriodaphnia Dubia Survival and Reproduction Test. Report No. 1127/01213. Safepharm Laboratories Limited, July 2007.