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Lescol®

MiljöinformationReceptstatusFörmånsstatus
Novartis

Kapsel, hård 20 mg
(Tillhandahålls för närvarande ej) (mörkt rödbrun, ogenomskinlig överdel och en blekgul, ogenomskinlig underdel med rött tryck "XU 20 mg")

HMG-CoA-reduktashämmare

Aktiv substans:
ATC-kod: C10AA04
Utbytbarhet: Ej utbytbar
Läkemedel från Novartis omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöpåverkan (Läs mer om miljöpåverkan)

Fluvastatin

Miljörisk: Användning av fluvastatin har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning: Fluvastatin är potentiellt persistent.
Bioackumulering: Det kan inte uteslutas att fluvastatin kan bioackumuleras, då data saknas.


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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 * 2.2341 * 100

PEC = 0.000335 μg/L = 0.335 ng/L

Where:

A = 2.2341 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

Cyanobacteria / blue green algae (Nostoc) (Doc. No. 4.08; USFDA, 1987) (internal data, ABC Study No. 40021):

NOEC > 40 mg/L


Crustacean (Daphnia magna):

Acute toxicity

EC50 48 h (immobilisation) = 47.0 mg/L (USFDA Doc. No. 4.08, 1987) (internal data, ABC Study No. 39750)


Fish (Lepomis macrochirus, bluegill sunfish):

Acute toxicity

LC50 96 h (endpoint) = 19 mg/L (USFDA Doc. No. 4.11, 1987) (internal data, ABC Study No. 39751)


Other ecotoxicity data:

Microbial growth inhibition

Minimum inhibitory concentration = 13.3 mg/L (USFDA Doc. No. 4.08, 1987) (internal data, ABC Study No. 40021)


PNEC = 19.0 μg/L

PNEC (μg/L) = lowest EC50/1000, where 1000 is the assessment factor used if acute toxicity data from three trophic levels is available. LC50 for bluegill sunfish has been used for this calculation since it is the most sensitive of the three tested species.


Environmental risk classification (PEC/PNEC ratio)

PEC/PNEC = 0.000335 μg/L / 19.0 μg/L = 0.0000176, i.e. PEC/PNEC ≤ 0.1 which justifies the phrase "Use of fluvastatin has been considered to result in insignificant environmental risk."


Degradation 

Biotic degradation

14 % (69 days) not degradable in biological waste water treatment plant (Method USEPA, 1987). (internal data, no reference available)


Abiotic degradation

Photolysis:

Rapid decomposition of fluvastatin solutions in sunlight. t1/2 < 2 min (exposure to natural sunlight, under laboratory conditions) (internal data, no reference available)

Justification of chosen degradation phrase:

As Fluvastatin has not been found to be degradable in biological waste water treatment plants and the abiotic degradation data does not fulfill the requirements for determining degradation potential, the phrase 'Fluvastatin is potentially persistent' is chosen


Bioaccumulation

Partitioning coefficient:

Log Kow = 4.85 (method unknown) (Clarke’s 2007)

pKa = 4.6 (method unknown) (Clarke’s 2007)

Log Dow = 2.5 at pH 7 (calculated according to principles described in Cunningham, 2004).

Justification of chosen bioaccumulation phrase:

Since no reliable, measured data is available the phrase ‘The potential for bioaccumulation of fluvastatin cannot be excluded due to lack of data’ is chosen.


Excretion (metabolism)

Fluvastatin is excreted to about 6% in the urine and 93% in the feces, and less than 2% is excreted as parent compound. (LESCOL® 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


- ABC Study No. 40021


- ABC Study No. 39750


- ABC Study No. 39751


- Clarke's Analysis of Drugs and Poisons, accessed March 30, 2007 http://www.medicinescomplete.com/mc/clarke/current/CLK0762.htm


- V.L. Cunningham (2004) Special characteristics of phamaceuticals related to environmental fate. In: Pharmaceuticals in the environment. Sources, Fate, Effects and Risks. 2nd edition. Ed. Klaus Kümmerer, Springer-Verlag Berlin Heidelberg.


- LESCOL® Core Data Sheet, Version 2.1, 14 March 2016.