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Fucidin®

MiljöinformationReceptstatusFörmånsstatus
LEO Pharma

Filmdragerad tablett 250 mg
(Gråvit, marmorerad oval bikonvex filmdragerad tablett utan tryck.)

Stafylokockantibiotikum

ATC-kod: J01XC01
Läkemedel från LEO Pharma omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöpåverkan (Läs mer om miljöpåverkan)

Fusidinsyra (vattenfri)

Miljörisk: Användning av fusidinsyra har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning: Fusidinsyra bryts ned långsamt i miljön.
Bioackumulering: Fusidinsyra har låg potential att bioackumuleras.


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Detaljerad miljöinformation

Environmental risk:

The total sale of active ingredient in Fucidin® in Sweden in 2014 was (obtained from 2014 IMS Health):

7.9708 Kg fusidic acid hemihydrate

12.7998 Kg fusidic acid water free

70.9649 Kg sodium fusidate

Total 91.74 Kg


PEC (µg/L) = A×1000000000×(100-R)/(365×P×V×D×100)= 1.5×10-6×A×(100-R)


Where:


A (Kg/year) = total actual API sales (active moiety) in Sweden for the most recent year.

R (%) = removal rate (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 [1])

D = factor for dilution of waste water by surface water flow = 10 (ECHA default [1])


The factor 1000000000 in the equation converts the quantity from Kg to µg


The factor of 365 in the denominator converts from annual to daily quantity used. Simplifying all the default values into a single factor gives the second equation.


PEC = 1.5 x 10-6 x 91.74 x (100-0) = 0.014 µg/L


Ecotoxicological studies:

The active ingredient in Fucidin® is fusidic acid or its salt sodium fusidate. In water with a neutral pH fusidic acid will be dissociated as sodium fusidate.

The acute toxicity of sodium fusidate has been tested towards an algae, crustacean and fish. All toxicity tests were performed in accordance with OECD test guidelines.


Acute toxicity:

Algae (Pseudokirchneriella subcapitate) growth inhibition test:

EC50, 72h (endpoint) = 4300 µg/L (Corresponding 95% confidence limits 4100-4500 µg/L) (OECD Test guideline No. 201) (Study report, DHI Water and Environment, 2006 [2])

Crustacean (Daphnia magna Straus (Cladocera, Crustacea)) Immobilization test:

EC50, 48h (endpoint) = 367000 µg/L (Corresponding 95% confidence limits 294000-443000 µg/L) (OECD Test guideline No. 202) (Study report, DHI Water and Environment, 2006 [3])

Zebra fish (Danio rerio) acute toxicity test:

LC50, 96h (endpoint)> 400000 µg/L (OECD Test guideline No. 203) (Study report, DHI Water and Environment, 2006 [4])


LC50, 96h > 400000 µg/L


PNEC is calculated by dividing the lowest EC50/LC50 value by a safety factor. An assessment factor of 1000 is normally applied as acute short-term toxicity data is available (ECHA [1]).


PNEC = 4300 µg/L/1000 = 4.3 µg/L




PEC/PNEC = 0.014 / 4.3 = 0.003


PEC/PNEC < 0.1 which means that the phrase “Use of Fusidic acid has been considered to result in insignificant environmental risk” is used.


Degradation:

Sodium fusidate is not readily biodegradable, as only 54% was found degraded after 20 days according to the OECD 301B ready biodegradability test guideline (VKI, Vandkvalitetsinstituttet, 1995 [5]). The criterion of readily biodegradability is 60%.


Failure to pass the ready biodegradability test may lead to a more detailed test set-up, simulating the STP conditions, i.e. not directly comparable to a sewage treatment plant (STP), but with a much more realistic set-up.


Compared with the ready biodegradability test (OECD 301B), the inoculum is much higher and the retention time is longer in the modified semicontinous activated sludge (SCAS) test (OECD 302A), as is expected in a STP. Thus the degrading microbial community has the possibility to adapt to the test compound. The concentration of test compound, i.e. sodium fusidate is much less, likewise as expected in a STP. If only >20% is degraded (i.e. loss of DOC) in the SCAS-test, the test compound may be regarded as inherently biodegradable, whereas if >70% is degraded (i.e. loss of DOC), it is an evidence of ultimate biodegradability.


Sodium fusidate was thus tested in the modified SCAS-test (OECD 302A) using sludge from the Danish STP I/S Avedøre Kloakværk (VKI, Vandkvalitetsinstituttet, 1995 [6]). After 4 days of equilibration of the sludge reactors sodium fusidate was daily added to a nominal concentration of 10 mg/L. From day 4 to 18 samples were taken in the interval from 5 min to 23 h after addition of sodium fusidate and from day 18 to 32 samples were taken 5 min and 3 h after and analysed by means of high-performance liquid chromatography with a detection limit (DL) of 0.5 mg/L, see the figure below. After 23 h the concentration of sodium fusidate was below DL.

Removal rate of sodium fusidate

As seen from the figure the removal rate after 23 h is >94% and after 3h it is approximately 45%.


Based on the log KOW of 2.7, a KD of 0.05 L/g SS (calculated from added sodium fusidate and the concentration after 5 min and the sludge concentration) and a Henry’s law constant of 3×10-6 atm×m3/mol it is assessed that the sorption and evaporation removal processes are negligible, suggesting biodegradation to be the main route of removal.


The following phrase applies: “Fusidic acid is slowly degraded in the environment”.


Bioaccumulation:

LogKow, sodium fusidate = 2.6 at pH 7.4 (LEO Pharma A/S [7]). Test method unknown.

As LogKow < 4 the following phrase applies: “Fusidic acid has low potential for bioaccumulation”.


References:

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

  2. DHI Water and Environment, GLP study No. 91331/603: Algal growth inhibition test with Sodium Fusidste NOS, 2006

  3. DHI Water and Environment, GLP study No. 91319/603: Daphina magna Immobilization test with Sodium Fusidate NOS, 2006

  4. DHI Water and Environment, GLP study No. 91335/603: Zebra fish (Danio rerio) acute toxicity test with Sodium Fusidate NOS, 2006

  5. VKI, Vandkvalitetsinstituttet: Bionedbrydelighed af Na-Fusidin – CO2 respirationstest, 1995

  6. VKI, Vandkvalitetsinstituttet: Fusidins aerobe bionedbrydelighed under forhold der simulerer et aktivt slamanlæg, 1995

  7. Experimental value, Analytisk-Kemisk Forsøgslaboratorium LEO Pharma A/S, April 1992