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Sanofi AB

Filmdragerad tablett 250 mg
(avlång med skåra, gulvit till rödvit, storlek 6,1 mm x 13,2 mm)


ATC-kod: J01MA12
Läkemedel från Sanofi AB omfattas av Läkemedelsförsäkringen.
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2020-10-29: Viktig säkerhetsinformation
Systemiska och inhalerade fluorokinoloner: risk för hjärtklaffsinsufficiens
  • Vad är miljöinformation?



Levofloxacin (vattenfri)

Miljörisk: Användning av levofloxacin har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning: Det kan inte uteslutas att levofloxacin är persistent, då data saknas.
Bioackumulering: Levofloxacin 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)

PEC = 0.0071 µg/L


A = 47.012 kg (total sold amount API in Sweden year 2017, data from IQVIA)

R = 0 % removal rate (due to 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 (Ref I)

D = factor of dilution of waste water by surface water flow = 10 (Ref I)

According to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/4447/00), use of levofloxacin is unlikely to represent a risk for the environment, because the predicted environmental concentration (PEC) is below the action limit of 0.01 μg/L.

Predicted No Effect Concentration (PNEC)

Ecotoxicological studies

Green algae, Pseudokircheriella subcapitata:

Acute toxicity:

EC50 72 h (growth inhibition): 7 400 μg/L

Protocol: FDA 4.01

(Ref II)

Water flea, Daphnia magna :

Acute toxicity:

NOEC 48 h (survival): > 10 000 μg/L

EC50 (not determined) < 10 % mortality up to 10 mg/L.

Protocol: US EPA (Ref III)

(Ref II)

Fathead minnow, Pimephales promelas:

Acute toxicity:

NOEC 7 d (larval survival and growth): > 10 000 μg/L

EC50 (not determined) < 8% mortality up to 10 mg/L.

Protocol: US EPA (Ref IV)

(Ref II)


Acute toxicity:

Adverse effect on activated sludge microorganisms (growth inhibition)

IC50 20 h: 1 000 μg/L

Protocol: OECD 209

(Ref V)

Other ecotoxicity data:

PNEC = 7.4 ug/L

PNEC (μg/L) = lowest EC50 7 400/1 000, where 1 000 is the assessment factor used (acute toxicity data only). EC50 for green algae, Pseudokircheriella subcapitata 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= 0.0071/7.4 = 0.00096

PEC/PNEC ≤ 0.1 which justifies the phrase “use of levofloxacin has been considered to result in insignificant environmental risk".


Biotic degradation

No data available, which justifies for the degradation pharse: "the potential for persistence of levofloxacin cannot be excluded, due to lack of data".

Abiotic degradation

The substance is light sensitive. The photo-degradation half-life is estimated at 4-5 days (Ref VI).


The substance has low bioaccumulation potential, as indicated by a calculated log Kow value of - 0.39. (Hansch and Leo method; Ref VII)


Levofloxacin is mainly eliminated through urinary excretion (more than 85 % of the administered dose). The substance is eliminated slightly metabolized. The main metabolites, desmethylevofloxacin and the N-oxide, account for less than 5 % of the dose excreted and are pharmacologically inactive. (Ref VIII)


  1. ECHA, European Chemicals Agency, 2008 Guidance on information requirements and chemical safety assessment. http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm

  2. Robinson AA, Belden JB, Lydy MJ: Toxicity of fluoroquinolone antibiotics to aquatic organisms. Environmental Toxicology and Chemistry, 2005, 24,423-430.

  3. U.S. Environmental Protection Agency. 1988. Protocols for short term toxicity screening of hazardous waste sites. EPA 600/3-88/029. Corvallis, OR.

  4. U.S. Environmental Protection Agency. 1994. Short-term methods for estimating the chronic toxicity of effluents and receiving waters to freshwater organisms, 3rd ed. EPA/600/4-91/002. Office of Research and Development, Cincinnati, OH.

  5. Kümmerer K., Alexy R., Hüttig J. and Schöll A.: Standardized tests fail to assess the effects of antibiotics on environmental bacteria, Water Research, 2004, 38, 2111-2116.

  6. Lam MW, Cora JY, Brain RA, Johnson DJ, Hanson MA, Wilson CJ, Richards SM, Solomon KR, Mabury SA: Aquatic persistence of eight pharmaceuticals in a microcosm study. Environmental Toxicology and Chemistry, 2004, 23, 1431-1440.

  7. Hansch, C., Leo, A., D. Hoekman. Exploring QSAR - Hydrophobic, Electronic, and Steric Constants. Washington, DC: American Chemical Society., 1995, p. 156.

  8. Vidal, 2013, Vidal Product Monograph – Tavanic® 500 mg.