Läs upp

Cookies

Den här webbplatsen använder så kallade cookies. Cookies är små textfiler som lagras i din dator och sparar information om olika val som du gjort på en webbsida – t ex språk, version och statistik – för att du inte ska behöva göra dessa val en gång till. Tekniken är etablerad sedan många år tillbaka och används idag på väldigt många webbplatser på Internet.

Du kan när som helst ändra cookieinställningarna för denna webbplats.

FASS logotyp
Receptbelagd

Peka på symbolerna och beteckningarna till vänster för en förklaring.

Kontakt och länkar

Sök apotek med läkemedlet i lager

Sök lagerstatus

Flagyl®

MiljöinformationReceptstatusFörmånsstatus
Sanofi AB

Tablett 200 mg
(vit, bikonvex, ca 10 mm, märkt "FLAGYL 200")

Specifikt medel mot anaeroba bakterier och vid trikomonas-, amöba- och giardiainfestation

Aktiv substans:
ATC-kod: P01AB01
Utbytbarhet: Ej utbytbar
Företaget omfattas av Läkemedelsförsäkringen
  • Vad är miljöinformation?

Miljöpåverkan (Läs mer om miljöpåverkan)

Metronidazol

Miljörisk: Användning av metronidazol har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning: Metronidazol är potentiellt persistent.
Bioackumulering: Metronidazol har låg potential att bioackumuleras.


Läs mer

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 = 0.204 µg/L


Where:

A = 1361.945 kg (total sold amount API in Sweden year 2016, data from QuintilesIMS)

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 (ECHA default) (Ref I)

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


Predicted No Effect Concentration (PNEC)

Ecotoxicological studies

Green algae, Pseudokircheriella subcapitata:

EC10 72 h (growth rate) = 19 900 µg/L

EC50 72 h (growth rate) = 39 100 μg/L

(ISO 8692) (Ref II)


Green algae, Chlorella spp:

EC10 72 h (growth rate) = 2 030 µg/L

EC50 72 h (growth rate) = 12 500 μg/L

(ISO 8692) (Ref II)


Water flea, Daphnia magna:

EC50 48 h (inhibition of motility) = >100 000 μg/L

(ISO 6341) (Ref III)


Water flea, Daphnia magna:

NOEC 21 days (reduction in reproduction) = 250 000 μg/L

(OECD 211) (Ref III)


Zebrafish, Brachydanio rerio:

NOEC 96 h (mortality) = 500 000 μg/L

(DS/ISO 7346-1) (Ref II)


Other ecotoxicity data:

PNEC = 12.5 μg/L


The PNEC (μg/L) = lowest EC50/1000 was calculated using results from the most sensitive acute toxicity endpoint and an assessment factor of 1000 (short term toxicity endpoints available for three trophic levels), to add a safety margin to the toxicity endpoint. The most sensitive species was the green algae, Chlorella spp for which the EC50 was 12 500 μg/L.


Environmental Risk Classification (PEC/PNEC ratio)

PEC/PNEC= 0.204/12.5 = 0.02, i.e. PEC/PNEC ≤ 0.1 which justifies the phrase “Use of metronidazole has been considered to result in insignificant environmental risk”


Biodegradation

Ready degradability

Test results showed 1% degradation in 28 days (OECD 301) (Ref IV)


Justification of chosen degradation phrase:

Metronidazole failed to pass the ready degradation test, justifying the phrase: "Metronidazole is potentially persistent".


Bioaccumulation

Partitioning coefficient:

Log Kow = -0.02 at pH 7 (experimentally derived, method unknown) (Ref V)


Justification of chosen bioaccumulation phrase:

Since log Kow < 4 at pH 7, metronidazole has low potential for bioaccumulation.


Excretion (metabolism)

The substance is excreted as about 70% as parent compound (Ref VI). Approximately 30-60% of an oral or IV dose of metronidazole is metabolized in the liver by hydroxylation, side-chain oxidation, and glucuronide conjugation. The major metabolite, 2-hydroxy metronidazole, has some antibacterial and antiprotozoal activity (Ref VII)


References

  1. ECHA, European Chemicals Agency, 2008, Guidance on information requirements and chemical safety assessment. https://echa.europa.eu/guidance-documents/guidance-on-information-requirements-and-chemical-safety-assessment

  2. Lansky P.F. and Halling-Sørensen B, 1997, The toxic effect of the antibiotic metronidazole on aquatic organisms, Chemosphere, 35, 2553-2561.

  3. Wollenberger L., et al. 2000. Acute and chronic toxicity of veterinary antibiotics to Daphnia magna. Chemosphere, 40, p 723-30.

  4. Alexy R., Kümpel T., Kümmerer K., 2004, Assessment of degradation of 18 antibiotics in the Closed Bottle Test, Chemosphere, 57, p 505-512.

  5. Source ChemIDPlus, available as of Sep 12, 2018, at https://chem.nlm.nih.gov/chemidplus/name/metronidazole

  6. Ings RMJ, Law GL, Parnell EW, 1966, The metabolism of metronidazole (1-2'-hydroxyethyl-2-methyl-5-nitroimidazole), Biochemical Pharmacology, 15, 515-519.

  7. McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 892

Välj läkemedelstext
Hitta direkt i texten
Av