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Rifadin®

MiljöinformationReceptstatusFörmånsstatus
Sanofi AB

Oral suspension 20 mg/ml
(röd, med hallonsmak)

Medel mot mykobakterier, medel mot tuberkulos, antibiotika

Aktiv substans:
ATC-kod: J04AB02
Utbytbarhet: Ej utbytbar
Läkemedel från Sanofi AB omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöpåverkan (Läs mer om miljöpåverkan)

Rifampicin

Miljörisk: Risk för miljöpåverkan av rifampicin kan inte uteslutas då det inte finns tillräckliga ekotoxikologiska data.
Nedbrytning: Det kan inte uteslutas att rifampicin är persistent, då data saknas.
Bioackumulering: Rifampicin har hög 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 = 0.044 µg/L


Where:

A = 293,40 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)


Predicted No Effect Concentration (PNEC)

Ecotoxicological studies

Acute toxicity:

Water flea, Daphnia magna:

EC50 48 h (immobility): 3 300 000 μg/L

Protocol: Specific: IRSA CNR

Internal report (Ref II)


Other ecotoxicity data:

PNEC (acute toxicity) = 3 300 000/1000 = 3 300 μg/L.


The PNEC (μg/L) was calculated using results from only available toxicity endpoint (Daphnia magna acute toxicity, EC50 = 3 300 000 μg/L) and an assessment factor of 1000, to add a safety margin to the toxicity endpoint.



Environmental Risk Classification (PEC/PNEC ratio)

PEC/PNEC = 0.044/3 300 = 1,33*10-5


Since the PNEC was calculated with available results for one trophic level only, the data are considered insufficient for adequately assessing the impact on the environment, hence justifies the phrase "risk of environmental impact of rifampicin cannot be excluded, since there is not sufficient ecotoxicity data available".


Degradation

No data available. "The potential for persistence of rifampicin cannot be exceluded, due to lack of data."


Bioaccumulation

Rifampicin has high potential for bioaccumulation based on a calculated Log Kow = 4.24.

(Method: US EPA; Estimation Program Interface (EPI) Suite. Ver.3.11. June 10, 2003.)

(Ref III)


Excretion

After absorption, rifampin is rapidly eliminated in the bile, and an enterohepatic circulation ensues. During this process, rifampin undergoes progressive deacetylation so that nearly all the drug in the bile is in this form in about 6 hours. This metabolite has antibacterial activity. Intestinal reabsorption is reduced by deacetylation, and elimination is facilitated. Up to 30 % of a dose is excreted in the urine, with about half as unchanged drug. (Ref IV)


References

  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. Internal report, Lepetit S.p.A. Stabilimento di Brindisi: Ecotossicita di alcuni prodotti puri: Test Dafnia, valutazione di IC50a 24 e 48 ore. Report # 98-007, March 1998. OECD protocols in combination with an Italian protocol developed by the IRSA CNR (Institute of Water Research and the National Board of Research).

  3. US EPA; Estimation Program Interface (EPI) Suite. Ver.3.11. June 10, 2003. Available from, as of April 8, 2004: http://www.epa.gov/oppt/exposure/pubs/episuitedl.htm

  4. Rifater® package insert, Sanofi-Aventis U.S., April 2013.