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Targocid®

Miljöinformation
Receptstatus
Förmånsstatus
Sanofi AB

Pulver till injektions-/infusionsvätska, lösning 200 mg
(Tillhandahålls ej) (Porös, benvit, homogen massa. Klar, gulaktig till mörkt gul lösning.)

Antibakteriella glykopeptider

Aktiv substans:
ATC-kod: J01XA02
Utbytbarhet: Utbytbara läkemedel
Läkemedel från Sanofi AB omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöinformation

Miljöpåverkan

Teikoplanin

Miljörisk: Användning av teikoplanin har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning: Teikoplanin är potentiellt persistent.
Bioackumulering: Teikoplanin 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) = 1.37*10-6*A*(100-R)


PEC = 9.39 * 10-5 µg/L


Where:

A = 0.68544 kg (total sold amount API in Sweden year 2020, 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 = 10*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


Algae (Anabaena flos-aquae):

EC50 72 h (growth rate): 236 µg/L

EC10 72 h (growth rate): 12.9 µg/L
Protocol: OECD 201

(Ref II)


Crustacean (Daphnia magna):

EC50 48 h (immobilization): > 100 000 µg/L
Protocol: OECD 202
(Ref III)


Fish (Danio Rerio):

LC50 96 h (lethality): > 100 000 µg/L
Protocol: OECD 236
(Ref IV)


Other ecotoxicity data:


Lowest EC50/1000:


Algae (Anabaena flos-aquae):

EC50 72 h (growth rate): 236 µg/L


PNEC : 236 µg/L/1000 = 0.236 µg/L


Environmental Risk Classification (PEC/PNEC ratio)


PEC/PNEC: 0.00040


1 < PEC/PNEC ≤ 0.1: Use of teicoplanin has been considered to result in insignificant environmental risk.


Degradation

Test showed 0% degradation in 28 days. Therefore, teicoplanin is considered to be potentially persistent.

(Ref V)


Bioaccumulation

Partitioning coefficient:

Teicoplanin has low potential for bioaccumulation, as indicated by a calculated log Kow of 0.8 (method/model: XLogP3-AA)
(Ref VI)


Excretion (metabolism)

In 16 days, more than 80% of administered teicoplanin are excreted in urine as parent compound (Ref VII). Two metabolites (metabolites 1 and 2; 2 to 3% of total teicoplanin) have been isolated and their structures were found to be new teicoplanin-like molecules, bearing 8-hydroxydecanoic and 9-hydroxydecanoic acyl moieties, respectively.
(Ref VIII)


References

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

  2. Sanofi Internal report: Teicoplanin: Toxicity to Anabaena flos-aquae in an Algal Growth Inhibition Test, Study No 127621218, April 2018

  3. Sanofi internal report: : Teicoplanin : Acute toxicity to Daphnia magna in a static 48-hour Immobilisation Test, Study No 127621220, March 2018

  4. Sanofi internal report: Teicoplanin : Acute toxicity to Zebrafish (Danio rerio) Embryos in a 96-hour Static Test, Study No 127621238, March 2018

  5. Sanofi internal report: Teicoplanin Sodium Salt: ready biodegradability in a manometric respirometry test, Study No 135541163, October 2018

  6. Pubchem, Targocid, 61036-62-2, NCBI. Available: http://pubchem.ncbi.nlm.nih.gov/summary/summary.cgi?cid=16131925, Accessed Feb 01, 2017

  7. Vidal, 2013, Vidal Product monography – Targocid 100 mg lyoph sol

  8. DrugBank http://www.drugbank.ca/drugs/DB06149

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