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Chirocaine

AbbVie

Infusionsvätska, lösning 0,625 mg/ml
(Klar lösning)

Långverkande lokalanestetikum och -analgetikum

Aktiv substans:
ATC-kod: N01BB10
Utbytbarhet: Ej utbytbar
Läkemedel från AbbVie omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöinformation

Miljöpåverkan (Läs mer om miljöpåverkan)

Levobupivakain

Miljörisk: Risk för miljöpåverkan av levobupivakain kan inte uteslutas då det inte finns tillräckliga ekotoxikologiska data.
Nedbrytning: Det kan inte uteslutas att levobupivakain är persistent, då data saknas.
Bioackumulering: Levobupivakain 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)

PEC (μg/L) = (5.4*109*(100-0))/(365*9*106*200*10*100)

PEC = 0.00082 μg/L


Where:

A = 5.4 kg (total sold amount API in Sweden year 2018, data from IQVIA) (Ref. 1)

R = 0% removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation) = 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) (Ref. 2)

D = factor for dilution of wastewater by surface water flow = 10 (ECHA default) (Ref. 2)

(Note: the factor 109 converts the quantity Distressed from kg to mcg).


A = 5.4 kg

R = 0%

PEC = 0.00082 μg/L


Predicted No Effect Concentration (PNEC)

PNEC = Not determined


Ecotoxicological studies*


Acute toxicity for the crustacean, Daphnia magna, has been determined for structurally similar bupivacaine, but no ecotoxicological studies were found for Levobupivacaine.


Environmental risk classification (PEC/PNEC ratio)

Risk of environmental impact of Levobupivacaine cannot be excluded, since no ecotoxicity data are available.


Degradation*

The potential for persistence of Levobupivacaine cannot be excluded, due to lack of data.


Bioaccumulation


Partitioning coefficient:

Experimental data from the literature:


pKa (Dissociation Constant) = 8.1 (Ref. 3)

Log P (Octanol Water Coefficient) = 3.6 (Ref. 3)

Bioaccumulation Estimates from Log Kow: BCF = 84.28 (Ref. 4)


Justification of chosen bioaccumulation phrase:

Since BCF < 500 and log P < 4 at pH 7, the substance has low potential for bioaccumulation.


Excretion (metabolism)


Levobupivacaine is extensively metabolized with no unchanged levobupivacaine detected in urine or feces. In vitro studies using [14C] levobupivacaine showed that CYP3A4 isoform and CYP1A2 isoform mediate the metabolism of levobupivacaine to desbutyl levobupivacaine and 3-hydroxy levobupivacaine, respectively. In vivo, the 3-hydroxy levobupivacaine appears to undergo further transformation to glucuronide and sulfate conjugates. Following intravenous administration, recovery of the radiolabeled dose of levobupivacaine was essentially quantitative with a mean total of about 95% being recovered in urine and feces in 48 hours. Of this 95%, about 71% was in urine while 24% was in feces. (Ref. 5, 6)


References

  1. IQVIA. 2018. IQVIA / LIF - kg consumption/2018.

  2. Committee for Medicinal Products for Human Use (European Medicines Agency). Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use (EMEA/CHMP/SWP/4447/00), 01 June 2006.

  3. PubChem. 2019. Levobupivacaine Compound Summary: Experimental Properties. Available URL: https://pubchem.ncbi.nlm.nih.gov/. Accessed 22 October 2019.

  4. ChemSpider. 2020. Levobupivacaine. Available URL: http://www.chemspider.com/Chemical-Structure.83289.html?rid=b5f842b1-69e8-425e-beb6-eb29a891fdbaAccessed 10 January 2020.

  5. Darwin Discovery Limited. 1999. Chirocaine® (Levobupivacaine Injection) Final Draft Package Insert in US FDA Center for Drug Evaluation and Research Application Number: NDA Final Printing Label. Available URL: https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20997_CHIROCAINE_prntlbl.pdf. Accessed 23 October 2019.

  6. AbbVie Ltd. Chirocaine 7.5mg/ml solution for injection/concentrate for solution for infusion: Summary of Product Characteristics; Updated 21-Jun-2019. Available URL: https://www.medicines.org.uk/emc/product/6636/smpc. Accessed 23 October 2019.