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Methergin®

MiljöinformationReceptstatusFörmånsstatus
Novartis

Tablett 0,125 mg
Avregistreringsdatum: 2018-12-31 (Tillhandahålls ej) (ca 6 mm, bruna)

Selektivt uteruskontraherande sekalepreparat

Aktiv substans:
ATC-kod: G02AB01
För information om det avregistrerade läkemedlet omfattas av Läkemedelsförsäkringen, kontakta Läkemedelsförsäkringen.
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Miljöpåverkan (Läs mer om miljöpåverkan)

Metylergometrin

Miljörisk: Användning av metylergometrin har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning: Metylergometrin är potentiellt persistent.
Bioackumulering: Metylergometrin 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 = 0.000001365 μg/L = 0.001365 ng/L

Where:

A = 0.0091 kg (total sold amount API in Sweden year 2015, data from IMS Health).

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) (ECHA 2008)

D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (ECHA 2008)


Predicted No Effect Concentration (PNEC)

Ecotoxicological studies

Algae (Pseudokirchneriella subcapitata) (OECD 201) (Ibacon Project 106291210):

EC50 72 h (growth rate) > 76 mg/L (highest concentration tested due to the limit of water solubility of the test item)

EC10 72 h (growth rate) = 34.5 mg/L

NOEC 72 h (growth rate) = 15.0 mg/L


Crustacean (Waterflea, Daphnia magna):

Acute toxicity

EC50 48 h (immobilisation) = 39.1 mg/L, (OECD 202) (Ibacon Project 106291220)




Fish (Rainbow trout, Oncorhynchus mykiss):

Acute toxicity

LC50 96 h (lethality) > 100.0 mg/L (OECD 203) (Ecotoxicology Ciba Study No. 938291)


Other ecotoxicity data:

Bacterial respiration inhibition (activated sludge microorganisms)

EC50 3 h > 100.0 mg/L (OECD 209), (Ecotoxicology Ciba Study No. 938288)

PNEC = 39.1 mg/L / 1000 = 39.1 µg/L

PNEC (μg/L) = lowest EC50/1000, where 1000 is the assessment factor used, if acute toxicity values for 3 trophic levels are available. EC50 from Daphnia magna immobilization (OECD 202) 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 = 0.000001365 μg/L / 39.1 µg/L = 3.49 x 10 -8, i.e. PEC/PNEC ≤ 0.1 which justifies the phrase "Use of methylergometrine has been considered to result in insignificant environmental risk."


Degradation 

Biotic degradation

Ready degradability:

9.0 % degradation in 28 days, not readily biodegradable (OECD 301B). (Ecotoxicology Ciba Study No. 938287)

Justification of chosen degradation phrase:

Methylergometrine is not readily biodegradable and shows only a very low level of mineralization. It can be therefore be classified as ‘Methylergometrine is potentially persistent’.


Bioaccumulation

Partitioning coefficient:

Log Kow = 1.01 (method unknown) (Novartis internal value. No report / reference available).

Justification of chosen bioaccumulation phrase:

Since logKow < 4, the phrase ‘Methylergometrine has low potential for bioaccumulation’ is chosen.


Excretion (metabolism)

A study in male volunteers has shown that only about 3% of an oral dose is eliminated as parent drug in the urine. The drug is mainly eliminated with the bile into the feces. (Novartis Core Data Sheet, 2011)


References


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

  • Ibacon Project 106291210. Methylergometrine hydrogene maleate: Toxicity to Pseudokirchneriella subcapitata in an algal growth inhibition test. Final report: May 18, 2016.

  • Ibacon Project 106291220. Methylergometrine hydrogene maleate: Acute toxicity to Daphnia magna in a static 48-hour immobilisation test. Final report: March 17, 2016.

  • Ecotoxicology Ciba Study No. 938291. Report not available anymore.

  • Ecotoxicology Ciba Study No. 938288. Report not available anymore.

  • Ecotoxicology Ciba Study No. 938287. Report not available anymore.

  • Novartis Core Data Sheet for Methergin. Version 1.0. 06 October 2011


Strukturformel

CAS-Nr. 57432-61-8


Phys.-chem. Properties:

Water Solubility: 40.0 g/L (20°C)