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Triatec®

MiljöinformationReceptstatusFörmånsstatus
Sanofi AB

Tablett 2,5 mg
(gulskiftande till gul, avlång med brytskåra, övre stämpel 2,5 och företagslogo, lägre stämpel HMR och 2,5.)

ACE-hämmare

Aktiv substans:
ATC-kod: C09AA05
Läkemedel från Sanofi AB omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöpåverkan (Läs mer om miljöpåverkan)

Ramipril

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


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Detaljerad miljöinformation

*Ramipril is a prodrug. Since all data referenced is for the prodrug ramipril, this risk assessment is for the prodrug and not the active metabolite, ramiprilat.


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 = 0.038 µg/L


Where:

A = 255.1285 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)

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

Green algae, Desmodesmus subspicatus:

EC50 72 h (biomass) > 100 000 μg/l

EC50 72 h (growth inhibition): >100 000 μg/l

(Protocol: OECD 201)

(Ref II)


Water flea, Daphnia magna:

EC50 48 h (acute immobilization) > 100 000 μg/l

(Protocol: OECD 202 )

(Ref III)


Zebrafish, Brachydanio rerio:

LC50 96 h (mortality) > 100 000 μg/l

(Protocol: OECD 203)

(Ref IV)


Other ecotoxicity data:

PNEC = 100 000/1000 = 100 μg/l.


The PNEC (μg/L) was calculated using results from the most sensitive acute toxicity endpoint and an assessment factor of 1000 (at least one short-term L(E)C50 from each of three trophic levels). Green algae, daphnia and fish were equally sensitive, all with an E(L)C50 above 100 000 μg/l .


Environmental Risk Classification (PEC/PNEC ratio)

PEC/PNEC = 0.038/100 = 0.00038

PEC/PNEC ≤ 0.1 which justifies the phrase: “Use of ramipril has been considered to result in insignificant environmental risk.”


Degradation

Biotic degradation

Ready biodegradability:

Test results showed 20 to 50 % degradation in 28 days.

(Protocol: OECD 301A; method of analysis DOC decrease)

(Ref V)


Justification of chosen degradation phrase:

Ramipril failed to pass the ready degradation test according to OECD criteria, hence "Ramipril is potentially persistent"


Bioaccumulation

The substance has a low potential to bioaccumulation, as indicated by a calculated log Kow of 3.77 (Hansch Leo method) (Ref VI).


Excretion

After oral administration, cleavage (primarily in the liver) of the ester group converts ramipril to its active di-acid metabolite, ramiprilat. Other metabolites identified are the diketopiperazine ester, the diketopiperazine acid, and the glucuronides of ramipril and ramiprilat, all of which are inactive. About 60% of the parent drug and its metabolites are eliminated in the urine, and about 40% is found in the feces. The absolute bioavailabilities of ramipril and ramiprilat were 28% and 44%, respectively, when 5 mg of oral ramipril was compared with the same dose of ramipril given intravenously. Less than 2% of the administered dose is recovered in urine as unchanged ramipril. (Ref VI)


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. Internal report, Aventis Pharma Deutschland: Growth Inhibition Test with Fresh Water Algae (Desmodesmus subspicatis). OECD 201. Report # PT02-0045, July 2002.

  3. Internal report, Aventis Pharma Deutschland Acute Toxicity Study on Daphnia. OECD 202. Report # PT02-0044, June 2002.

  4. Internal report, Hoechst: Acute Toxicity Study on Zebra Fish. OECD 203. Report # 94.0289, July 1994.

  5. Internal report, Hoechst: Study of Biodegradability of Ramipril, OECD 301B. Report # 94-0057-41, October 1994.

  6. Ramipril Safety Data Sheet: Sanofi-Aventis Deutschland GmbH, February 2012.