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Lisinopril 2care4

(Parallellimporterat)
2care4 ApS

Tablett 20 mg
Avregistreringsdatum: 2020-01-31 (Tillhandahålls ej)

Blisterkartan är märkt både LISINOPRIL 2CARE4 och Lisinopril. Bortse från veckodagsmarkering på främmande språk.

ACE-hämmare.

Visa information om det parallellimporterade läkemedlet
Aktiv substans:
ATC-kod: C09AA03
För information om det avregistrerade läkemedlet omfattas av Läkemedelsförsäkringen, kontakta Läkemedelsförsäkringen.
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Miljöinformation

Miljöpåverkan (Läs mer om miljöpåverkan)

Miljöinformationen för lisinopril (vattenfri) är framtagen av företaget AstraZeneca för Lisinopril AstraZeneca, Zestoretic, Zestril®

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


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Detaljerad miljöinformation

PEC/PNEC = 0.0062 μg/L /120 μg/L = 0.000052

PEC/PNEC = ≤ 0.1


Environmental Risk Classification


Predicted Environmental Concentration (PEC)

The PEC is based on following data:


PEC (µg/L) = (A*109*(100-R))/(365*P*V*D*100)


PEC (µg/L) = 1.5*10-6*A*(100-R)


A (kg/year) = total sold amount API in Sweden year 2017, data from IQVIA (former IMS Health and Quintiles).

R (%) = 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. 1)

D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (Ref. 1)

(Note: The factor 109 converts the quantity used from kg to μg).


A = 41.3 kg

R = 0

PEC = 1.5 * 10-6 * 41.3 * (100-0) = 0.0062 µg/L


Metabolism

Lisinopril dihydrate is not metabolised in the body, with virtually 100% excreted via urine as the parent drug (Ref. 2).


Ecotoxicity data

Endpoint

Species

Common name

Method

Time

Result

Ref

EyC50 - Based on Biomass

Pseudo­kirchneriella sub­capitata (formerly known as Sele­nastrum capri­cornutum)

Green Alga

OECD 201

72 h

>120 mg/L

3

NOEC - Based on Biomass

120 mg/L

LOEC - Based on Biomass

>120 mg/L

ErC50 - Based on Growth Rate

>120 mg/L

NOEC - Based on Growth Rate

120 mg/L

LOEC - Based on Growth Rate

>120 mg/L

NOEC - Based on Immobil­isation

Daphnia magna

Giant Water Flea

OECD 202

48 h

120 mg/L

4

LOEC - Based on Immobil­isation

>120 mg/L

LC50

Oncorhynchus mykiss

Rainbow Trout

84/449/EEC C1

96 h

>1060 mg/L

5

NOEC - Based on Mortality & Symptoms of Toxicity

1060 mg/L

Percentage BOD Inhibition

-

-

DOE 1977

5 d

0% @ 60 mg/L

6

Percentage Respiration Inhibition

-

-

Modified OECD 209

4 – 6 min

2.1% @ 100 mg/L

7

Percentage Inhibition of Anaerobic Gas Production

-

-

DoE 1987

15 d

0% @ 529 mg/L

8


PNEC (Predicted No Effect Concentration)

Short-term tests have been undertaken for species from three trophic levels, based on internationally accepted guidelines. Therefore, the PNEC is based on the acute toxicity (E/LC50) to the giant water flea (Daphnia magna) and the green alga (Pseudokirchneriella subcapitata) studies, as the species with the lowest NOECs, and an assessment factor of 1000 is applied, in accordance with ECHA guidance (Ref. 9).


PNEC = 120 000/1000 µg/L = 120 µg/L


Environmental risk classification (PEC/PNEC ratio)


PEC/PNEC = 0.0062 μg/L /120 μg/L =0.000052, i.e PEC/PNEC = ≤0.1 which justifies the phrase "Use of lisinopril dihydrate has been considered to result in insignificant environmental risk."


In Swedish: "Användning av lisinoprildihydrat har bedömts medföra försumbar risk för miljöpåverkan.” under the heading ”Miljörisk”.


Environmental Fate Data

Endpoint

Method

Test Substance Concentration

Time

Result

Ref.

Partition Coefficient Octanol Water

Not specified

-

-

LogP = 1.01

10

BOD

DOE 1977

1 mg/L

5 d

0.16 gO2/g

6

BOD

60 mg/L

< 0.01 gO2/g

Percentage Aerobic Biodegradation

OECD 301C

20 mg/L

28 d

0 %

11

Percentage DOC Removal

OJ 88/L133/106-117

10 mg/L as Carbon

18 - 39 d

<20%


Biotic degradation

Lisinopril dihydrate is not readily biodegradable in accordance to the OECD 301C (Ref. 11), with 0% biodegradation after 28 days. Based on this information (considering that no other data is available) the substance has been assigned the risk phrase: "Lisinopril dihydrate is potentially persistent."


In Swedish: “Lisinoprildihydrat är potentiellt persistent.” under the heading “Nedbrytning”.


Bioaccumulation

Since Log P < 4 the phrase "Lisinopril dihydrate has low potential for bioaccumulation” is assigned.


In Swedish: ”Lisinoprildihydrat har låg potential att bioackumuleras.” under the heading “Bioackumulering”.


Physical Chemistry Data

Endpoint

Method

Test Conditions

Result

Reference

Dissociation Constant

Not Specified

25°C

pKa1 = 2.5

pKa2 = 4.0

pKa3 = 6.7

pKa4 = 10.1

10

Solubility Water

Not specified

-

97000 mg/L

10


References

  1. [ECHA] European Chemicals Agency. Guidance on Information Requirements and Chemical Safety Assessment. Chapter R.16: Environmental exposure assessment (Version 3.0). February 2016.


  2. Electronic Medicines Compendium, SmPC Zestril (5 mg, 10 mg and 20 mg tablets). https://www.medicines.org.uk/emc/ (accessed September 2019).


  3. Lisinopril dihydrate: Determination of toxicity to the green alga Pseudokirchneriella subcapitata. Brixham Environmental Laboratory, AstraZenca, UK, Report BR0485. August 2010.


  4. Lisinopril dihydrate: Determination of the acute toxicity to Daphnia magna. Brixham Environmental Laboratory, AstraZencam, UK, Report BR0481. August 2011.


  5. Lisinopril dihydrate: Determination of acute toxicity to rainbow trout (Salmo gairdneri). Brixham Environmental Laboratory, AstraZenca, UK, Report BL3660. May 1991.


  6. Lisinopril dihydrate: Inhibition of 5 day BOD and determination of COD and total carbon. Brixham Environmental Laboratory, AstraZenca, UK, Report 3726. March 1990.


  7. Lisinopril dihydrate: Determination of activated sludge respiration inhibition, total carbon (TC) and chemical oxygen demand (COD). Brixham Environmental Laboratory, AstraZenca, UK, Report BL3657. February 1990.


  8. BL3659 Lisinopril dihydrate: Determination of anaerobic sludge digestion inhibition. Brixham Environmental Laboratory, AstraZenca, UK, Report BL3659. February 1990.


  9. [ECHA] European Chemicals Agency. Guidance on Information Requirements and Chemical Safety Assessment. Chapter R.10: Characterisation of dose [concentration]-response for environment. May 2008.


  10. The Merck Index. An Encyclopaedia of Chemicals, Drugs and Biologicals. 12th Edition. Budavari S. ; O'Neil M.J. ; Smith A. ; Heckelman P.E. ; Kinneary J.F. ; (Editors). Merck 1996.


  11. Lisinopril dihydrate: Determination of toxicity and biodegradability by modified OECD test guideline 303a. Brixham Environmental Laboratory, AstraZenca, UK, Report BL3658. February 1991.