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Företaget deltar inte i Fass, därför finns endast begränsad information om läkemedlet.

Lorzaar

(Parallellimporterat)
Cross Pharma AB

Filmdragerad tablett 100 mg
Avregistreringsdatum: 2009-12-31 (Tillhandahålls ej)

Blisterkartan är märkt både Lozaar protect och Lozaar

Angiotensin II-antagonist

Visa information om det parallellimporterade läkemedlet
Aktiv substans:
ATC-kod: C09CA01
För information om det avregistrerade läkemedlet omfattas av Läkemedelsförsäkringen, kontakta Läkemedelsförsäkringen.
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Miljöinformation

Miljöpåverkan (Läs mer om miljöpåverkan)

Miljöinformationen för losartan är framtagen av företaget MSD för Cozaar®, Cozaar® Comp, Cozaar® Comp Forte, Fortzaar mite

Miljörisk: Användning av losartan har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning: Losartan är potentiellt persistent.
Bioackumulering: Losartan 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 = 1.2 μg/L


Where:

A = 8161 kg (total sold amount API in Sweden year 2015, data from IMS Health).

R = 0 % removal rate (worst case assumption)

P = number of inhabitants in Sweden = 9 *106

V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (Ref. I)

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


Predicted No Effect Concentration (PNEC)


Ecotoxicological studies


Green Algae (Selenastrum capricornutum) (FDA 4.01) (Ref. II):

NOEC 10 day (cell growth) = 143 mg/L


Blue Green Algae (Microcystis aeruginosa)(FDA 4.01) (Ref. III): NOEC 10 day (cell growth) = 556 mg/L


Crustacean, water flea (Daphnia magna):

Acute toxicity

LC50 48 h (mortality) = 331 mg/L (OECD 202) (Ref.IV)

NOEC = 80 mg/L


Chronic toxicity

NOEC 21 day (survival, reproduction, growth) = 100 mg/L (OECD 211) (Ref V)

No effects noted up to the highest concentration tested


Fish, fathead minnow (Pimephales promelas):

Acute toxicity

LC50 48 h (mortality) > 1000 mg/L (U.S. EPA “Methods for Measuring the Acute Toxicity of Effluents to Fresh Water and Marine Organisms”, 1985) (Ref.IV)

NOEC = 100 mg/L


Chronic toxicity

NOEC 32-day (survival, hatching, growth) = 10 mg/L (OECD 210) (Ref VI)

No effects noted up to the highest concentration tested


Fish, rainbow trout (Oncorhynchus mykiss):

Acute toxicity

LC50 96 h (mortality) > 929 mg/L (FDA 4.11) (Ref.VII)

NOEC = 929 mg/L


PNEC = 1000 μg/L (10000 μg/L/ 10 based on the most sensitive chronic NOEC for the fish with an assessment factor (AF) of 10)


Environmental risk classification (PEC/PNEC ratio)

PEC/PNEC = 1.2/1000 = 0.001, i.e. PEC/PNEC ≤ .1 which justifies the phrase “Use of losartan has been considered to result in insignificant environmental risk.”


Degradation


Biotic degradation


Bacteria > 90% of initial concentration remaining

Algal = 71% of initial concentration remaining after 28 days (FDA 3.11). (Ref VIII)


Abiotic degradation

Hydrolysis:

Hydrolytically stable between pH 5-9 (FDA 3.09). (Ref. IX)


Photolysis:

Susceptible to aqueous photolysis and rapidly degrades under clear sky conditions

Half-Lifemax < 18 hours (pH 9) over wavelength interval 290-800 nm

(FDA 3.10). (Ref. X)


Justification of chosen degradation phrase:

Losartan has been found to degrade under natural light conditions however no data are available on metabolites. Therefore the phrase “Losartan is potentially persistent” was thus chosen.


Bioaccumulation

Partitioning coefficient:

Log Kow = 1.2 (OECD 107). (Ref.XI)


Justification of chosen bioaccumulation phrase:

Since log Kow < 4 at pH 7, the substance has low potential for bioaccumulation


References


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

  2. Toxikon Environmental Sciences, 1993. "Losartan (MK-0954): Toxicity to the Freshwater Green Alga, Selenastrum capricornutum, Under Static Test Conditions," Study No., J9209001f, TOX, Jupiter, FL, USA, 16 June 1993.

  3. Toxikon Environmental Sciences, 1993. "Losartan (MK-0954): Toxicity to the Blue-Green Alga, Microcystis aeruginosa, Under Static Test Conditions," Study No., J9209001g, TOX, Jupiter, FL, USA, 16 June 1993.

  4. Merck, 1995. “ Environmental Quality Criteria Monograph for Losartan Potassium”, Merck & Co., Inc. Whitehouse Station, NJ, USA, 24 November 1995.

  5. Smithers Visicent, 2013. "Losartan – Full Life-Cycle Toxicity Test with Water Fleas, Daphnia magna, Under Static Renewal Conditions Following OECD Guideline #211" Smithers Viscient Study Number 359.6707" Wareham, MA, USA, 18 June 2013.

  6. Smithers Visicent, 2013. "Losartan – Early Life-Stage Toxicity Test with Fathead Minnow, Pimephales promelas, Following OECD Guideline #210" Smithers Viscient Study Number 359.6706" Wareham, MA, USA, 10 June 2013.

  7. Toxikon Environmental Sciences, 1993. "Losartan (MK-0954): Acute Toxicity to Rainbow Trout, Oncorhynchus mykss, Under Static Test Conditions," Study No., J9209001i, TOX, Jupiter, FL, USA, 28 May 1993.

  8. Toxikon Environmental Sciences, 1993. "Losartan (MK-0954): Biodegradation Inoculum Source Screening and Aerobic Biodegradation in Water," Study No., J9209001d, TOX, Jupiter, FL, USA, 06 August 1993.

  9. Toxikon Environmental Sciences, 1993. "Losartan (MK-0954): Determination of the Rate of Hydrolysis as a Function of pH," Study No., J9209001b, TOX, Jupiter, FL, USA, 02 March 1993.

  10. Toxikon Environmental Sciences, 1993. "Losartan (MK-0954): Determination of Aqueous Photolysis," Study No., J9209001c, TOX, Jupiter, FL, USA, 02 July 1993.

  11. Merck & Co., Inc., 1995 “New Drug Application for Tablets Losartan Potassium, Environmental Assessment, Feb 1 1995”