Läs upp

Cookies

Den här webbplatsen använder så kallade cookies. Cookies är små textfiler som lagras i din dator och sparar information om olika val som du gjort på en webbsida – t ex språk, version och statistik – för att du inte ska behöva göra dessa val en gång till. Tekniken är etablerad sedan många år tillbaka och används idag på väldigt många webbplatser på Internet.

Du kan när som helst ändra cookieinställningarna för denna webbplats.

FASS logotyp
Receptbelagd

Peka på symbolerna och beteckningarna till vänster för en förklaring.

Kontakt

Sök apotek med läkemedlet i lager

Sök lagerstatus

Januvia®

MSD

Filmdragerad tablett 50 mg
(Rund, ljustbeige, märkt 112 på ena sidan)

Diabetesmedel, Dipeptidylpeptidas-4 (DPP 4) hämmare

Aktiv substans:
ATC-kod: A10BH01
Läkemedel från MSD omfattas av Läkemedelsförsäkringen.
Läkemedlet distribueras också av företag som inte omfattas av Läkemedelsförsäkringen, se Förpackningar.
  • Vad är miljöinformation?

Miljöinformation

Miljöpåverkan (Läs mer om miljöpåverkan)

Sitagliptin

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


Läs mer

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 = 0.21 μg/L


Where:

A = 1379 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 (Pseudokirchneriella subcapitata) (OECD 201) (Ref. II):

EC50 72 h (growth rate) > 39 mg/L

NOEC = 0.84 mg/L


Crustacean, water flea (Daphnia magna):

Acute toxicity

EC50 48 h (immobility) = 60 mg/L (OECD 202) (Ref. III)

NOEC = 25 mg/L


Chronic toxicity

NOEC 21 day (survival, reproduction, and growth) = 9.8 mg/L (OECD 211) (Ref. IV)

No effects seen up to highest concentration tested


Fish, fathead minnow (Pimephales promelas):

Acute toxicity

LC50 96 h (mortality) > 100 mg/L (OECD 203) (Ref.V)

NOEC = 100 mg/L

No effects seen up to highest concentration tested


Chronic toxicity

NOEC 33 days (percent live normal fry, total length and dry weight) = 9.2 mg/L (OECD 210) (Ref. VI)

No effects seen up to highest concentration tested


PNEC = 84 μg/L (840 μg/L/ 10 based on the most sensitive chronic NOEC for the green algae with an assessment factor (AF) of 10)


Environmental risk classification (PEC/PNEC ratio)

PEC/PNEC = 0.21/84 = 0.002, i.e. PEC/PNEC ≤ .1 which justifies the phrase "Use of sitagliptin has been considered to result in insignificant environmental risk.”


Degradation


Biotic degradation


Test results 7 % degradation in 28 days (OECD 302B). (Ref. VII)


  • Test results 75% elimination (loss of parent) at Day 28, 40% evolved as CO2.
    DT50 for loss of parent = 21.1 hours; DT50 for CO2 production = 108 days. (OECD 314). (Ref VIII)


Abiotic degradation

Hydrolysis:

No significant degradation (Half life = 895 days at pH 7) (OECD 111). (Ref. IX)


Photolysis:

No potential for phototransformation between 295 and 800 nm (OECD 316). (Ref. X)


Justification of chosen degradation phrase:

Sitagliptin is slightly biodegradable in biological systems and does not meet the criteria for ready degradability (70% degradation in 7 days criterion was not met). In addition, the half-life in sludge for mineralization (108 days) is greater than the REACH persistence criterion for water (>40 days), although less than the criterion for sediment (>120 days). Sitagliptin does not undergo hydrolysis or photolysis, therefore the phrase “Sitagliptin is potentially persistent in the environment” was thus chosen.


Bioaccumulation

Partitioning coefficient:

Log Kow = -0.03 at pH 7 (OECD 107). (Ref.XI)


Justification of chosen bioaccumulation phrase:

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



References

I. 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


II. Wildlife International, 2009. "Sitagliptin: A 96-Hour Toxicity Test with the Freshwater Alga (Pseudokirchneriella subcapitata)," Project No., 105A-187A, WIL, Easton, MD, USA, 01 June 2009.


III. Toxikon Corporation, 2004. "MK-0431: Acute Toxicity to the Water Flea, Daphnia magna, Under Static Conditions," Study No., 04J0005a, Jupiter, FL, USA, 08 July 2004.


IV. Wildlife International, 2006. "MK-0431: A Flow-Through Life-Cycle Toxicity Test with the Cladoceran (Daphnia magna)," Project No., 105A-146, WIL, Easton, MD, USA, 27 June 2006.


V. Toxikon Corporation, 2004. "MK-0431: Acute Toxicity to Fathead Minnow, Pimephales promelas, Under Static Conditions," Study No., 04J0005b, Jupiter, FL, USA, 29 June 2004.


VI. Wildlife International, 2006. "MK-0431: An Early Life-Stage Toxicity Test with the Fathead Minnow (Pimephales promelas)," Project No., 105A-147, WIL, Easton, MD, USA, 05 July 2006


VII. Wildlife International, 2005. "MK-0431: An Evaluation of Inherent Biodegradability Using the Zahn-Wellens/EMPA Test," Project No., 105E-108, WIL, Easton, MD, USA, 07 December 2005.


VIII. Wildlife International, 2009. "[14C] MK-0431:Biodegradation in Activated Sludge," Project No., 105E-146, WIL, Easton, MD, USA, 17 September 2009.


IX. Wildlife International, 2005. "MK-0431: An Evaluation of Hydrolysis as a Function of pH," Project No., 105C-102, WIL, Easton, MD, USA, 07 December 2005.


X. Wildlife International, 2005. " Phototransformation Potential of MK-0431," Project No., 105C-103, WIL, Easton, MD, USA, 02 December 2005.


XI. Wildlife International, 2009. "Determination of n-Octanol/Water Partition Coefficient of MK-0431 by the Shake Flask Method," Project No., 105C-118, WIL, Easton, MD, USA, 27 January 2009.