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Fosavance®

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MSD

Tablett 70 mg/2800 IE
(Kapselformade vita till vitaktiga, märkta med konturen av ett ben på ena sidan och "710" på den andra sidan.)

Medel som påverkar benvävnad och mineralisering, Bisfosfonater och kalcium

ATC-kod: M05BB03
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  • Vad är miljöinformation?

Miljöpåverkan (Läs mer om miljöpåverkan)

Alendronsyra

Miljörisk: Användning av alendronsyra har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning: Alendronsyra bryts ned långsamt i miljön.
Bioackumulering: Alendronsyra 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 = 0.04 μg/L


Where:

A = 257 kg (total sold amount API in Sweden year 2016, data from QuintilesIMS).

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) (OECD 201) (Ref. II):

EC50 72 h (yield) = 5.5 mg/L

EC50 72 h (growth rate) > 10 mg/L

NOEC = 4 mg/L


Crustacean, water flea (Daphnia magna):

Acute toxicity

EC50 48 h (mortality) = 170 mg/L (OECD 202) (Ref. III)


Chronic toxicity

NOEC 21 d (survival) = 4.7 mg/L (OECD 211) (Ref. IV)


Fish, fathead minnow (Pimephales promelas):

Acute toxicity

LC50 96 h (mortality) = 27 mg/L (OECD 203) (Ref. V)


Chronic toxicity

NOEC 32 d (growth) = 1.1 mg/L (OECD 210) (Ref. VI)


PNEC = 110 μg/L (1.1 mg/L / 10 based on the most sensitive NOEC for the fathead minnow and an assessment factor (AF) of 10)


Environmental risk classification (PEC/PNEC ratio)

PEC/PNEC =0.04/110 = 0.0004, i.e. PEC/PNEC ≤ .1 which justifies the phrase "Use of alendronate has been considered to result in insignificant environmental risk.”


Degradation

Biotic degradation

Inherent degradability:

Elimination of alendronate from the activated sludge test solutions occurred steadily over the 28-day test. Test substance concentrations decreased by 70.6% within 7 days and indicate that alendronate undergoes inherent primary biodegradation. Additionally, the 70.3% decline of TOC in the activated sludge indicates that alendronate also undergoes some ultimate biodegradation by

converting to CO2. Therefore, alendronate can be classified as inherently, primarily biodegradable, without pre-adaption to the inoculum according to the OECD Guidelines and is not expected to persist in the environment. (OECD 302B). (Ref. VII)


Abiotic degradation

Hydrolysis:

Predicted hydrolysis half-life of 413, 375, and 223 days at pH 5, 7, and 9, respectively (US FDA 3.09). (Ref. VIII)


Photolysis:

No photolysis evident over 167 hours (US FDA 3.10) (Ref. IX)


Justification of chosen degradation phrase:

Alendronate is classified as inherently, primarily biodegradable, therefore the phrase “Alendronate is slowly degraded in the environment” is thus chosen.


Bioaccumulation

Partitioning coefficient:

Log Kow =-1.73 (OECD 107). (Ref. X)


Justification of chosen bioaccumulation phrase:

Since log Kow < 4 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. Toxikon Corporation, 2003b. "Alendronate sodium®: Acute toxicity to freshwater green alga, Selenastrum capricornutum, under static test conditions" OECD Guideline 201, Toxikon Corporation, Jupiter, Fl, USA, 27 June, 2003.


III. Toxikon Corporation, 2003a. "Alendronate sodium®: Acute toxicity to the water flea, Daphnia magna, under static test conditions", OECD Guideline 202, Toxikon Corporation, Jupiter, Fl, USA, 11 April, 2003.


IV. Smithers Viscient, 2015. "Alendronate Sodium - Full Life-Cycle Toxicity Test with Water Fleas, Daphnia magna, Under Static Renewal Conditions Following OECD Guideline #211" Report 359.6843, Wareham, MA, USA.


V. Toxikon Corporation, 2003c. "Alendronate sodium®: Acute toxicity to fathead minnow, Pimephales promelas, under static test conditions" OECD Guideline 203, Toxikon Corporation, Jupiter, Fl, USA, 15 September, 2003.


VI. Smithers Viscient, 2015. "Alendronate Sodium – Early Life-Stage Toxicity Test with Fathead Minnow (Pimephales promelas)" Report 359.6842, Wareham, MA, USA.


VII. Smithers Viscient, 2015. "Alendronate – Determination of the Biodegradability of a Test Substance Based on OECD Method 302B (Zahn-Wellens/EMPA Test)" Report 359.6844, Wareham, MA, USA..


VIII. SRC, 1992f. "Report for determining the rate of hydrolysis for the Merck & Co., Inc. product MK-0217", Syracuse Research Corporation, Syracuse, NY, USA, 17 August, 1992.


IX. SRC, 1992c. "Report for Assessing the photodegradation of the Merck & Co., Inc. test substance MK-0217 (alendronate)", Syracuse Research Corporation, Syracuse, NY, USA, 22 July, 1992.


X. Toxikon Corporation, 2004. "Alendronate sodium®: Partition coefficient (n-Octanol/water): shake flask method" OECD Guideline 107, Toxikon Corporation, Bedford, MA, USA, 30 January 2004.



Kolekalciferol

Miljörisk: Användning av vitaminer bedöms inte medföra någon miljöpåverkan.


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Detaljerad miljöinformation

According to the European Medicines Agency guideline on environmental risk assessments for pharmaceuticals (EMA/CMP/SWP/4447/00), vitamins, electrolytes, amino acids, peptides, proteins, carbohydrates, lipids, vaccines and herbal medicinal products are exempted because they are unlikely to result in significant risk to the environment (Ref. I).


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

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