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 och länkar

Sök apotek med läkemedlet i lager

Sök lagerstatus

Arimidex®

MiljöinformationReceptstatusFörmånsstatus
AstraZeneca

Filmdragerad tablett 1 mg
(vita, runda, bikonvexa, märkta med ’A’ på en sida och ’Adx1’ på den andra sidan, ca 6,1 mm)

Medel mot tumörer, endokrint verksamt

Aktiv substans:
ATC-kod: L02BG03
Läkemedel från AstraZeneca omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöpåverkan (Läs mer om miljöpåverkan)

Anastrozol

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


Läs mer

Detaljerad miljöinformation


PEC/PNEC = 0.0004 μg/L /1 μg/L =0.00039

PEC/PNEC < 0.1


Environmental Risk Classification

Predicted Environmental Concentration (PEC)



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 2015, data from IMS Health.

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 = 2.6 kg.


R = 0


PEC = 1.5 * 10-6 * 2.6 * (100-0) = 0.00039 µg/L


(Note, whilst anastrozole is extensively metabolised in humans, little is known about the ecotoxicity of the metabolites. Hence, as a worst case, for the purpose of this calculation, it is assumed that 100% of excreted metabolites have the same ecotoxicity as parent anastrozole.)


Metabolism

Anastrozole is extensively metabolised and <10% is excreted as parent via the urine within 72 hours of dosing. The remainder is excreted as metabolites which are formed via N-dealkylation, hydroxylation and glucuronidation, and they are mainly excreted via the urine. The main metabolite, triazole, does not exhibit aromatase inhibiting properties (Ref. 2).


Ecotoxicity data

Endpoint

Species

Common Name

Method

Time

Result

Ref.

LOEC - Based on Largest Specific Growth Rates

Microcystis aeruginosa

Cyanobacte-rium (Blue-Green Alga)

US FDA Technical Assistance Document 4.01

21 d

6.0 mg/L

3

LOEC - Based on Maximum Standing Crops

3.0 mg/L

NOEC - Based on Largest Specific Growth Rates

3.0 mg/L

NOEC - Based on Maximum Standing Crops

1.5 mg/L

ErC50 - Based on Largest Specific Growth Rates

96 h

>48 mg/L

LOEC - Based on Largest Specific Growth Rates

Pseudokirchne-riella subcapitata (formerly known as Selenastrum capricornutum)

Green Alga

US FDA Technical Assistance Document 4.01

14 d

81 mg/L

4

LOEC - Based on Maximum Standing Crops

81 mg/L

NOEC - Based on Largest Specific Growth Rates

27 mg/L

NOEC - Based on Maximum Standing Crops

27 mg/L

ErC50 - Based on Largest Specific Growth Rates

96 h

31.3 ml/L

LOEC – Based on Reproduction & Length

Daphnia magna

Giant Water Flea

US FDA Technical Assistance Document 4.09

21 d

5.6 mg/L

5

NOEC – Based on Reproduction & Length

3.2 mg/L

LC50

Lepomis

macrochirus

Bluegill Sunfish

US FDA

Technical Assistance Document 4.11

96 h

84 mg/L

6

NOEC – Based on Symptoms of Toxicity

10 mg/L


LC50

Oncorhynchus mykiss

Rainbow Trout

US FDA Technical Assistance Document 4.11

96 h

75 mg/L

7

NOEC – Based on Symptoms of Toxicity

32 mg/L

NOEC – Based on All Population Relevant Endpoints

Pimephales promelas

Fathead Minnow

Extended OECD 210 Reduced fish full life-cycle, starting with embryos

104 d

0.01 mg/L

8

LOEC – Based on All Population relevant Endpoints

>0.01 mg/L


PNEC (Predicted No Effect Concentration)

Long-term tests have been undertaken for species from three trophic levels, based on internationally accepted guidelines. Therefore, the PNEC is based on toxicity to fathead minnow (Pimephales promelas), the most sensitive species, and an assessment factor of 10 is applied, in accordance with ECHA (Ref. 9).


Environmental risk classification (PEC/PNEC ratio)

PNEC = 10/10 µg/L = 1.0 µg/L

PEC/PNEC = 0.0004 μg/L /1 μg/L =0.00039

PEC/PNEC ≤ 0.1


The PEC/PNEC ratio decides the wording of the aquatic environmental risk phrase, and the risk phrase for PEC/PNEC ≤ 0.1 “Use of anastrozole has been considered to result in insignificant environmental risk” has been assigned.


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


Environmental Fate Data

Endpoint

Method

Test Substance Concentration

Time

Result

Ref.

Biochemical Oxygen Demand

OECD301F

50 & 100 mg/L

28 d

0 g O2/g

10

Percentage Aerobic Biodegradation

< 5 % by carbon & test substance loss from aqueous phase

Percentage Anaerobic Biodegradation

DoE 1998 modified according to ISO Committee Draft CD11734 1993

25 & 50 mg/L (as Carbon)

55 d

0 % by gas production, carbon and test substance loss from aqueous phase

11


Biodegradation

Anastrozole is not readily biodegradable. Based on this data (considering that no other data is available), the phrase ‘Anastrozole is potentially persistent.’ is assigned.


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


Bioaccumulation


Log P (experimental) = 1.58


Anastrozole has no significant bioaccumulation potential, as indicated by the log P. Therefore the statement “Anastrozole has low potential for bioaccumulation” is assigned.


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


Physical Chemistry Data

Endpoint

Method

Concentration

Test Conditions

Results

Ref.

Soil Adsorption

US FDA

Technical Assistance Document 3.08

25 mg/L (Nominal)

Nebo Soil:

28 % Clay

19 % Sand

53 % Silt

pH 5.0

1.45 % organic carbon

Koc = 1100

12

East Jubilee Soil:

13 % Clay

70 % Sand

17 % Silt

pH 5.8

2.2 % organic carbon

Koc = 180

Kenny Hill Soil:

14 % Clay

78 % Sand

8 % Silt

pH 7.7

3.1 % organic carbon

Koc = 63

Water Solubility

- Method unkown

-

25ºC

500 mg/L

13

Dissociation Constant

- Method unknown

-

-

pKa = 1.4

13

Partition Coefficient Octanol Water

Method unknown

-

-

Log P= 1.58

13


References

1. [ECHA] European Chemicals Agency. February 2016. Guidance on Information Requirements and Chemical Safety Assessment. Chapter R.16: Environmental exposure assessment (version 3.0) http://echa.europa.eu/documents/10162/13632/information_requirements_r16_en.pdf


2. Electronic Medicines Compendium https://www.medicines.org.uk/emc/(accessed July 2016).


3. Arimidex: Toxicity to the Blue-green alga, Microcystis aeruginosa. Brixham Environmental Laboratory, AstraZeneca, UK, Report BL4897, November 1993.

4. Arimidex: Toxicity to the green alga, Selenastrum capricornutum.

Brixham Environmental Laboratory, AstraZeneca, UK, Report BL4896, November 1993.


5. Arimidex: Chronic toxicity to Daphnia magna. Brixham Environmental Laboratory, AstraZeneca, UK, Report BL4998, November 1993.


6. Arimidex: Acute toxicity to Bluegill sunfish (Lepomis macrochirus). Brixham Environmental Laboratory, AstraZeneca, UK, Report BL5221, December 1994.


7. Arimidex: Acute toxicity to rainbow trout (Oncorhynchus mykiss). Brixham Environmental Laboratory, AstraZeneca, UK, Report BL5220. November 1994.


8. Anastrazole: Determination of the effect on development, growth and spawning ability, of the fathead minnow (Pimephales promelas). Brixham Environmental Laboratory, AstraZeneca, UK, Report BR0180, April 2011.


9. ECHA, European Chemicals Agency. Guidance on Information Requirements and Chemical Safety Assessment. Chapter R10. May 2008. http://echa.europa.eu/documents/10162/13632/information_requirements_r10_en.pdf


10. Arimidex: Determination of 28 day ready biodegradability. Brixham Environmental Laboratory, AstraZeneca, UK, Report BL4999, November 1993.


11. Arimidex: Determination of anaerobic biodegradability. Brixham Environmental Laboratory, AstraZeneca, UK, Report BL5020, November 1993.


12. Arimidex: Soil sorption and desorption. Brixham Environmental Laboratory, AstraZeneca, UK, Report BL5014/B, November 1993.


13. Marketing: S.1.3 General Properties. Anastrozole. AstraZeneca, October 2010.

Välj läkemedelstext
Hitta direkt i texten
Av