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Zoladex®

Miljöinformation
Receptstatus
Förmånsstatus
AstraZeneca

Implantat i förfylld spruta 3,6 mg
(vit till krämfärgad stav, 12×1 mm)

Gonadotropinfrisättande hormonanaloger

Aktiv substans:
ATC-kod: L02AE03
Utbytbarhet: Utbytbara läkemedel
Läkemedel från AstraZeneca omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöinformation

Miljöpåverkan

Goserelin

Miljörisk: Användning av aminosyror, proteiner och peptider bedöms inte medföra någon miljöpåverkan.


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Detaljerad miljöinformation

Goserelin is a peptide and as such is considered to result in insignificant environmental impact. According to the EU EMA guideline for Environmental Risk Assessment of pharmaceuticals vitamins, electrolytes, amino acids, peptides, proteins, carbohydrates and lipids are exempted because they are unlikely to result in significant risk to the environment (Ref. 1).


Therefore the statement:


“The use of amino peptides has been considered to result in insignificant environmental impact. “


In Swedish: ”Användning av peptider bedöms inte medföra någon miljöpåverkan.” 


Environmental information is available (see table below), which confirms that goserelin is readily biodegradable (i.e. is completely mineralised under aerobic test conditions) and would be expected to be removed completely in a sewage treatment plant.

Therefore, goserelin is not likely to enter the environment and is consequently not predicted to present a significant risk for the environment (Ref. 2 and 3).


Environmental Fate Data

Endpoint

Method

Test Substance Concentration

Time

Result

Ref

Aerobic Biodegradation

OECD301F

50 mg/L and 100mg/L

28 d

90% and 85%

biodegradradation, no detectable parent remaining at end of study

2

Anaerobic Biodegradation

ISO Draft Method ISO/CD11734

100mg/L

56 d

33% anaerobic

biodegradradation, no detectable parent remaining at end of study

3

References

  1. Committee for Medicinal Products for Human Use (CHMP); Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use. 1 June 2006, Ref EMEA/CPMP/SWP/4447/00.


  2. Zoladex: Determination of Ready Biodegradability by OECD Test Guideline 301F. Brixham Environmental Laboratory, Astrazeneca, UK. Report BLS1737. October 1994.


  3. Zoladex: Determination of Anaerobic Biodegradability. Brixham Environmental Laboratory, Astrazeneca, UK. Report BLS1738. October 1994.

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