Miljöpåverkan
Oktokog alfa
Miljörisk:
Användning av aminosyror, proteiner och peptider bedöms inte medföra någon miljöpåverkan.
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Detaljerad miljöinformation
Octocog alfa (recombinant factor VIII) is a glucoprotein exhibiting anti-haemophilic activity. It has the identical structure of the human factor VIII.
The protein octocog alfa is quickly metabolized in the human body and considered to be readily biodegradable in the environment. Risk or hazard in the environment is not expected.
According to the European Medicines Agency (EMA) guideline on environmental risk assessments for pharmaceuticals (EMA/CHMP/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.
Generally, even though biomolecules are exempted from environmental risk classification it should be remembered that these molecules may be biologically active.
In conclusion, octocog alfa is exempted from the requirement to conduct a risk assessment.