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Kommersiellt obunden läkemedelsinformation riktad till läkare och sjukvårdspersonal



Fara - P - B - T - Risk Undantagen

Fass miljöinformation

Fass miljöinformation för Simulect (basiliximab) från Novartis (hämtad 2019-07-10).

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

"Use of amino acids/peptides/proteins has been considered to result in insignificant environmental impact. In the case of products containing vitamins, electrolytes, amino acids, peptides, proteins, carbohydrates and lipids as active pharmaceutical ingredient(s), an ERA should be provided. This ERA may consist of a justification for not submitting ERA studies, e.g. due to their nature they are unlikely to result in a significant risk to the environment. The same applies to vaccines and herbal medicinal products (European Medicines Agency guideline on Doc. Ref. EMEA/CHMP/SWP/4447/00 corr 2). It can be expected that any medicinal absorbed monoclonal antibody is completely metabolized and adsorbed in the body. Any medicinal product that reaches water streams via eventual spills during application or after disposal of unused drug is expected to be very rapidly degraded and mineralized to CO2 by microbial activity."

Författad vid avdelningen Kunskapsutveckling, Region Stockholm