Miljöpåverkan
Saccharomyces boulardii, stam CNCM I-745, frystorkad
Miljörisk:
Användning av saccharomyces boulardii, stam cncm i-745, frystorkad bedöms inte medföra någon miljöpåverkan.
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Detaljerad miljöinformation
English: Use of Saccharomyces boulardii, strain CNCM I-745 has been considered to result in insignificant environmental impact.
Saccharomyces boulardii CNCM I-745 is a tropical strain of yeast first isolated from lychee and mangosteen fruit. It is related to, but distinct from, S. cerevisiae in several taxonomic, metabolic, and genetic properties. Saccharomyces boulardii CNCM I-745 has been shown to maintain and restore the natural flora in the large and small intestine; it is classified as a probiotic. Saccharomyces boulardii CNCM I-745 has been shown to be non-pathogenic, non-systemic (it remains in the gastrointestinal tract and do not spread elsewhere in the body), and grows at the unusually high temperature of 37°C.
Saccharomyces boulardii CNCM I-745 is not metabolised by Human and is released unchanged into the environment. Any release that does occur will be through disposal of unused drug by patient. Entry into the environment will occur principally through the sewage system with a potential for extremely low concentrations to be present transiently in surface water.
All the excipients used in Precosa are well established for pharmaceutical products and are not expected to pose any environmental risk taking into account the quantities used.
No precautionary measures are considered necessary regarding the environmental release following the use of Precosa in patients.
Should any Precosa reach the environment through disposal of unused product, the environment risk is considered to be minimal. As with all unused medicinal products, appropriate disposal procedures should be employed.
In Swedish: Enligt den europeiska läkemedelsmyndigheten EMA:s riktlinjer för miljöriskbedömningar av läkemedelssubstanser (EMA/CHMP/SWP/4447/00), är vitaminer, elektrolyter, aminosyror, peptider, proteiner, kolhydrater, lipider, vacciner och växtbaserade läkemedel undantagna då de inte bedöms medföra någon betydande risk för miljön.
Även om biomolekyler är undantagna från miljöriskklassificering bör det beaktas att dessa molekyler kan vara biologiskt aktiva.
In English: According to the European Medicines Agency 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.
Even though biomolecules are exempted from environmental risk classification it should be remembered that these molecules may be biologically active.