Filgrastim is indicated for the treatment of white blood cell shortages, for harvesting of stem cells and for radiation injury of bone marrow. Filgrastim is a human granulocyte colony-stimulating factor (G-CSF) which acts on hematopoietic cells by binding to specific cell surface receptors and regulating neutrophil production, progenitor proliferation, and differentiation. It also affects some end-cell functional activation including phagocytic activity, cellular metabolism, and antibodydependent killing. A recombinant, non-glycosylated cytokine which is chemically identical to or similar to the endogenous cytokine human G-CSF isoform B, with immunomodulating activity.
Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.
OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), as well as PIC/S and ANVISA requirements, and to obtain the following information:
To order an OEL/ADE monograph for Filgrastim, just click the ADD TO CART button.
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Not the compound you were looking for? You can search the OEL Fastrac catalog to find more available compounds.
Affygility Solutions’ OEL Fastrac service is an user-friendly system that enables us to make confident decisions and focus on moving the compound safely through our facility. We can quickly access the database to determine if a new drug is within the OEL Fastrac library, and if so, immediately download a detailed OEL banding report. The OEL Fastrac system has been a helpful tool in our overall EH&S program.