Fluvastatin sodium is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to 1) reduce elevated total cholesterol, low density lipoprotein-C (LDL-C), Apo B, and triglycerides (TG) and to increase high density lipoprotein-C in adult patients, 2) reduce elevated TC, LDL-C, and Apo B levels in boys and post-menarchal girls with genetic hypercholesterolemia, 3) reduce the risk of undergoing revascularization procedures caused by coronary heart disease (CHD) and 4) slow the progression of atherosclerosis in patients with CHD.
Please note, this OEL/ADE monograph also applies to Fluvastatin (CAS RN 93957-54-1).
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), and to obtain the following information:
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Affygility Solutions’s 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.