Please note, this OEL/ADE monograph also applies to cabotegravir sodium (CAS RN 1051375-13-3). Cabotegravir, as cabotegravir and cabotegravir sodium, is a human immunodeficiency virus (HIV) integrase inhibitor that is approved in Canada for the treatment of HIV type 1. Cabotegravir sodium, in tablet form, is indicated in combination with rilpivirine tablets, as a complete regimen for short-term treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically stable and suppressed (HIV-1 RNA less than 50 copies/mL). It is also indicated as an oral lead-in to assess tolerability of cabotegravir, or as an oral bridging therapy for missed injections of cabotegravir and rilpivirine extended-release injectable suspensions.
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 Cabotegravir, just click the ADD TO CART button.
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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.