OEL Fastrac Catalog

Sirolimus, also known as rapamycin is an immunosuppressant indicated for prevention of organ rejection in patient receiving a kidney transplant and for treatment of lymphangioleiomyomatosis. Rapamycin is a macrolide compound obtained from Streptomyces hygroscopicus that selectively blocks cytokine production, antibody production, and inhibits T-lymphocyte activation and proliferation. It binds to the immunophilin, FK binding protein producing an immunosuppressive complex. The complex inhibits the activation of the mammalian target of rapamycin which suppresses cytokine-driven T-cell proliferation. Overall it suppresses the body’s immune system.

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 and the acceptable surface limit (ASL).

Why do you need this OEL Fastrac monograph?

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:

• The numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
• A listing of all cited references utilized in the derivation of the OEL and ADE
• An expert review and discussion with respect to the critical endpoints of concern, the rationale for the choice of endpoints, and dose that is to be used in the derivation of the ADE (PDE), as required by the EMA's Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Benefits of OEL Fastrac monographs

• Fully documented. Over 20 pages in length, with calculations and cited references.
• Save time! Unsurpassed delivery with instant download.
• Save money. Similar documents cost 5-12 times as much.
• Stay current. Automatic notification of revisions.

How to order

To order an OEL/ADE monograph for Sirolimus, just click the ADD TO CART button.

HBEL

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