OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to Foscarnet trisodium (CAS RN 63585-09-1) and Foscarnet trisodium hexahydrate (CAS RN 34156-56-4). Foscarnet sodium is an antiviral agent indicated for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS), as a combination therapy with ganciclovir for patients who have relapsed after monotherapy with either drug, and for the treatment of acyclovir-resistant mucocutaneous herpes simplex virus (HSV) infections in immunocompromised patients. It is also prescribed outside of the United States for treatment of varicella-zoster infections in patients with AIDS, prophylaxis or preemptive treatment of CMV disease in allogeneic or autologous hematopoietic stem cell transplant (HSCT) recipients, as well as long-term suppressive and maintenance therapy and prophylaxis of CMV and HSV infections in HIV infected patients with frequent or severe recurrences.

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.

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 Foscarnet, just click the ADD TO CART button.

HBEL

If you're wondering about HBEL, we have something for you.