OEL Fastrac Catalog

This monograph contains both the OEL and ADE. Colchicine is an anti-gout preparation. Colchicine is used for acute gout attacks to reduce pain and inflammation. It may be used on long-term basis to prevent or reduce the frequency of attacks. Colchicine is used on long-term basis to prevent fever and recurrent inflammation of membranes. Colchicine is effective in preventing the inflammation of tissues around the heart. olchicine has been showed to be effective in the treatment of blood vessel, skin and mucosal inflammation symptoms. Colchicine has been used in the treatment of autoimmune-based thickening of the skin and lymph node enlargement due to inflammatory cell accumulation. Colchicine is highly potent and will require validated engineering controls in order to control occupational exposures down to an acceptable airborne concentration. To order this occupational exposure limit monograph for immediate download, click on the order now button to the right.

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 Colchicine, just click the ADD TO CART button.

HBEL

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