OEL Fastrac Catalog

Flumazenil is a potent benzodiazepine receptor antagonist indicated for the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or maintained with benzodiazepines. Flumazenil, an imidazobenzodiazepine derivative, competitively inhibits the benzodiazepine binding site on the GABA/benzodiazepine receptor complex. It is a weak partial agonist in some animal models but has little to no agonist activity in man. Flumazenil as a result antagonizes sedation, impairment of motor recall, psychomotor impairment, and ventilatory depression produced by benzodiazepines, but does not antagonize the central nervous system effects of drugs affecting GABAergic neurons by means other than the benzodiazepine receptor and does not reverse the effects of opioids.

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 Flumazenil, just click the ADD TO CART button.

HBEL

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