OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to Epinephrine hydrochloride (CAS RN 55-31-2) and Epinephrine bitartrate (CAS RN 51-42-3). Epinephrine, also known as adrenaline, is a hormone and neurotransmitter produced by the adrenal glands that can also be used as a drug due to its various important functions. Epinephrine injection is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (such as those in the order Hymenoptera, which includes bees, wasps, hornets, yellow jackets and fire ants) and biting insects (such as Triatoma species or mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (such as radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Injectable epinephrine is intended for immediate/urgent administration in patients who are found to be at increased risk for anaphylaxis, including individuals with a history of anaphylaxis.

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 Epinephrine, just click the ADD TO CART button.

HBEL

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