OEL Fastrac Catalog

Suboxone is administered as a sublingual tablet containing buprenorphine hydrochloride and naloxone hydrochloride in the treatment of opioid dependency. Buprenorphine hydrochloride is a partial mu-opioid receptor agonist and a kappa-opiod receptor antagonist. Naloxone hydrochloride is a mu-opioid receptor antagonist and antagonizes the analgesic, psychotogenic, dysphoric, miotic and other pharmacologic effects of opioid analgesics.

Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API).

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.

Inquiries on monograph availability

The OEL monograph for Suboxone is under development.

You can contact us and let us know if you'd like to be notified when this document becomes available.

HBEL

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