OEL Fastrac Catalog

Silver norfloxacin (CAS RN 88056-28-4), Norfloxacin hydrochloride (CAS RN 68077-27-0), and norfloxacin pivoxil. Additionally, this monograph contains the pediatric ADE (pADE). Norfloxacin is a quinolone/fluoroquinolone carboxylic acid antibacterial agent. Norfloxacin is indicated in the treatment of upper and lower urinary tract infections, specifically complicated and uncomplicated cystitis, pyelitis and pyelonephritis caused by susceptible strains of the following microorganisms - Escherichia coli, Klebsiella pneumonia (unspecified Klebsiella spp., unspecified Enterobacter spp., unspecified Citrobacter spp.), Proteus mirabilis, Staphylococcus aureus, Streptococcus faecalis and Pseudomonas aeruginosa. It is also used in the treatment of adults with gonococcal urethritis, or cervicitis due to penicillinase producing and non-penicillinase producing Neisseria gonorrhoeae.

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 Norfloxacin, just click the ADD TO CART button.

HBEL

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