OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to gentamicin sulfate (CAS RN 1405-41-0). Gentamicin is an aminoglycoside antibacterial used, often with other antibacterials, to treat severe systemic infections due to sensitive gram-negative and other organisms. Such infections include abscesses, biliary-tract infections (acute cholecystitis or cholangitis) , brucellosis, cat scratch disease, cystic fibrosis, endocarditis (in the treatment and prophylaxis of endocarditis due to streptococci, enterococci, or staphylococci), endometritis, gastroenteritis, granuloma inguinale, listeriosis, meningitis, otitis externa, otitis media, pelvic inflammatory disease, peritonitis, plague, pneumonia, septicemia, skin infections such as in burns or ulcers (given systemically for pseudomonal and other gram-negative infections), trench fever, tularemia, arid urinary tract infections (acute pyelonephritis) , as well as in the prophylaxis of surgical infection and the treatment of immunocompromised patients and those in intensive care. It may be used as part of a multidrug regimen for the treatment of inhalation and gastrointestinal (GI) anthrax. Gentamicin is also applied topically for localized infections.

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 Gentamicin, just click the ADD TO CART button.

HBEL

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