OEL Fastrac Catalog

 Please note, this OEL/ADE monograph also applies to sulfamethoxazole sodium (CAS RN 4563-84-2), Sulfamethoxazole monopotassium (CAS RN 124903-73-7), Sulfamethoxazole pamoate (CAS RN 100345-21-9), and Sulfamethoxazole chloride (CAS RN Not Available). Sulfamethoxazole is indicated in combination with trimethoprim, in various formulations, for the treatment of urinary tract infections (UTI) due to susceptible Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris, acute otitis media in pediatric patients due to susceptible Streptococcus pneumoniae and Haemophilus influenzae, acute exacerbations of chronic bronchitis in adults due to susceptible Streptococcus pneumoniae or Haemophilus influenzae, enteritis caused by susceptible Shigella flexneri, Shigella sonnei, and travelers’ diarrhea due to enterotoxigenic Escherichia coli (ETEC). Sulfamethoxazole has also been used in cases of nocardiosis, and in some other bacterial infections such as otitis media, Chlamydia and Chlamydophila infections, and for prophylaxis of meningococcal meningitis. Additionally, this monograph contains the pediatric ADE (pADE). Sulfamethoxazole is an intermediate-acting sulfonamide derivative indicated for the treatment of uncomplicated urinary tract infections and systemic infections caused by susceptible organisms. Sulfamethoxazole, a sulfonamide drug, inhibits bacterial synthesis of dihydrofolic acid by competing with para-aminobenzoic acid for binding to dihydrofolate synthetase, an intermediate of tetrahydrofolic acid (THF) synthesis. Inhibition of the THF synthesis inhibits bacterial growth.

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 Sulfamethoxazole, just click the ADD TO CART button.

HBEL

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