OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to mometasone furoate (CAS RN 83919-23-7) and mometasone furoate monohydrate (CAS RN 141646-00-6). Mometasone is a synthetic topical glucocorticoid receptor (GR) agonist with antiinflammatory, antipruritic, and vasoconstrictive properties The furoate ester form (nasal spray formulation) is indicated in adults, adolescents, and children between the ages of 3 and 11 years to treat the symptoms of seasonal or perennial allergic rhinitis. In adults and children 12 years of age and older, it is indicated as adjunctive treatment to antibiotics in acute episodes of rhinosinusitis, where signs or symptoms of bacterial infection are present. Furthermore, it is used in adults and children 12 years of age and older in the treatment of symptoms associated with mild to moderate uncomplicated acute rhinosinusitis, where signs or symptoms of bacterial infection are not present. Additionally, it is indicated in the treatment of nasal polyps in adult patients 18 years of age or older.

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 Mometasone, just click the ADD TO CART button.

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