Please note, this OEL/ADE monograph also applies to dinoprostone tromethamine (CAS RN 54831-69-5), dinoprost (CAS RN 551-11-1), and dinoprost tromethamine (CAS RN 38562-01-5). Dinoprostone is a naturally occurring prostaglandin E2 (PGE2). It has important effects in labor. It also stimulates osteoblasts to release factors which stimulate bone resorption by osteoclasts. Dinoprostone is indicated for the termination of pregnancy during the second trimester (from week 12 through week 20 of gestation as calculated from the first day of the last normal menstrual period), as well as for evacuation of the uterine contents in the management of missed abortion or intrauterine fetal death up to 28 weeks of gestational age as calculated from the first day of the last normal menstrual period. Dinoprostone is also used in the management of nonmetastatic gestational trophoblastic disease (benign hydatidiform mole). Other indications include improving the cervical inducibility (cervical "ripening") in pregnant women at or near term with a medical or obstetrical need for labor induction, and for the management of postpartum hemorrhage.
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.
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:
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Affygility Solutions’ OEL Fastrac service is an user-friendly system that enables us to make confident decisions and focus on moving the compound safely through our facility. We can quickly access the database to determine if a new drug is within the OEL Fastrac library, and if so, immediately download a detailed OEL banding report. The OEL Fastrac system has been a helpful tool in our overall EH&S program.