Pentetreotide is a diethylaminotriaminepentaacetic acid (DPTA) conjugate of octreotide, a long acting analog of somatostatin. It is used with Indium (In-111) as an imaging agent to visualize somatostatin receptor rich tissue. In combination with high activity In-111 it has been evaluated as a treatment for neuroendocrine tumors. Efficacy of pentetreotide is demonstrated by distribution of In-111 to somatostatin receptor rich tumors. The normal adult intravenous dose of pentetreotide used as the carrier agent in the diagnostic imaging test is 10 μg per use combined with 111 MBq of In-111. When used with high intensity In-111 to treat neuroendocrine tumors, the dose is 3-5 GBq In-111 combined with 30 μg pentetreotide per use.
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), and to obtain the following information:
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Affygility Solutions’s 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.