Hyaluronidase is an enzyme used to improve the absorption and dispersion of parenterally administered fluids, drugs, and contrast agents. Hyaluronidase can be used to enhance permeation of subcutaneous or intramuscular injections, local anesthetics, and subcutaneous infusions and to promote resorption of excess fluids and blood in the tissues. Hyaluronidase (human recombinant) is produced by genetically engineered Chinese hamster ovary (CHO) cells containing a deoxyribonucleic acid (DNA) plasmid encoding for a soluble fragment of human hyaluronidase (PH20). Hyaluronidase has been used in surgical settings for at least the past 60 years to improve the diffusion of local anesthetics. Hyaluronidase is indicated for subcutaneous (SC) fluid administration for hydration and increasing resorption of radiopaque agents in SC urography. Hyaluronidase is also indicated by multiple routes to increase the dispersion of other injectable drugs.
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:
To order an OEL/ADE monograph for Hyaluronidase (Human Recombinant), just click the ADD TO CART button.
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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.