Please note, this OEL/ADE monograph also applies to levamisole hydrochloride (CAS RN 16595-80-5). Levamisole hydrochloride is the active laevo-isomer of tetramisole hydrochloride. Levamisole was commonly used as human antihelminthic and as an adjuvant in malignant disease (such as colorectal cancer therapy in conjunction with fluorouracil). It has also been tried in several conditions where its stimulant effect on the depressed immune response might be useful. Levamisole is used off-label as an adjuvant therapy in children with pediatric nephrotic syndrome, and it is registered as an orphan drug with the European Medicines Agency to treat steroid-sensitive nephrotic syndrome (SSNS). Because of serious side effects (agranulocytosis), it was withdrawn from United States (US) market. More recently, there are increasing health concerns related to its use as an adulterant in cocaine. At present, it is most commonly used as an antihelminth in veterinary medicine to treat parasitic infestation in animals, primarily in livestock (such as cattle, sheep, swine).
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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