OEL Fastrac Catalog

DaxibotulinumtoxinA (also known as botulinum toxin A) is a neurotoxic protein produced by Clostridium botulinum. DaxibotulinumtoxinA is the active substance in preparations used for the highly effective treatment of neurologic disorders such as cervical dystonia, blepharospasm, or spasticity, as well as other indications such as axillary and palmar hyperhidrosis and urologic disorders. When consumed in contaminated food, the toxin can cause paralysis and death. Cosmetically, it is used for the treatment of facial fine lines and wrinkles, specifically for upper facial rhytids, including forehead, lateral canthus, and glabellar lines. In addition to the above indications, botulinum toxin A is used for the treatment of symptomatic overactive bladder in adults with or without incontinence, treatment of incontinence in adult patients who are not candidates for anticholinergic therapy, treatment of neurogenic detrusor overactivity (NDO) in patients over 5 years who cannot undergo anticholinergic therapy. Botulinum toxin A is indicated for the prevention of chronic migraines, for the treatment of muscle spasms, cervical dystonia, axillary hyperhidrosis, strabismus, and disorders of the 7th cranial nerve, temporomandibular joint (TMJ) disorders and myofascial pain, neurogenic thoracic outlet syndrome, epicondylitis, poststroke pain, postherpetic neuralgia, diabetic neuropathy, trigeminal neuralgia, neuropathic pain, spinal cord injury, and bladder pain.

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 DaxibotulinumtoxinA, just click the ADD TO CART button.

HBEL

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