Name and Description of Investigational Medicinal Product Sample Clauses

Name and Description of Investigational Medicinal Product. BTX-A is a potent neurotoxin isolated from the bacterium Clostridium botulinum, a gram- positive, spore-forming anaerobe. BTX-A, a single chain protein with a molecular weight of approximately 150000 Daltons (Da), is one of seven different serotypes (classed A through G) of botulinum toxin (BTX) produced by this organism. Proteins endogenous to the bacterium cleave the single chain protein, resulting in a di-chain neurotoxin containing a light chain (molecular weight of approximately 50000 Da) and a heavy chain (molecular weight ca. 100000 Da) that remain linked by inter-chain disulfide and noncovalent bonds. Dysport® is a freeze dried preparation of Clostridium BTX-A-haemagglutinin complex (BTX- A-HAC) formulated with lactose (bulking agent) and human serum albumin. A more detailed description of the product is provided in Section 6.1.1 and Section 6.1.2. Further details can also be found in the Dysport® IB.
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