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Botulinum Toxin Type ABEAUTEOUSPosted Date: March 29, 2005
Specifications:
(Botulinum Toxin Type A) Purified Neurotoxin Complex is a sterile, vacuum-dried purified botulinum toxin type A, produced from fermentation of Hall strain Clostridium botulinum type A grown in a medium containing casein hydrolysate, glucose and yeast extract. It is purified from the culture solution by dialysis and a series of acid precipitations to a complex consisting of the neurotoxin, and several accessory proteins. The complex is dissolved in sterile sodium chloride solution containing albumin human and is sterile filtered (0.2 microns) prior to filling and vacuum-drying.
One unit (U) of beauteous equal one unit (U) of Botox(Allergan). The method utilized for performing the assay is specific to laboratory's data. Due to specific details of this assay such as the vehicle, dilution scheme and laboratory protocols for the various mouse LD50 assays, Units of biological activity of BOTOX A cannot be compared to nor converted into Units of any other botulinum toxin or any toxin assessed with any other specific assay method. Therefore, differences in species sensitivities to different botulinum neurotoxin serotypes precludes extrapolation of animal-dose activity relationships to human dose estimates. The specific activity of beauteous is approximately 20 units/nanogram of neurotoxin protein complex.
Pharmacokinetics
Botulinum Toxin Type A is not expected to be present in the peripheral blood at measurable levels following IM injection at the recommended doses. The recommended quantities of neurotoxin administered at each treatment session are not expected to result in systemic, overt distant clinical effects, I. E. Muscle weakness, in patients without other neuromuscular dysfunction. However, sub-clinical systemic effects have been shown by single-fiber electromyography after IM doses of botulinum toxins appropriate to produce clinically observable local muscle weakness. These side effects may be due to local spread of toxin from the injection site and/or misplaced injections.
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Mr. Mr. mark king ()
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