Botox Cosmetics Description

DESCRIPTION
BOTOX® Cosmetics (onabotulinumtoxinA) for injection, is a vacuum, dry sterile purified botulinum toxin type A, produced from fermentation of Hall strain Clostridium botulinum type A grown in medium containing casein hydrolyzate, glucose, and yeast extract, is intended to intramuscular use. 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 dissolved in a solution of sodium chloride containing sterile human albumin and sterile filtered (0.2 microns) prior to filling and vacuum drying.
One Unit of BOTOX® Cosmetics according to the median lethal intraperitoneal calculated Dose (LD 50
) In mice. The method used to perform testing that is specific to Allergan

BOTOX products® Cosmetics. Because specific details of these tests such as vehicles, dilution scheme and laboratory protocols for the various rat LD 50 tests, Units of biological activity BOTOX ® Cosmetics can not be compared with or converted into Units of any other botulinum toxin or any toxin assessed with any other special test methods. In addition, differences in species sensitivity to botulinum neurotoxin serotypes preclude extrapolation of different dose animal activity relationship of human dose estimates. Specific activity of BOTOX ® Cosmetics are about 20 units / nanograms of neurotoxin complex protein.
Each vial of BOTOX ® Cosmetics containing either 100 units of Clostridium botulinum type A neurotoxin complex, 0.5 mg Albumin Human, and 0.9 mg of sodium chloride or 50 Units Clostridium botulinum neurotoxin type A complex, 0.25 mg of human albumin, and 0.45 mg sodium chloride in a sterile, vacuum dried without preservative