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Pharmacology: Toxicology: Carcinogenesis, Mutagenesis, Impairment of Fertility: Long term studies in animals have not been performed to evaluate carcinogenic potential.
Animal Toxicity: In a study of other botulinum toxin product to evaluate inadvertent peribladder administration, bladder stones were observed in one among four male monkeys that were injected with a total of 6.8 U/kg divided into the prostatic urethra and proximal rectum (single administration). No bladder stones were observed in male or female monkeys following injection of up to 36 U/kg (~12X the human dose) directly to the bladder as either single or four times repeat dose injections or in female rats for single injection of up to 100 U/kg (~33X the human dose).
