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Pharmacotherapeutic classification: Antidote.
Pharmacology: Toxicology: Preclinical safety data: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction and development.
High dose treatment in pregnant rats and rabbits revealed no evidence of impaired female fertility or harm to the foetus due to acetylcysteine.
Treatment of male rats for 16 weeks with acetylcysteine at an oral dose considered sufficiently in excess compared to the recommended human dose did not affect the fertility or general reproductive performance of the animals.
