Reproductive and developmental studies in animals demonstrated that diclofenac sodium administration during organogenesis did not produce teratogenicity despite the induction of maternal toxicity and fetal toxicity in mice at oral doses up to 20 mg kg day approximately 5 times the maximum recommended human dose mrhd of voltaren gel based on bioavailability and body surface area bsa comparison , and in rats and rabbits at oral doses up to 10 mg kg day approximately 5 and 10 times the mrhd based on bioavailability and bsa comparison .
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