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Effects on female fertility, embryofetal development/ teratogenicity and postnatal survival were observed, mostly associated with nucynta maternotoxicity .
nucynta Consistent with other opioids, tapentadol exhibited dependence potential, withdrawal effects and tolerance development in animals .
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Tapentadol dose levels were limited in all nonclinical species due to excessive toxicity(particularly CNS) and resulting animal/human systemic exposure margins were quite low, thereby limiting the ability of the nonclinical studies to assess tapentadol trade name tapentadol dolor neuropatico tapentadol and pregabalin palexia ir tapentadol the safety of tapentadol .
The nucynta above toxicity concerns have been identified and described in the safety specification in the Risk Management Plan .
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Clinical nucynta Findings Clinical Development Programme This submission included full reports from 27 completed clinical studies of tapentadol SR (17 Phase I and 10 Phase II/III studies) .
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