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Tapentadol tapentadol glucuronidation was catalysed primarily by human UGT1A6, UGT1A9 and UGT2B7 in vitro and human CYP450 enzymes involved in tapentadol metabolism in vitro include CYP2B6, CYP2C8, CYP2C9, CYP2C19 and CYP2D6 .
c Monkeys were administered 15 mg/day; dose was adjusted for tapentadol 3 kg body weight .
The effect of concomitant food intake on the pharmacokinetics of tapentadol is tapentadol considered to be of no clinical significance .
No further risk minimisation activities are identified as tapentadol necessary or requested to date .
AusPAR Palexia SR Tapentadol CSL Ltd tapentadol PM-2009-02489-3-1 Final 28 February 2011 Page 98 of 126 A summary of the Risk Managment Plan is presented in Table 40 below .
Demographic and baseline characteristics There were 981 tapentadol subjects randomised .
This graph indicates that the dosage regimen simulated was 100 mg tapentadol IR, every 4 h tapentadol france tapentadol umrechnung morphin tapentadol metabolites nucynta respiratory (that is, 600 mg/day) and not the maximum recommended starting dose of 700 mg/day (100 mg every 4 h, plus an extra 100 mg 1 h after the first dose) .
Overall Conclusion and Risk/Benefit Assessment The submission was summarised in the following Delegate’s overview and nucynta like percocet nucynta narcotic tapentadol respiratory depression tapentadol vs oxycodone recommendations: AusPAR Palexia SR Tapentadol CSL Ltd PM-2009-02489-3-1 Final 28 February 2011 Page 99 of 126 There are no objections in respect of Chemistry, Manufacturing and Controls to registration of tapentadol SR tablets, however the retest period applied to the API should be restricted to 30 months rather than the 36 months proposed by the company .
It is questionable whether the dosage levels in the mouse study were adequate, as there was limited evidence of toxicity (including negligible effects on body weight gain) and AUC-based exposure margins were low tapentadol (≤ 0 .

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