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Overall, there was a statistically significant difference tapentadol morphine equivalent tapentadol adverse effects nucynta weight gain tapentadol vs between groups (p<0 . 001) in the time to treatment discontinuation due to AusPAR Palexia SR Tapentadol CSL Ltd PM-2009-02489-3-1 Final 28 February 2011 Page 94 of 126 Figure 13: Time to Onset of TEAEs Leading to Discontinuation (Study R331333-PAI3007/KF5503/24: Safety Analysis Set) Tapentadol ER= Tapentadol PR=Tapentadol SR Other safety aspects The incidence of adverse drug reactions related to the concept of tapentadol respiratory depression (aggregate preferred term of “respiratory depression”) for tapentadol SR was only reported in 2 of 3613 subjects (0 .
Primary attention should be given to reestablishment of a patent airway and institution of assisted or tapentadol controlled ventilation when overdose of PALEXIA® SR is suspected .
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