SCHILLER, MARC,VAN HEMELRIJCK, CARLOS,STRAUB, STEFANIE,WULSTEN, EVA CORNELIA,BERTRAM, ULRIKE,REINHOLD, ULRICH
申请号:
CA2979034
公开号:
CA2979034A1
申请日:
2016.03.23
申请国别(地区):
CA
年份:
2016
代理人:
摘要:
The invention relates to an aqueous pharmaceutical composition for parenteral administration comprising Tapentadol or a physiologically acceptable salt thereof, wherein the concentration of Tapentadol is within the range of from 0.10 to 8.00mg/mL, based on the weight of Tapentadol free base and based on the total volume of the composition; and wherein the pH value of the composition is buffered and within the range of from 4.0 to 6Ø The invention also relates to a container comprising the pharmaceutical composition and a process for the preparation thereof. The invention also relates to a kit comprising the contained according to the invention in a packaging. The pharmaceutical composition according to the invention is particularly useful for treating pain, especially acute pain, preferably in pediatric patients.