SCHILLER, Marc,VAN HEMELRIJCK, Carlos,STRAUB, Stefanie,WULSTEN, Eva Cornelia,BERTRAM, Ulrike,Reinhold, Ulrich
申请号：
HUE16714327
公开号：
HUE042612T2
申请日:
2016.03.23
申请国别(地区):
HU
年份:
2019
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 8.00 mg/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 6.0. 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.
