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.本發明涉及用於腸胃外給藥的含水藥物組合物，其包含他噴他多或其生理上可接受的鹽，其中他噴他多的濃度為0.10 to 8.00mg/mL，基於他噴他多游離鹼的重量並基於所述組合物的總體積；並且其中所述組合物的pH值被緩衝並為4.0至6.0。本發明還涉及包含所述藥物組合物的容器和用於製備其的方法。本發明還涉及在包裝物中包含根據本發明的內容物的試劑套組。根據本發明的藥物組合物特別用於治療優選兒科患者中的疼痛，尤其是急性疼痛。
