Zomacton (Somatropin (rDNA origin) for Injection) | 合法醫療器材資訊網

ZOMACTON5mgand10mgcanbeadministeredusingastandardsteriledisposablesyringeoraZOMA-Jet®NeedleFreeDeliveryDevice,usingtherespectivedevice ...

Included as part of the "PRECAUTIONS" Section

Increased mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma[1], or those with acute respiratory failure has been reported after treatment with pharmacologic doses of somatropin [see CONTRAINDICATIONS[2]]. Two placebo-controlled clinical trials in non-GH deficient adult patients (n=522) with these conditions in intensive care units revealed a significant increase in mortality (42% vs. 19%) among somatropin-treated patients (doses 5.3 mg/day-8 mg/day) compared to those receiving placebo. The safety of continuing ZOMACTON treatment in patients receiving replacement doses for approved indications who concurrently develop these illnesses has not been establis...