Gemcitabine Injection, Powder, Lyophilized, For Solution
Product Images NDC 71288-113

This is a description of the results obtained from a clinical trial that compared the efficacy of Gemcitabine for Injection/Paclitaxel to Paclitaxel alone in terms of progression-free survival time (length of time during which the disease doesn't worsen) for patients with an unspecified type of illness. The study involved 267 patients who received Gemcitabine for Injection/Paclitaxel and 262 patients who received Paclitaxel only. The results show that patients who received Gemcitabine for Injection/Paclitaxel had a significantly longer progression-free survival time (5.2 months) compared to those who received Paclitaxel only (2.8 months) with a p-value of <0.0001. The data is presented graphically as a survival curve with the time to documented disease progression measured in months on the horizontal axis and the proportion of patients without progression on the vertical axis.*

This seems to be a table from a medical study that compares the effectiveness of Gemeltabine or injection in regards to the fraction of patients who survived a certain amount of time after treatment. The table shows the fraction of patients surviving at different durations ranging from 0 to 16 months. However, since there is no clear indication of the actual percentages and values associated with each treatment, it's difficult to determine the efficacy of each treatment.*

Gemcitabine Hydrochloride is a sterile, nonpyrogenic, and preservative-free injection contained in a single-dose vial. The usual adult dose is specified in the accompanying literature. The solution must be reconstituted by adding 5 mL of 0.9% Sodium Chloride Injection to make a solution containing 38 mg/mL. The intravenous solution must be prepared by a healthcare professional and administered within 24 hours. Gemcitabine Hydrochloride is not to be refrigerated and the unused portion must be discarded. The container closure is free from natural rubber latex.*

This is a description of Gemcitabine HCI USP, a sterile, nonpyrogenic, and preservative-free medicine that is used for injection. The container closure is not made with natural rubber latex, and each vial contains gemcitabine HCI USP, equivalent to 1 g of gemcitabine, 1 g of mannitol, and 103.5 mg of sodium. This medicine is a cytotoxic agent that must be administered intravenously within 24 hours after reconstitution. To prepare the intravenous solution, 25 mL of 0.9% sodium chloride injection (without preservatives) must be added to each vial that has been stored at room temperature, and it must be further diluted before use.*