国家: 澳大利亚
语言: 英文
来源: Department of Health (Therapeutic Goods Administration)
gemcitabine hydrochloride, Quantity: 1.14 g (Equivalent: gemcitabine, Qty 1 g)
Medis Pharma Pty Ltd
Gemcitabine hydrochloride
Injection, powder for
Excipient Ingredients: mannitol; sodium hydroxide; sodium acetate trihydrate
Intravenous Infusion
1 x 50 mL vial
(S4) Prescription Only Medicine
Treatment of patients with locally advanced or metastatic non-small cell lung cancer. Treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. Treatment of patients with FU refractory pancreatic cancer. Treatment of patients with bladder cancer, alone or in combination with cisplatin. Treatment, in combination with paclitaxel, of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/ neoadjuvant chemotherapy. Prior chemotherapy should have included an anthracycline unless clinically contraindicated. Treatment, in combination with carboplatin, of patients with recurrent epithelial ovarian carcinoma, who have relapsed >six months following platinum based therapy.
Visual Identification: White or almost white lyophilisate; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2010-06-07
CONSUMER MEDICINE INFORM ATION GEMPLAN 阅读完整的文件
PRODUCT INFORMATION NAME OF THE MEDICINE GEMPLAN gemcitabine (as hydrochloride) 200mg powder for injection gemcitabine (as hydrochloride) 1000mg powder for injection NON-PROPRIETARY NAME: Gemcitabine Hydrochloride sustained worsening in any of the parameters. Sustained worsening was defined as four consecutive weeks with either an increase in pain intensity or analgesic consumption or a 20 point decrease in performance status occurring during the first 12 weeks of therapy. Or 2. The patient was stable on all aforementioned parameters and showed a marked sustained weight gain (greater than or equal to 7% increase maintained for greater than or equal to four weeks), not due to fluid accumulation. The first study was a multicentre, prospective, single blinded, two arm, randomised comparison of gemcitabine and FU in patients with locally advanced or metastatic pancreatic cancer who had received no prior treatment with chemotherapy. FU was administered intravenously at a weekly dose of 600 mg/m 2 for 30 minutes. The results for this randomised trial are shown in TABLE 1. Compared to FU, patients treated with gemcitabine had statistically significant increases in symptomatic improvement, survival and time to progressive disease (23.8% versus 4.8%). TABLE 1 Summary of Gemcitabine vs FU in pancreatic cancer Gemcitabine FU Number of patients 63 63 Total: 126 Stage IV disease 71.4% 76.2% Baseline KPS ≤ 70 69.8% 68.3% Clinical response 1 23.8% (N=15) 4.8% (N=3) p=0.0022 Survival p=0.0009 Median 5.7 months 4.2 months 6 month probability 46% (N=30) 29%(N=19) 9 month probability 24%(N=14) 5%(N=4) 1 year probability 18%(N=9) 2%(N=2) Range 0.2 to 18.6 months 0.4 to 15.1 + months Time to progressive disease p=0.0013 Median 2.1 months 0.9 months Range 0.1 + to 9.4 months 0.1 to 12.0 + months 1 As per previous definition, + =no progression of disease at last visit, still alive The second trial was a multicentre, open label study of 63 patients with advanced pancreatic cancer previously treated with FU or a FU containing regimen. 阅读完整的文件