国家: 新西兰
语言: 英文
来源: Medsafe (Medicines Safety Authority)
Gemcitabine hydrochloride 227.7mg Equivalent to 200 mg gemcitabine base; ;
Pfizer New Zealand Limited
Gemcitabine hydrochloride 227.7 mg (Equivalent to 200 mg gemcitabine base)
200mg/vial
Powder for injection
Active: Gemcitabine hydrochloride 227.7mg Equivalent to 200 mg gemcitabine base Excipient: Hydrochloric acid Mannitol Sodium acetate trihydrate Sodium hydroxide
Vial, glass, 20mm clear Type 1 glass, 10 mL
Prescription
Prescription
Jiangsu Hansoh Pharmaceutical Co Ltd
Non-Small Cell Lung Cancer: gemcitabine, alone or in combination with cisplatin, is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer.
Package - Contents - Shelf Life: Vial, glass, 20mm clear Type 1 glass - 10 mL - 36 months from date of manufacture stored at or below 25°C 24 hours reconstituted (not refrigerated) stored at or below 25°C. +/- 5 degrees C, exposed to light when reconstitutes to 38 mg/mL with 0.9% NaCI
2007-07-25
Version: pfdgemsi10620 Supersedes:pfdgemsi10320 Page 1 of 24 NEW ZEALAND DATA SHEET 1. PRODUCT NAME _ _ DBL™ Gemcitabine Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Gemcitabine hydrochloride 43.3 mg/mL (equivalent to gemcitabine 38 mg/mL). Each vial contains gemcitabine hydrochloride. DBL Gemcitabine Injection contains no antimicrobial agent or preservatives. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for Injection DBL Gemcitabine Injection is a clear, colourless to light straw-coloured solution for intravenous use. Gemcitabine hydrochloride is a white to off-white powder. Gemcitabine is an acidic compound. The free base is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NON-SMALL CELL LUNG CANCER : gemcitabine, alone or in combination with cisplatin, is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer. PANCREATIC CANCER : gemcitabine is indicated for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. Gemcitabine is indicated for patients with 5- FU refractory pancreatic cancer. Patients treated with gemcitabine may derive improvement in survival, significant clinical benefit, or both. BLADDER CANCER : gemcitabine is indicated for the treatment of patients with bladder cancer. BREAST CANCER : gemcitabine, in combination with paclitaxel, is indicated for the first line treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy, containing anthracycline, unless clinically contraindicated. OVARIAN CANCER : gemcitabine, in combination with carboplatin, is indicated for the treatment of patients with recurrent epithelial ovarian carcinoma who have relapsed following platinum-based therapy. Version: pfdgemsi10620 Supersedes:pfdgemsi10320 Page 2 of 24 4.2 DOSE AND 阅读完整的文件