Country: Jordan
Language: English
Source: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)
Gemcitabine 1000 mg/100ml
مستودع ادوية الصباغ - Sabbagh Drug Store
L01BC05
Gemcitabine 1000 mg/100ml
1000 mg/100ml
1 vial X 100ml
EBEWE Pharma (النمسا)
1. NAME OF THE MEDICINAL PRODUCT GEMCITABIN EBEWE 10 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 11.4 mg gemcitabine hydrochloride which corresponds to 10 mg of the active ingredient gemcitabine. Excipients included in the drug product that contain sodium are sodium acetate trihydrate and sodium hydroxide. Gemcitabin Ebewe 200 mg contains 21.49 mg (0.93 mmol), 500 mg contains 53.74 mg (2.34 mmol) and 1000 mg contains 107.47 mg (4.67 mmol) sodium per vial. For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. Product description: clear, colourless to pale yellow solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Gemcitabine is indicated for the treatment of locally advanced or metastatic bladder cancer in combination with cisplatin. Gemcitabine is indicated for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. Gemcitabine, in combination with cisplatin is indicated as first line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Gemcitabine monotherapy can be considered in elderly patients or those with performance status 2. Gemcitabine is indicated for the treatment of patients with locally advanced or metastatic epithelial ovarian carcinoma, in combination with carboplatin, in patients with relapsed disease following a recurrence-free interval of at least 6 months after platinum-based, first-line therapy. Gemcitabine, in combination with paclitaxel, is indicated for the treatment 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Gemcitabine should only be prescribed by a physician qualified in the use of anti-cancer chemotherapy. Recommended posology Bladder cancer Combination use The reco Read the complete document