Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
GEMCITABINE
Generics (UK) Limited
1 Grams
Solution for Infusion
2009-08-28
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gemcitabine Mylan 1g powder for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g vial: each 50 ml vial contains 1000 mg of gemcitabine for reconstitution in 25 ml of solvent. Excipients Each 1 g vial contains 17.5 mg (<1 mmol) sodium. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for infusion. White to off-white plug or powder. 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 recommen Aqra d-dokument sħiħ