Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
GEMCITABINE HYDROCHLORIDE
Ebewe Pharma Ges.m.b.H Nfg. KG
40 Mg/Ml
Concentrate for Soln for Inf
2011-01-21
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gemcitabine Ebewe 40 mg/ml concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 45.6 mg gemcitabine hydrochloride which corresponds to 40 mg of the active ingredient gemcitabine. Each 5 ml vial contains 200 mg gemcitabine (as hydrochloride). Each 25 ml vial contains 1000 mg gemcitabine (as hydrochloride). Each 50 ml vial contains 2000 mg gemcitabine (as hydrochloride). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion Clear, colourless or almost colourless solution. pH: 2.0 – 2.8 Osmolarity: 270 – 280 mOsmol/kg 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 c Read the complete document