Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
GEMCITABINE
Ebewe Pharma Ges.m.b.H Nfg. KG
200 Milligram
Pdr for Soln for Infusion
2009-04-03
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gemcitabine Ebewe 200 mg powder for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains gemcitabine hydrochloride equivalent to 200 mg gemcitabine. After reconstitution, the solution contains 38 mg/ml of gemcitabine. Excipients Each 200 mg vial contains 3.9 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 cake 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. IRISH MEDICINES B Read the complete document