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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
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