GEMCITABINE EBEWE 10 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
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Active ingredient:
GEMCITABIN HCL GEMCITABIN HCL GEMCITABIN HCL
Available from:
Ebewe Pharma Ges.m.b.H Nfg. KG
Dosage:
10
Pharmaceutical form:
Concentrate for Soln for Inf
Authorization date:
2010-04-23
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gemcitabine 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.
Each vial contains 10 mg/ml gemcitabine (as hydrochloride).
Each 20 ml vial contains 200 mg gemcitabine (as hydrochloride).
Each 50 ml vial contains 500 mg gemcitabine (as hydrochloride).
Each 100 ml vial contains 1000 mg gemcitabine (as hydrochloride).
Excipients: sodium (as sodium acetate trihydrate and sodium hydroxide) 1.07 mg/ml (0.05 mmol).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion
Product description: clear, colourless or almost colourless solution.
pH: 5.0 – 6.0
Osmolarity: 121,7 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
recurr
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