GEMCITABINE MYLAN
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
GEMCITABINE
Available from:
Generics (UK) Limited
Dosage:
2 Grams
Pharmaceutical form:
Pdr for Soln for Infusion
Authorization date:
2010-03-31
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gemcitabine Mylan 2g, powder for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100 ml vial contains 2000 mg of gemcitabine for reconstitution in 50 ml of solvent.
1ml of reconstituted solution contains 38mg of gemcitabine
Excipients
Each 2000 mg vial contains 35mg (1.5 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 pos
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