GEMZAR 200 MG POWDER 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:
GEMCITABINE HYDROCHLORIDE
Available from:
Eli Lilly and Company Limited
Dosage:
200 mg Milligram
Pharmaceutical form:
Pdr for Soln for Infusion
Authorization date:
1998-10-16
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gemzar 200mg Powder for Solution for Infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains gemcitabine hydrochloride equivalent to 200mg gemcitabine.
After reconstitution, the solution contains 38 mg/ml of gemcitabine.
Excipients:
Each 200mg vial contains 3.5 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 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.
IRISH MEDICINES BOARD
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_Date Printed 23/08/2011_
_CRN 2104628_
_page number:
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