GEMCITABINE Pdr for Soln for Infusion 200 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
GEMCITABINE
Available from:
HOSPIRA UK Ltd
Dosage:
200 Milligram
Pharmaceutical form:
Pdr for Soln for Infusion
Authorization date:
2007-11-09
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gemcitabine 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 gemcitabine (as hydrochloride).
Excipients
Each 200 mg vial contains approximately 3.5 mg (0.15 mmol) sodium.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for infusion (powder for infusion)
White to off-white
plug or powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
BLADDER CANCER:
Locally advanced or metastatic bladder cancer, in combination with cisplatin.
PANCREATIC CANCER:
Locally advanced or metastatic adenocarcinoma of the pancreas.
NON-SMALL CELL LUNG CANCER:
First-line treatment of patients with locally advanced or metastatic non-small cell lung cancer, in combination with
cisplatin. Gemcitabine monotherapy can be considered in elderly patients or those with performance status 2.
OVARIAN CANCER:
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.
BREAST CANCER:
Unresectable, locally recurrent or metastatic breast cancer, in combination with paclitaxel, in patients experiencing a
relapse after adjuvant/neoadjuvant chemotherapy. The preceding chemotherapy should have included an anthracycline,
unless clinically contraindicated.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For intravenous infusion, following reconstitution. Upon reconstitution a colourless or slightly yellow solution is
produced.
GEMCITABINE SHOULD ONLY BE PRESCRIBED BY A PHYSICIAN QUALIFIED IN THE USE OF ANTI-CANCER CHEMOT
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