GEMCITABINE Pdr for Soln for Infusion 1 Grams
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-03-2023
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Active ingredient:
GEMCITABINE
Available from:
HOSPIRA UK Ltd
Dosage:
1 Grams
Pharmaceutical form:
Pdr for Soln for Infusion
Authorization date:
2007-11-09
Summary of Product characteristics
License
Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Gemcitabine 1 g Powder for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains gemcitabine hydrochloride, equivalent to 1 g gemcitabine.
After reconstitution, the solution contains 38 mg/ml gemcitabine (as hydrochloride).
Excipients
Each 1 g vial contains approximately 17.5 mg (0.75 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.
Bre
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