Gemcitabine 100 mg/ml Concentrate for Solution for Infusion

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Gemcitabine

Boleh didapati daripada:

Accord Healthcare Limited

Kod ATC:

L01BC; L01BC05

INN (Nama Antarabangsa):

Gemcitabine

Dos:

100 Base mg/ml

Borang farmaseutikal:

Concentrate for solution for infusion

Jenis preskripsi:

Product subject to prescription which may not be renewed (A)

Kawasan terapeutik:

Pyrimidine analogues; gemcitabine

Status kebenaran:

Not marketed

Tarikh kebenaran:

2012-03-09

Ciri produk

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gemcitabine 100 mg/ml Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains Gemcitabine hydrochloride equivalent to 100 mg
gemcitabine.
Each vial of 2 ml concentrate for solution for infusion contains
Gemcitabine hydrochloride equivalent to 200 mg
gemcitabine.
Each vial of 10 ml concentrate for solution for infusion contains
Gemcitabine hydrochloride equivalent to 1000 mg
gemcitabine
Each vial of 15 ml concentrate for solution for infusion contains
Gemcitabine hydrochloride equivalent to 1500 mg
gemcitabine
Each vial of 20 ml concentrate for solution for infusion contains
Gemcitabine hydrochloride equivalent to 2000 mg
gemcitabine
Excipients with known effect:
9.192 mg/ml (0.4 mmol/ml) sodium.
440 mg/ml (44 % w/v) ethanol anhydrous
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear, colourless to slightly yellow solution. pH in the range of
approximately 6.0 to 7.5 and osmolarity in the range of
approximately 270 to 330 mOsmol/Litre after dilution with 0.9 % sodium
chloride solution at 0.1 mg/ml concentration.
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.
Ge