GEMCITABINE MYLAN
Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Vara einkenni
(SPC)
06-05-2024
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Virkt innihaldsefni:
GEMCITABINE
Fáanlegur frá:
Generics (UK) Limited
Skammtar:
1 Grams
Lyfjaform:
Solution for Infusion
Leyfisdagur:
2009-08-28
Vara einkenni
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gemcitabine Mylan 1g powder for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g vial: each 50 ml vial contains 1000 mg of gemcitabine for reconstitution in 25 ml of solvent.
Excipients
Each 1 g vial contains 17.5 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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Gemcitabine should only be prescribed by a physician qualified in the use of anti-cancer chemotherapy.
Recommended posology
_Bladder cancer_
_Combination use_
The recommen
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