Powder lyophilized for preparing solution
for injection 200 mg, 1000 mg
Trade name: Gemcitabine.
International nonproprietary name: Gemcitabine.
Composition: each 10 ml vial contains:
Active substance: gemcitabine (as gemcitabine hydrochloride) – 200 mg and 1000 mg.
Excipients: mannitol, sodium acetate (as sodium acetate trihydrate).
Dosage form: lyophilized powder for solution for infusion.
ATC code: L01BC05
Indications for use:
► Treatment of localized or metastatic bladder cancer in combination with cisplatin.
► Treatment of localised or metastatic pancreatic adenocarcinoma.
► First – line therapy of localised or metastatic non- small cell lung cancer (NSCLC) in combination with cisplatin. Gemcitabine monotherapy is possible in elderly patients or patients with physical function 2.
► Treatment of localised or metastatic epithelial ovarian cancer in combination with carboplatin in relapse patients after at least 6 months of delaying time to relapse after the end of the first line of platinum- based therapy.
► Complex treatment with paclitaxel of localised unresectable or metastatic breast cancer in relapse patients after adjuvant/non- adjuvant chemotherapy.
The primary therapy shall include anthracycline in absence of contraindications.
