GEMCITABIN EBEWE
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Package(a):
VIAL: 1 x 10 ml x 200 mg (after reconstitution the solution contains 38 mg/ml gemcitabine).
Dosage(a):
IV use. The dosage is according to physician's instructions, and has to be adjusted according to the indication, general condition, hepatic and renal function and concurrent chemotherapy and blood counts.
Prescribing Restrictions:
Package(b):
VIAL: 1 x 50 ml x 1,000 mg (after reconstitution the solution contains 38 mg/ml gemcitabine).
Dosage(b):
IV use. The dosage is according to physician's instructions, and has to be adjusted according to the indication, general condition, hepatic and renal function and concurrent chemotherapy and blood counts.
Prescribing Restrictions:
Package(c):
VIAL (concentrate for solution for infusion): 1 x 200 mg x 40 mg/ml.
Dosage(c):
IV use. The dosage is according to physician's instructions, and has to be adjusted according to the indication, general condition, hepatic and renal function and concurrent chemotherapy and blood counts.
Prescribing Restrictions: None
Package(d):
VIAL (concentrate for solution for infusion): 1 x 1,000 mg x 40 mg/ml.
Dosage(d):
IV use. The dosage is according to physician's instructions, and has to be adjusted according to the indication, general condition, hepatic and renal function and concurrent chemotherapy and blood counts.
Prescribing Restrictions: None
Package(e):
VIAL (concentrate for solution for infusion): 1 x 2,000 mg x 40 mg/ml.
Dosage(e):
IV use. The dosage is according to physician''s instructions, and has to be adjusted according to the indication, general condition, hepatic and renal function and concurrent chemotherapy and blood counts.
Prescribing Restrictions: None
Indications:
Palliative treatment of patients with locally advanced or metastatic non-small cell lung cancer and locally advanced or metastatic adenocarcinoma of the pancreas and for patients with 5-FU refractory pancreatic cancer.
Treatment of patients with bladder cancer at the invasive stage.
In combination with paclitaxel 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.
In combination with carboplatin for the treatment of patients with recurrent epithelial ovarian carcinoma that has relapsed at least six months after platinum based therapy.
Contra-Indications:
Hypersensitivity to gemcitabine, or to any of the constituents. Pregnancy, lactation. See prescribing information for full details.
Special Precautions:
See prescribing information for full details.
Side Effects:
Nausea with or without vomiting, raised AST/ALT and alkaline phosphotases. Proteinuria and hematuria, dyspnea, allergic skin rashes. See prescribing information for full details.
Drug Interactions:
See prescribing information for full details.
