Package(a):
VIAL (concentrate for solution for infusion): 1 x 10 ml. Dosage(a):
IV infusion administration. For adults only.
The recommended dose in adjuvant setting is 85 mg/m2 repeated every 2 weeks for 12 cycles (6 months).
Treatment of metastatic colorectal cancer: 85 mg/m2 repeated every 2 weeks.
To be administered as a 2-6 hour IV infusion in 5% glucose solution. See literature.
Mainly used in combination with continuous infusion 5-fluorouracil (5-FU) based regimens.
Renal impairment: In moderate renal impairment, treatment may be initiated at the normally recommended dose. There is no need for dose adjustment in patients with mild renal dysfunction. Has not been studied in patients with severe renal impairment.
Hepatic impairment: During clinical development no specific dose adjustments for patients with abnormal liver function were performed.
Elderly patients: No specific dose adjustments are required for the elderly.
Should always be administered before fluoropyrimidines.
See literature. Prescribing Restrictions: None
Package(b):
VIAL (concentrate for solution for infusion): 1 x 20 ml. Dosage(b):
IV infusion administration. For adults only.
The recommended dose in adjuvant setting is 85 mg/m2 repeated every 2 weeks for 12 cycles (6 months).
Treatment of metastatic colorectal cancer: 85 mg/m2 repeated every 2 weeks.
To be administered as a 2-6 hour IV infusion in 5% glucose solution. See literature.
Mainly used in combination with continuous infusion 5-fluorouracil (5-FU) based regimens.
Renal impairment: In moderate renal impairment, treatment may be initiated at the normally recommended dose. There is no need for dose adjustment in patients with mild renal dysfunction. Has not been studied in patients with severe renal impairment.
Hepatic impairment: During clinical development no specific dose adjustments for patients with abnormal liver function were performed.
Elderly patients: No specific dose adjustments are required for the elderly.
Should always be administered before fluoropyrimidines.
See literature. Prescribing Restrictions: None
Indications:
In combination with 5-fluorouracil (5-FU) and folinic acid (FA) for: Adjuvant treatment of stage III (Duke's C) colon cancer after complete resection of primary tumor; treatment of metastatic colorectal cancer. Contra-Indications:
Hypersensitivity to oxaliplatin or to any of the excipients. Lactation. Patients with a peripheral sensitive neuropathy with functional impairment prior to first course. Myelosuppression prior to starting first course, as evidenced by baseline neutrophils <2 x 109/l and/or platelet count of <100 x 109/l. Patients with severely impaired renal function (creatinine clearance less than 30 ml/min). Special Precautions:
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