Oxaliplatin 50mg / 10ml injection
Ferron Par Pharmaceuticals
Ingredients in every 10 ml
| Oxaliplatin | 50 mg |
Each package contains
1 vial of 10 ml
Dosage form
 |
injection |
Dosage formInjection
Flavour
None
W.H.O. classification
L01X
L01X
A.T.C. Level 1
Anatomical Main group
L - Antineoplastic and immunomodulating agents
L01X
A.T.C. Level 2
Therapeutic subgroup
L01 - Antineoplastic Agents
L01X
A.T.C. Level 3
Pharmacological subgroup
L01X - Other Antineoplastic Agents in ATC
Available in
 |
Indonesia |
Warnings
Alcohol
CONSULT YOUR DOCTORSafety of this item for use with alcohol has not been established. Please consult your doctor.
Machinery
NOT RECOMMENDEDThis item should not be used while operating heavy machinery.
Pregnancy
NOT RECOMMENDEDThis item is not safe for use during pregnancy.
Lactation
NOT RECOMMENDEDThis item is not safe for use during lactation.
Indication
Oxaliplatin in combination with 5-fluorouracil (5-FU) and folinic acid (FA) is indicated for:
Adjuvant treatment of stage III (Duke's C) colon cancer
after complete resection of primary tumor
Treatment of metastatic colorectal cancer
Adjuvant treatment of stage III (Duke's C) colon cancer
after complete resection of primary tumor
Treatment of metastatic colorectal cancer
Dosage
18 YEARS OLD AND ABOVE
— In adjuvant setting:
The recommended dose for oxaliplatin is 85 mg/m² intravenously, repeated every 2 weeks for 12 cycles (6 months).
— In treatment of metastatic colorectal cancer:
The recommended dose for oxaliplatin is 85 mg/m² intravenously repeated every 2 weeks.
Dosage given should be adjusted according to tolerability (see "warnings and precautions").Oxaliplatin should always be administered before fluoropyrimidines. Oxaliplatin is administered as a 2-6 hours intravenous infusion in 250 to 500 ml of 5% dextrose infusion to give a concentration not less than 0.2 mg/ml. Oxaliplatin was mainly used in combination with continuous infusion 5-fluorouracil based regimens. For the two-weekly treatment schedule 5-fluorouracil regimens combining bolus and continuous infusion were used. In the event of extravasation, administration must be discontinued immediately.
UP TO 18 YEARS
Not recommended
Dosage given should be adjusted according to tolerability (see "warnings and precautions").Oxaliplatin should always be administered before fluoropyrimidines. Oxaliplatin is administered as a 2-6 hours intravenous infusion in 250 to 500 ml of 5% dextrose infusion to give a concentration not less than 0.2 mg/ml. Oxaliplatin was mainly used in combination with continuous infusion 5-fluorouracil based regimens. For the two-weekly treatment schedule 5-fluorouracil regimens combining bolus and continuous infusion were used. In the event of extravasation, administration must be discontinued immediately.
PATIENTS WITH SEVERE RENAL IMPAIRMENT
Oxaliplatin must not be administered in patients with severe renal impairment
— In adjuvant setting:
The recommended dose for oxaliplatin is 85 mg/m² intravenously, repeated every 2 weeks for 12 cycles (6 months).
— In treatment of metastatic colorectal cancer:
The recommended dose for oxaliplatin is 85 mg/m² intravenously repeated every 2 weeks.
Dosage given should be adjusted according to tolerability (see "warnings and precautions").Oxaliplatin should always be administered before fluoropyrimidines. Oxaliplatin is administered as a 2-6 hours intravenous infusion in 250 to 500 ml of 5% dextrose infusion to give a concentration not less than 0.2 mg/ml. Oxaliplatin was mainly used in combination with continuous infusion 5-fluorouracil based regimens. For the two-weekly treatment schedule 5-fluorouracil regimens combining bolus and continuous infusion were used. In the event of extravasation, administration must be discontinued immediately.
UP TO 18 YEARS
Not recommended
Dosage given should be adjusted according to tolerability (see "warnings and precautions").Oxaliplatin should always be administered before fluoropyrimidines. Oxaliplatin is administered as a 2-6 hours intravenous infusion in 250 to 500 ml of 5% dextrose infusion to give a concentration not less than 0.2 mg/ml. Oxaliplatin was mainly used in combination with continuous infusion 5-fluorouracil based regimens. For the two-weekly treatment schedule 5-fluorouracil regimens combining bolus and continuous infusion were used. In the event of extravasation, administration must be discontinued immediately.
PATIENTS WITH SEVERE RENAL IMPAIRMENT
Oxaliplatin must not be administered in patients with severe renal impairment