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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

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