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Fluorourasil 500mg / 10ml injection

Ferron Par Pharmaceuticals

Ingredients in every 10 ml

Fluorouracil 500 mg

Each package contains

1 vial of 10 ml

Dosage form

injection

Dosage formInjection

Flavour

None

W.H.O. classification

L01B
L01B

A.T.C. Level 1

Anatomical Main group

L - Antineoplastic and immunomodulating agents
L01B

A.T.C. Level 2

Therapeutic subgroup

L01 - Antineoplastic Agents
L01B

A.T.C. Level 3

Pharmacological subgroup

L01B - Antimetabolites

Available in

Indonesia

Warnings

Alcohol

CONSULT YOUR DOCTORSafety of this item for use with alcohol has not been established. Please consult your doctor.

Machinery

CAUTIONThis item may not be safe for use while operating heavy machinery. Use with caution and after consultation with your doctor.

Pregnancy

NOT RECOMMENDEDThis item is not safe for use during pregnancy.

Lactation

NOT RECOMMENDEDThis item is not safe for use during lactation.

Indication

For palliative treatment of carcinoma of the colon, rectum, breast, stomach and pancreas in patients who are considered incurable by surgery or other means.

Dosage

18 YEARS OLD AND ABOVE
Usual dosage
12 mg/kg i.v once daily for 4 successive days. The maximum daily dose of fluorouracil is 800 mg. If no toxicity is observed, 6 mg/kg are given on days 6, 8, 10 and 12 (no therapy is given on days 5, 7, 9 and 11).Therapy is discontinued at the end of day 12, even if no toxicity is observed.

Poor risk patients or those with inadequate nutritional state.
6 mg/kg/day for 3 days. If no toxicity is observed, 3 mg/kg are given on day 5, 7 and 9 (no therapy on day 4, 6 and 8). The maximum daily dose is 400 mg. The above sequence of injections constitutes a course of therapy.

Maintenance therapy
When toxicity has not been a problem, it is recommended to continue therapy using either of the following schedules:
– Repeat dosage of first course every 30 days after the last day of the previous course of treatment.
– When toxic signs resulting from the initial course of therapy have subsided, administer a maintenance dosage of 10 to 15 mg/kg/week as a single dose. Do not exceed 1 g per week.
The amount of the drug to be used may vary from 9 to 45 courses of treatment during periods which ranged from 12 to 60 months.

OTHER DETAILS
Fluorouracil injection is for i.v use only and no dilution is required. Actual body weight is used for dosage calculation, except in obese patients and in the presence of abnormal fluid retention (edema, ascites), the estimated ideal body weight is used.