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Cisplatin 50mg / 50ml injection

Ferron Par Pharmaceuticals

Ingredients in every 50 ml

Cisplatin 50 mg

Each package contains

1 vial of 50 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

CONSULT YOUR DOCTORSafety of this item for use while operating heavy machinery has not been established. Please consult 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

Cisplatin is indicated as palliative therapy either alone or in combination with other approved chemotherapeutic agents and in patients who have already received appropriate surgical and/or radio therapeutic procedures in the management of metastatic testicular tumors or metastatic ovarian tumors and advanced bladder cancer.

Dosage

PREHYDRATION THERAPY
A prehydration therapy is required 8-12 hours before the cisplatin administration. This consists of 1-2 l physiological saline solution/m² body surface area (BSA) per infusion over at least 2-3 hours.

FOR MONOCHEMOTHERAPY
50-120 mg cisplatin/m² BSA at 3-4 weeks intervals
or
50 mg cisplatin/m² BSA on day 1 and 8 at 3-4 weeks intervals;
or
15-20 mg cisplatin /m² BSA on day 1-5 at 3-4 weeks intervals.

Cisplatin is generally administered in chemotherapeutic combinations in which the dose is accordingly reduced.

POSTHYDRATION THERAPY
Adequate fluids must be given during the period after the cisplatin administration i.e. in the (6-12) 24 hours following the drug administration (this consists of 2-3 l physiological saline solution/m² BSA together with a 5% glucose solution at a ratio of 1:1.5). The urine volume during the posthydration should be at least 100-200 ml/hours. A forced diuresis must be induced in the case of inadequate excretion.

FORCED DIURESIS
For patients who have received proper prehydration and posthydration therapy and cisplatin doses below 60 mg/m² BSA and who have normal renal function, the administration of mannitol to induce a diuresis can be replaced by careful balancing and weight control. Mannitol must be administered when the retention ≥1000 ml. For cisplatin doses above 60 mg/m² BSA, mannitol administration (8 g/m²) BSA is obligatory immediately prior to the first cisplatin administration. Only after the onset of a minimal diuresis of 250 ml within 30 minutes the cisplatin administration may be started.