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Cisplatin 50mg / 50ml injection

Ferron Par Pharmaceuticals

Product packaging may vary from one country to another.

Ingredients in every 50 ml

Cisplatin 50 mg

Each package contains

1 vial of 50 ml

Other details

Dosage form:Injection
Flavour None

W.H.O. classification

ATC Level 1 L - Antineoplastic and immunomodulating agents
ATC Level 2 L01 - Antineoplastic Agents
ATC Level 3 L01X - Other Antineoplastic Agents in ATC

Warnings

Pregnancy

NOT RECOMMENDEDThis item is not safe for use during pregnancy.

Lactation

NOT RECOMMENDEDThis item is not safe for use during lactation.

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.

Available in

Indonesia

Dosage information

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.

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.