Cisplatin concentrate for solution for infusion is to be diluted before use (see Special precautions for disposal and other handling under Cautions for Usage).
The diluted solution should be administered only intravenously by infusion (see as follows).
For administration, any device containing aluminium that may come in contact with cisplatin (sets for intravenous infusion, needles, catheters, syringes) must be avoided (see Incompatibilities under Cautions for Usage).
Adults and children: The cisplatin dose depends on the primary disease, the expected reaction, and on whether cisplatin is used for monotherapy or as a component of a combination chemotherapy. The dose directions are applicable for both adults and children. For recommendations on the dose applicable, based on the diagnosis and the clinical condition, the current medical literature should be consulted.
For monotherapy, the following two dose regimens are recommended: Single dose of 50 to 120 mg/m2 body surface area every 3 to 4 weeks; 15 to 20 mg/m2/day for five days, every 3 to 4 weeks.
If cisplatin is used in combination chemotherapy, the dose of cisplatin must be reduced. A typical dose is 20 mg/m2 or more once every 3 to 4 weeks unless in the combination therapy of small-cell and non-small-cell lung carcinoma, in which a typical dose of 80 mg/m2 is administered.
Further dose recommendations are to be based upon current medical insights, to be obtained from the literature or/and the appropriate working parties.
For warnings and precautions to be considered prior to the start of the next treatment cycle, see Warnings and Precautions.
In patients with renal dysfunction or bone marrow depression, the dose should be reduced adequately.
The cisplatin solution for infusion prepared according to instructions (see Special precautions for disposal and other handling under Cautions for Usage) should be administered by intravenous infusion over a period of 6 to 8 hours.
Adequate hydration must be maintained from 2 to 12 hours prior to administration until minimum 6 hours after the administration of cisplatin.
Hydratation is necessary to cause sufficient diuresis during and after treatment with cisplatin. It is realised by intravenous infusion of one of the following solutions: Sodium chloride solution 0.9%; Mixture of sodium chloride solution 0.9% and glucose solution 5% (1:1).
Hydration prior to treatment with cisplatin: Intravenous infusion of 100 to 200 ml/hour for a period of 6 to 12 hours.
Hydration after termination of the administration of cisplatin: Intravenous infusion of another 2 litres at a rate of 100 to 200 ml per hour for a period of 6 to 12 hours.
Forced diuresis may be required should the urine secretion be less than 100 to 200 ml/hour after hydration. Forced diuresis may be realised by intravenously administering 37.5 g mannitol as a 10% solution (375 ml mannitol solution 10%), or by administration of a diuretic if the kidney functions are normal. The administration of mannitol or a diuretic is also required when the administrated cisplatin dose is higher than 60 mg/m2 of body surface.
It is necessary that the patient drinks large quantities of liquids for 24 hours after the cisplatin infusion to ensure adequate urine secretion.