Cisplatin 1.0 mg/ml concentrate for solution for infusion is to be diluted before administration.
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.
Adults and children: The cisplatin dosage depends on the primary disease, the expected reaction, and on whether cisplatin is used for monotherapy or as a component of combination chemotherapy. The dosage directions are applicable for both adults and children.
For monotherapy, the following two dosage regimens are recommended: Single dose of 50 to 120 mg/m2 body surface 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.
For treatment of cervical cancer cisplatin is used in combination with radiotherapy. A typical dose is 40 mg/m2 weekly for 6 weeks.
For warnings and precautions to be considered prior to the start of the next treatment cycle.
In patients with renal dysfunction or bone marrow depression, the dose should be reduced adequately.
Route of Administration: The cisplatin solution for infusion prepared according to instructions 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. Hydration 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, with a total amount of at least 1L.
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 37.5g mannitol as a 10% solution (375 ml mannitol solution 10%), or by administration of a diuretic if the kidney functions are normal.
Mode of administration: Intravenous Administration.