Cisplatin 10mg/10ml injection
Ferron Par Pharmaceuticals
Ingredients in every 10 ml
Each package contains
|ATC Level 1||L - Antineoplastic and immunomodulating agents|
|ATC Level 2||L01 - Antineoplastic Agents|
|ATC Level 3||L01X - Other Antineoplastic Agents in ATC|
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.
DOSAGES 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.
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.
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.
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.