<p>Parenteral drug products should be inspected visually for particulate matter prior to administration.<br />
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<strong>Representative Dose Schedules and Combination for the Approved Indication of Remission Induction in Adult Acute Nonlymphocytic Leukemia</strong>: In Combination: For patients under age 60, Daunorubicin 45 mg/m2/day IV on days 1, 2, and 3 of the first course and on days 1, 2 of subsequent courses AND cytosine arabinoside 100 mg/m2/day IV infusion daily for 7 days for the first course and for 5 days for subsequent courses. For patients 60 years of age and above, Daunorubicin 30 mg/m2/day IV on days 1, 2, and 3 of the first course and on days 1, 2 of subsequent courses AND cytosine arabinoside 100 mg/m2/day IV infusion daily for 7 days for the first course and for 5 days for subsequent courses. This Daunorubicin dose-reduction is based on a single study and may not be appropriate if optimal supportive care is available.<br />
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<strong>Representative Dose Schedule and Combination for the Approved Indication of Remission Induction in Pediatric Acute Lymphocytic Leukemia</strong>: In Combination: Daunorubicin 25 mg/m2 IV on day 1 every week, Vincristine 1.5 mg/m2 IV on day 1 every week, prednisone 40 mg/m2 PO daily. Generally, a complete remission will be obtained within four such courses of therapy; however, if after four courses the patient is in partial remission, an additional one or, if necessary, two courses may be given in an effort to obtain a complete remission. In children less than 2 years of age or below 0.5 m2 body surface area, it has been recommended that the Daunorubicin dosage calculation should be based on weight (1 mg/kg) instead of body surface area.<br />
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<strong>Representative Dose Schedules and Combination for the Approved Indication of Remission Induction in Adult Acute Lymphocytic Leukemia</strong>: In Combination: Daunorubicin 45 mg/m2/day IV on days 1, 2, and 3 and Vincristine 2 mg IV on days 1, 8, and 15; prednisone 40 mg/m2/day PO on days 1 through 22, then tapered between days 22 to 29; L-asparaginase 500 IU/kg/day x 10 days IV on days 22 through 32. Or, as directed by the registered physicians.</p>