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ZOLEDRONIC ACID INJECTION - PREMIXED SOLUTION FOR INTRAVENOUS INFUSION (FOR SINGLE DOSE) (zoledronic acid for injection - PREMIXED SOLUTION FOR INTRAVENOUS INFUSION (FOR SINGLE DOSE)) Indications and Usage

1 INDICATIONS AND USAGE

1.1 Hypercalcemia of Malignancy

Zoledronic Acid Injection is indicated for the treatment of hypercalcemia of malignancy defined as an albumin-corrected calcium (cCa) of greater than or equal to 12 mg/dL [3.0 mmol/L] using the formula: cCa in mg/dL = Ca in mg/dL + 0.8 (4.0 g/dL - patient albumin (g/dL)).

1.2 Multiple Myeloma and Bone Metastases of Solid Tumors

Zoledronic Acid Injection is indicated for the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy.

Limitations of Use

The safety and efficacy of zoledronic acid in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions have not been established.

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