RX ITEM-Zoledronic Ac 4Mg/5Ml Vial 5Ml By Apotex Corp

ZOMETA- zoledronic acid injection, solution, concentrate
Novartis Pharmaceuticals Corporation


INDICATIONS AND USAGE
1.1 Hypercalcemia of Malignancy
Zometa 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
Zometa 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.
1.3 Important Limitation of Use
The safety and efficacy of Zometa in the treatment of hypercalcemia associated with hyperparathyroidism or with other nontumor-related conditions have not been established.
2 DOSAGE AND ADMINISTRATION
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Hypercalcemia of Malignancy
The maximum recommended dose of Zometa in hypercalcemia of malignancy (albumin-corrected serum calcium greater than or equal to 12 mg/dL [3.0 mmol/L]) is 4 mg. The 4 mg dose must be given as a single-dose intravenous infusion over no less than 15 minutes. Patients who receive Zometa should have serum creatinine assessed prior to each treatment.
DOSAGE FORMS AND STRENGTHS
4 mg per 100 mL single-use ready-to-use bottle
4 mg per 5 mL single-use vial of concentrate

RX ITEM-Zoledronic Ac 4Mg/5Ml Vial 5Ml B
NDC 60505-6110-00 UPC/GTIN No.6-05056-11000-2 Mfg.Part No.611000

Zoledronic Ac 4Mg/5Ml Vial 5Ml By Apotex
BRAND: ZOLEDRONIC NDC: 60505-6110-00,60505611000 UPC: 6-05056-11000-2,605056110002 Apotex Corp

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