Rx Item-Pamidronate 30Mg 10Ml Vial 10Ml By Hospira Worldwide

PAMIDRONATE DISODIUM- pamidronate disodium injection, solution
Teva Parenteral Medicines, Inc.

1 INDICATIONS AND USAGE

1.1 Hypercalcemia of Malignancy
Pamidronate disodium injection is indicated for the treatment of moderate or severe hypercalcemia associated with malignancy, with or without bone metastases.

1.2 Paget�s Disease
Pamidronate disodium injection is indicated for the treatment of patients with moderate to severe Paget�s disease of bone.

1.3 Osteolytic Bone Metastases of Breast Cancer and Osteolytic Lesions of Multiple Myeloma


Pamidronate disodium injection is indicated in conjunction with standard antineoplastic therapy, for the treatment of osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma [see Clinical Studies (14.3)].

1.4 Limitations of Use
The safety and efficacy of pamidronate disodium injection in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions has not been established.

2 DOSAGE AND ADMINISTRATION

2.1 Hypercalcemia of Malignancy
Vigorous saline hydration, should be initiated promptly along with pamidronate therapy and if possible the urine output should be about 2 L/day throughout treatment [see Warnings and Precautions (5.2)].

Patients who receive pamidronate disodium injection should have serum creatinine assessed prior to each treatment [see Warnings and Precautions (5.1)]. Treatment should be withheld for renal deterioration.

Moderate Hypercalcemia

The recommended dose of pamidronate disodium injection in moderate hypercalcemia (corrected serum calcium* of approximately 12 mg/dL to 13.5 mg/ dL) is 60 mg to 90 mg given as a single-dose, intravenous infusion over 2 hours to 24 hours. Longer infusions (i.e., greater than 2 hours) may reduce the risk for renal toxicity, particularly in patients with preexisting renal impairment.

Severe Hypercalcemia

The recommended dose of pamidronate disodium injection in severe hypercalcemia (corrected serum calcium* >13.5 mg/ dL) is 90 mg given as a single-dose, intravenous infusion over 2 to 24 hours. Longer infusions (i.e., greater than 2 hours) may reduce the risk for renal toxicity, particularly in patients with preexisting renal insufficiency/impairment.

*Albumin-corrected serum calcium = serum calcium, mg/dL + 0.8 (4-serum albumin, g/dL).

RX ITEM-Pamidronate 30Mg 10Ml Vial 10Ml
NDC 61703-0324-18 UPC/GTIN No.3-61703-32418-4 Mfg.Part No.32418

Pamidronate 30Mg 10Ml Vial 10Ml By Hospi
BRAND: PAMIDRONATE NDC: 61703-0324-18,61703032418 UPC: 3-61703-32418-4,361703324184

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