Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
ZOLEDRONIC ACID (UNII: 6XC1PAD3KF) (ZOLEDRONIC ACID ANHYDROUS - UNII:70HZ18PH24)
Gland Pharma Limited
INTRAVENOUS
PRESCRIPTION DRUG
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]). 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. Limitation of Use The safety and efficacy of Zoledronic Acid Injection in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions have not been established. Hypersensitivity to Zoledronic Acid or Any Components of Zoledronic Acid Injection Hypersensitivity reactions including rare cases of urticaria and angioedema, and very rare cases of anaphylactic reaction/shock have been reported
Zoledronic Acid Injection is supplied as follows: NDC Zoledronic Acid Injection (0.04 mg/mL) Package Factor 68083-142-01 4 mg/100 mL single-dose ready-to-use bottle 1 bottle per carton Storage Conditions Store at 25ºC (77ºF); excursions permitted between 15º and 30ºC (59º and 86ºF). [See USP Controlled Room Temperature.] Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.
Abbreviated New Drug Application
ZOLEDRONIC ACID - ZOLEDRONIC ACID INJECTION GLAND PHARMA LIMITED ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ZOLEDRONIC ACID INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZOLEDRONIC ACID INJECTION. ZOLEDRONIC ACID INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2001 RECENT MAJOR CHANGES Warnings and Precautions, Embryo-Fetal Toxicity (5.10) 12/2018 INDICATIONS AND USAGE Zoledronic Acid Injection is a bisphosphonate indicated for the treatment of: (1) • Hypercalcemia of malignancy. (1.1) • 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. (1.2) Limitation of Use: The safety and efficacy of Zoledronic Acid Injection has not been established for use in hyperparathyroidism or non-tumor-related hypercalcemia. (1) DOSAGE AND ADMINISTRATION Hypercalcemia of malignancy (2.1) • 4 mg as a single-use intravenous infusion over no less than 15 minutes. • 4 mg as retreatment after a minimum of 7 days. Multiple myeloma and bone metastasis from solid tumors. (2.2) • 4 mg as a single-use intravenous infusion over no less than 15 minutes every 3 to 4 weeks for patients with creatinine clearance of greater than 60 mL/min. • Reduce the dose for patients with renal impairment. • Coadminister oral calcium supplements of 500 mg and a multiple vitamin containing 400 International units of vitamin D daily. Administer through a separate vented infusion line and do not allow to come in contact with any calcium or divalent cation- containing solutions. (2.3) (2) DOSAGE FORMS AND STRENGTHS 4 mg/100 mL (0.04 mg/mL) single-dose ready-to-use bottle (3) (3) CONTRAINDICATIONS Hypersensitivity to any component of Zoledronic Acid Injection (4) (4) WARNINGS AND PRECAUTIONS • Patients being treated with Zoledronic Acid Injection should not be treate Прочитайте повний документ