Country: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
ZOLEDRONIC ACID (UNII: 6XC1PAD3KF) (ZOLEDRONIC ACID ANHYDROUS - UNII:70HZ18PH24)
Hikma Pharmaceuticals USA Inc.
ZOLEDRONIC ACID
ZOLEDRONIC ACID ANHYDROUS 4 mg in 5 mL
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 mmol/L] using the formula: cCa in mg/dL=Ca in mg/dL + 0.8 (4 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. Limitations of Use The safety and efficacy of zoledronic acid injection in the treatment of hypercalcemia associated with hyperparathyroidism or with other nontumor-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 [see Advers
Zoledronic acid injection, 4 mg per 5 mL single-dose vial of concentrate Carton of 1 vial………………..NDC 0143-9642-01 Store at 25°C (77°F); excursions permitted to 15º to 30°C (59º to 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
ZOLEDRONIC ACID- ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE HIKMA PHARMACEUTICALS USA INC. ---------- 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) 01/2019 INDICATIONS AND USAGE Zoledronic acid injection is a bisphosphonate indicated for the treatment of: 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) Limitations of use: The safety and efficacy of zoledronic acid injection has not been established for use in hyperparathyroidism or nontumor-related hypercalcemia. 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) DOSAGE FORMS AND STRENGTHS Injection: 4 mg per 5 mL (0.8 mg/mL) single-dose vial of concentrate (3) CONTRAINDICATIONS Hypersensitivity to any component of zoledronic acid (4) WARNINGS AND PRECAUTIONS Patients being treated with zoledronic acid should not be treated with Reclast . (5.1) Adequately Aqra d-dokument sħiħ