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zoledronic acid for injection 5 MG BAG

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zoledronic acid for injection 5 MG BAG Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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1 INDICATIONS AND USAGE

1.5 Paget's Disease of Bone

Zoledronic acid is indicated for treatment of Paget's disease of bone in men and women. Treatment is indicated in...

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2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

Zoledronic acid injection must be administered as an intravenous infusion over no less than 15...

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3 DOSAGE FORMS AND STRENGTHS

5 mg in a 100 mL ready to infuse solution.

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4 CONTRAINDICATIONS

Zoledronic acid is contraindicated in patients with the following conditions:

Hypocalcemia [see Warnings and...
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5 WARNINGS AND PRECAUTIONS

5.1 Drug Products with Same Active Ingredient

Zoledronic Acid Injection contains the same active ingredient found in Zometa, used for...

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6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the...

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7 DRUG INTERACTIONS

No in vivo drug interaction studies have been performed for zoledronic acid. In vitro and ex vivo studies showed low...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Available data on the...

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10 OVERDOSAGE

Clinical experience with acute overdosage of zoledronic acid solution for intravenous infusion is limited. Patients who have received doses higher than those recommended should be carefully monitored....

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11 DESCRIPTION

Zoledronic Acid Injection contains zoledronic acid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronic acid is designated chemically as (1-Hydroxy-2-imidazol-1-yl-...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Zoledronic acid is a bisphosphonate and acts primarily on bone. It is an inhibitor of osteoclast-mediated bone...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis: Lifetime...

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14 CLINICAL STUDIES

14.5 Treatment of Paget's Disease of Bone

Zoledronic acid was studied in male and female patients with moderate to severe Paget's disease of bone...

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16 HOW SUPPLIED/STORAGE AND HANDLING

Zoledronic Acid Injection is available in single-dose sterile Non-PVC flexible containers. Each bag contains 5 mg/100 mL.

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MEDICATION GUIDE

Zoledronic Acid Injection (ZOE-le-DRON-ik AS-id)

Read the Medication Guide that comes with Zoledronic Acid Injection before you start taking it and each time you get a refill...

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