ZOLEDRONIC ACID INJECTION - FOR INTRAVENOUS INFUSION (zoledronic acid for injection - FOR INTRAVENOUS INFUSION)

zoledronic acid for injection 5 MG BAG Quick Finder

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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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Report Adverse Event

Pfizer Safety

To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at
(800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.