HIGHLIGHTS OF PRESCRIBING INFORMATION
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zoledronic acid for injection 5 MG BAG
zoledronic acid for injection 5 MG BAG Quick Finder
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...
2 DOSAGE AND ADMINISTRATION
2.1 Important Administration Instructions
Zoledronic acid injection must be administered as an intravenous infusion over no less than 15...
3 DOSAGE FORMS AND STRENGTHS
5 mg in a 100 mL ready to infuse solution.
Zoledronic acid is contraindicated in patients with the following conditions:
- Hypocalcemia [see Warnings and...
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...
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the...
7 DRUG INTERACTIONS
No in vivo drug interaction studies have been performed for zoledronic acid. In vitro and ex vivo studies showed low...
8 USE IN SPECIFIC POPULATIONS
Available data on the...
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....
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-...
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...
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
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...
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.
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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