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zoledronic acid for injection 4 MG BAG

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Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

zoledronic acid for injection 4 MG BAG Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

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

1.1 Hypercalcemia of Malignancy

Zoledronic Acid Injection is indicated for the treatment of hypercalcemia of malignancy defined as an albumin-...

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2 DOSAGE AND ADMINISTRATION

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

...
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3 DOSAGE FORMS AND STRENGTHS

4 mg/100 mL (0.04 mg/mL) single-dose premixed bag.

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4 CONTRAINDICATIONS

Hypersensitivity to Zoledronic Acid or Any Components of Zoledronic Acid Injection

Hypersensitivity reactions including...

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5 WARNINGS AND PRECAUTIONS

5.1 Drugs with Same Active Ingredient or in the Same Drug Class

Zoledronic Acid Injection contains the same active ingredient as found in...

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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

In vitro studies indicate that the plasma protein binding of zoledronic acid is low, with the unbound fraction ranging from 60% to 77%. In vitro ...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Based on findings from...

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10 OVERDOSAGE

Clinical experience with acute overdosage of zoledronic acid is limited. Two patients received zoledronic acid 32 mg over 5 minutes in clinical trials. Neither patient experienced any clinical or laboratory...

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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

The principal pharmacologic action of zoledronic acid is inhibition of bone resorption. Although the antiresorptive...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Standard lifetime carcinogenicity bioassays were conducted in mice and rats. Mice...

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14 CLINICAL STUDIES

14.1 Hypercalcemia of Malignancy

Two identical multicenter, randomized, double-blind, double-dummy studies of zoledronic acid 4 mg given as a 5-...

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16 HOW SUPPLIED/STORAGE AND HANDLING

4 mg/100 mL (0.04 mg/mL) single-dose premixed bag

...
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17 PATIENT COUNSELING INFORMATION

Drugs with Same Active Ingredient or in the Same Drug Class

Inform patients not to take Reclast or other...

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Manufactured by:
Laboratorios Grifols, SA
Barcelona, Spain

Distributed by Hospira, Inc., Lake Forest, IL...

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