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linezolid injection in sodium chloride

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linezolid injection in sodium chloride Quick Finder

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HIGHLIGHTS OF PRESCRIBING INFORMATION

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1 INDICATIONS AND USAGE

1.1 Nosocomial Pneumonia

Linezolid is indicated for the treatment of nosocomial pneumonia caused by Staphylococcus...

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2 DOSAGE AND ADMINISTRATION

2.1 General Dosage and Administration

The recommended dosage for linezolid injection for the treatment of infections is described in...

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3 DOSAGE FORMS AND STRENGTHS

Linezolid injection: 600 mg/300 mL (2 mg/mL) linezolid in single-dose, ready-to-use flexible plastic VisIV™ container in a foil laminate overwrap.

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4 CONTRAINDICATIONS

4.1 Hypersensitivity

Linezolid injection is contraindicated for use in patients who have known hypersensitivity to linezolid or any of the other...

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5 WARNINGS AND PRECAUTIONS

5.1 Myelosuppression

Myelosuppression (including anemia, leukopenia, pancytopenia, and thrombocytopenia) has been reported in patients...

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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

7.1 Monoamine Oxidase Inhibitors

Linezolid is a reversible, nonselective inhibitor of monoamine oxidase [see...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Available data from...

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10 OVERDOSAGE

In the event of overdosage, supportive care is advised, with maintenance of glomerular filtration. Hemodialysis may facilitate more rapid elimination of linezolid. In a Phase 1 clinical trial, approximately 30...

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11 DESCRIPTION

Linezolid injection contains linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is (S)-N...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Lifetime studies in animals have not been conducted to evaluate the carcinogenic...

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14 CLINICAL STUDIES

14.1 Adults

Nosocomial Pneumonia

Adult patients with...

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16 HOW SUPPLIED/STORAGE AND HANDLING

Linezolid injection is available in a single-dose, ready-to-use flexible plastic container (VisIV™ Container) in a foil laminate overwrap. The container is available in the following...

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17 PATIENT COUNSELING INFORMATION

Important Administration Instructions

Advise patients that linezolid injection may be taken with or...

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Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

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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
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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.