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oxaliplatin injection Index Section

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

2.2 Dose Modifications for Adverse Reactions

2.3 Dose Modifications for Patients with Renal Impairment

2.4 Preparation and Administration

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

5.2 Peripheral Sensory Neuropathy

5.3 Severe Myelosuppression

5.4 Posterior Reversible Encephalopathy Syndrome

5.5 Pulmonary Toxicity

5.6 Hepatotoxicity

5.7 QT Interval Prolongation and Ventricular Arrhythmias

5.8 Rhabdomyolysis

5.9 Hemorrhage

5.10 Embryo-Fetal Toxicity

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Drugs that Prolong the QT Interval

7.2 Use with Nephrotoxic Products

7.3 Use with Anticoagulants

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.3 Females and Males of Reproductive Potential

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Patients with Renal Impairment

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

14.1 Adjuvant Treatment with Oxaliplatin in Combination with Fluorouracil and Leucovorin

14.2 Previously Untreated Advanced Colorectal Cancer

14.3 Previously Treated Advanced Colorectal Cancer

15 REFERENCES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.
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