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rocuronium bromide injection Index Section

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosing and Administration Information

2.2 Dose for Tracheal Intubation

2.3 Rapid Sequence Intubation

2.4 Maintenance Dosing

2.5 Use by Continuous Infusion

2.6 Dosage in Specific Populations

2.7 Preparation for Administration of Rocuronium Bromide Injection

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Appropriate Administration and Monitoring

5.2 Anaphylaxis

5.3 Risk of Death due to Medication Errors

5.4 Need for Adequate Anesthesia

5.5 Residual Paralysis

5.6 Long-Term Use in an Intensive Care Unit

5.7 Malignant Hyperthermia (MH)

5.8 Prolonged Circulation Time

5.9 QT Interval Prolongation

5.10 Conditions/Drugs Causing Potentiation of, or Resistance to, Neuromuscular Block

5.11 Incompatibility with Alkaline Solutions

5.12 Increase in Pulmonary Vascular Resistance

5.13 Use In Patients with Myasthenia

5.14 Extravasation

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Antibiotics

7.2 Anticonvulsants

7.3 Inhalation Anesthetics

7.4 Lithium Carbonate

7.5 Local Anesthetics

7.6 Magnesium

7.7 Nondepolarizing Muscle Relaxants

7.8 Procainamide

7.9 Propofol

7.10 Quinidine

7.11 Succinylcholine

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Labor and Delivery

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Patients with Hepatic Impairment

8.7 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 Adult Patients

14.2 Geriatric Patients

14.3 Pediatric Patients

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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