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propofol injectable emulsion (contains edetate disodium) Index Section

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Information

2.2 Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age

2.3 Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age

2.4 Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients

2.5 Clinical Responses and Dose Titrations

2.6 Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients

2.7 Summary of Dosage Guidelines

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Anaphylactic and Anaphylactoid Reactions

5.2 Risks of Microbial Contamination

5.3 Risks of Pediatric Neurotoxicity

5.4 Risks of Bradycardia, Asystole, and Cardiac Arrest

5.5 Risk of Seizures

5.6 Neurosurgical Anesthesia

5.7 Cardiac Anesthesia

5.8 Use for Intensive Care Unit Sedation of Intubated, Mechanically Ventilated Adult Patients

5.9 Risks of Propofol Infusion Syndrome in Patients with ICU Sedation

5.10 Risk of Elevations in Serum Triglycerides

5.11 Risks of Zinc Losses

5.12 Use in the Elderly, Debilitated, or ASA-PS III or IV Patients

5.13 Risk of Transient Local Pain

5.14 Risks of Local Reactions

5.15 Risks of Aggregation if Administered through the Same Intravenous Catheter with Blood or Plasma

5.16 Risk of Postoperative Unconsciousness

5.17 Risks of Perioperative Myoclonia

5.18 Risks of Pulmonary Edema

5.19 Risks of Unexplained Postoperative Pancreatitis

6 ADVERSE REACTIONS

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Hepatic Impairment

8.7 Renal Impairment

9 DRUG ABUSE AND DEPENDENCE

9.2 Abuse

10 OVERDOSAGE

10.1 Symptoms

10.2 Treatment

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

13.2 Animal Toxicology and/or Pharmacology

14 CLINICAL STUDIES

14.1 Pediatric Anesthesia

14.2 Neuroanesthesia

14.3 Cardiac Anesthesia

14.4 Intensive Care Unit (ICU) Sedation in Adult Patients

14.5 Intensive Care Unit (ICU) Sedation in Pediatric Patients

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

17.1 Impaired Mental Alertness

17.2 Effect of Anesthetic and Sedation Drugs on Early Brain Development

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