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propofol injectable emulsion (contains edetate disodium) Indications and Usage


Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for:

Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age
Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age
Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients
Sedation for Adult Patients in Combination with Regional Anesthesia
Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients

Limitations of Use

Propofol injectable emulsion is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months because its safety and effectiveness have not been established in those populations [see Pediatric Use (8.4)].

Safety, effectiveness and dosing guidelines for propofol injectable emulsion have not been established for MAC sedation in the pediatric population; therefore, it is not recommended for this use [see Pediatric Use (8.4)].

Propofol injectable emulsion is not indicated for use in Pediatric ICU sedation since the safety of this regimen has not been established [see Pediatric Use (8.4)].

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