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PROPOFOL (CIVICA) Indications and Usage (propofol injectable emulsion)

1 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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