PROPOFOL (CIVICA) Patient Counseling Information

(propofol injectable emulsion)

17 PATIENT COUNSELING INFORMATION

17.1 Impaired Mental Alertness

Advise patients that performance of activities requiring mental alertness, such as operating a motor vehicle or hazardous machinery or signing legal documents may be impaired for some time after general anesthesia or sedation.

17.2 Effect of Anesthetic and Sedation Drugs on Early Brain Development

Studies conducted in young animals and children suggest repeated or prolonged use of general anesthetic or sedation drugs in children younger than 3 years may have negative effects on their developing brains. Discuss with parents and caregivers the benefits, risks, and timing and duration of surgery or procedures requiring anesthetic and sedation drugs.

This product’s labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

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Patient Counseling Information

17 PATIENT COUNSELING INFORMATION

17.1 Impaired Mental Alertness

Advise patients that performance of activities requiring mental alertness, such as operating a motor vehicle or hazardous machinery or signing legal documents may be impaired for some time after general anesthesia or sedation.

17.2 Effect of Anesthetic and Sedation Drugs on Early Brain Development

Studies conducted in young animals and children suggest repeated or prolonged use of general anesthetic or sedation drugs in children younger than 3 years may have negative effects on their developing brains. Discuss with parents and caregivers the benefits, risks, and timing and duration of surgery or procedures requiring anesthetic and sedation drugs.

This product’s labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

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