Propofol — 200MG, Emulsion for injection, carton of 10 × 20 mL vials

Propofol — 200MG, Emulsion for injection, carton of 10 × 20 mL vials

Propofol is a emulsion for injection for intravenous use. 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 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 have not been established for MAC sedation in the ped

• Active ingredient or product type: PROPOFOL
• Strength/concentration: 200MG
• Dosage form and route: Emulsion for injection, Intravenous
• Exact package presentation: carton of 10 × 20 mL vials
• NDC/item number: 0641-6194-10
• Manufacturer: HIKMA PHARMACEUTICALS USA INC
• Storage/handling: Store between 4° to 25°C (40° to 77°F). DO NOT FREEZE.
• Status: Rx only

Important safety information: Hypersensitivity Reactions : Serious and sometimes fatal reactions ( 5.1 ) Microbial Contamination : Strict aseptic technique must be maintained during handling.

Refer to the current product labeling for complete indications, preparation or administration instructions, contraindications, warnings, precautions, and storage requirements.