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propofol injectable emulsion (contains edetate disodium) How Supplied/Storage and Handling

HOW SUPPLIED

Propofol Injectable Emulsion, USP is available as follows:

Propofol Injectable Emulsion is an isotonic white to almost white homogeneous emulsion containing 10 mg/mL of Propofol drug substance.

Unit of SaleConcentration
NDC 0069-0209-05
Carton of 5 Single-Patient Use Vials
1%
200 mg/20 mL
(10 mg/mL)
NDC 0069-0209-10
Carton of 10 Single-Patient Use Vials
1%
200 mg/20 mL
(10 mg/mL)
NDC 0069-0209-25
Carton of 25 Single-Patient Use Vials
1%
200 mg/20 mL
(10 mg/mL)
NDC 0069-0234-01
Carton of 1 Single-Patient Use Vials
1%
500 mg/50 mL
(10 mg/mL)
NDC 0069-0234-05
Carton of 5 Single-Patient Use Vials
1%
500 mg/50 mL
(10 mg/mL)
NDC 0069-0234-20
Carton of 20 Single-Patient Use Vials
1%
500 mg/50 mL
(10 mg/mL)
NDC 0069-0248-01
Carton of 1 Single-Patient Use Vials
1%
1000 mg/100 mL
(10 mg/mL)
NDC 0069-0248-10
Carton of 10 Single-Patient Use Vials
1%
1000 mg/100 mL
(10 mg/mL)

Propofol undergoes oxidative degradation, in the presence of oxygen, and is therefore packaged under nitrogen to eliminate this degradation path.

Store between 4 to 25°C (40 to 77°F). Do not freeze. Shake well before use.

Do not use if there is evidence of excessive creaming or aggregation, if large droplets are visible, or if there are other forms of phase separation indicating that the stability of the product has been compromised. Slight creaming, which should disappear after shaking, may be visible upon prolonged standing.

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