propofol injectable emulsion (contains benzyl alcohol) How Supplied/Storage and Handling

(propofol injectable emulsion (contains benzyl alcohol))

16 HOW SUPPLIED/STORAGE AND HANDLING

Propofol Injectable Emulsion, USP is supplied as follows:

Unit of SaleConcentration

NDC 0409-4699-30
Carton of 5 Single-Patient Use Fliptop vials

200 mg/20 mL
(10 mg/mL)

NDC 0409-6010-25
Tray of 25 Single-Patient Use Fliptop vials

200 mg/20 mL
(10 mg/mL)

NDC 0409-4699-33
Tray of 20 Single-Patient Use Fliptop vials

500 mg/50 mL
(10 mg/mL)

NDC 0409-4699-24
Tray of 10 Single-Patient Use Fliptop vials

1 g/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 at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature]. 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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How Supplied/Storage and Handling

16 HOW SUPPLIED/STORAGE AND HANDLING

Propofol Injectable Emulsion, USP is supplied as follows:

Unit of SaleConcentration

NDC 0409-4699-30
Carton of 5 Single-Patient Use Fliptop vials

200 mg/20 mL
(10 mg/mL)

NDC 0409-6010-25
Tray of 25 Single-Patient Use Fliptop vials

200 mg/20 mL
(10 mg/mL)

NDC 0409-4699-33
Tray of 20 Single-Patient Use Fliptop vials

500 mg/50 mL
(10 mg/mL)

NDC 0409-4699-24
Tray of 10 Single-Patient Use Fliptop vials

1 g/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 at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature]. 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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