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PROPOFOL (CIVICA) How Supplied/Storage and Handling (propofol injectable emulsion)

16 HOW SUPPLIED/STORAGE AND HANDLING

Propofol Injectable Emulsion, USP is supplied as follows:

Unit of SaleConcentration

NDC 72572-590-10
Carton of 10 Single-Patient Use Vials

200 mg/20 mL
(10 mg/mL)

NDC 72572-601-20
Carton of 20 Single-Patient Use Vials

500 mg/50 mL
(10 mg/mL)

NDC 72572-612-10
Carton of 10 Single-Patient Use Vials

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°C to 25°C (40°F 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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