Propofol: Package Insert and Label Information (Page 6 of 6)

Handling Procedures

General

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Clinical experience with the use of in-line filters and Propofol Injectable Emulsion during anesthesia or ICU/MAC sedation is limited. Propofol Injectable Emulsion should only be administered through a filter with a pore size of 5 micron or greater unless it has been demonstrated that the filter does not restrict the flow of Propofol Injectable Emulsion and/or cause the breakdown of the emulsion. Filters should be used with caution and where clinically appropriate. Continuous monitoring is necessary due to the potential for restricted flow and/or breakdown of the emulsion.

Do not use if there is evidence of separation of the phases of the emulsion.

Rare cases of self-administration of Propofol Injectable Emulsion by health care professionals have been reported, including some fatalities (see DRUG ABUSE AND DEPENDENCE).

Strict aseptic technique must always be maintained during handling. Propofol Injectable Emulsion is a single access parenteral product (single patient infusion vial) which contains 0.1% sodium benzoate to inhibit the rate of growth of microorganisms, up to 12 hours, in the event of accidental extrinsic contamination. However, Propofol Injectable Emulsion can still support the growth of microorganisms as it is not an antimicrobially preserved product under USP standards. Do not use if contamination is suspected. Discard unused drug product as directed within the required time limits. There have been reports in which failure to use aseptic technique when handling Propofol Injectable Emulsion was associated with microbial contamination of the product and with fever, infection/sepsis, other life‑threatening illness, and/or death.

There have been reports, in the literature and other public sources, of the transmission of bloodborne pathogens (such as Hepatitis B, Hepatitis C, and HIV) from unsafe injection practices, and use of propofol vials intended for single use on multiple persons. Propofol Injectable Emulsion vials are never to be accessed more than once or used on more than one person.

Propofol, with sodium benzoate inhibits microbial growth for up to 12 hours, as demonstrated by test data for representative USP microorganisms.

Guidelines for Aseptic Technique for General Anesthesia/MAC Sedation

Propofol Injectable Emulsion must be prepared for use just prior to initiation of each individual anesthetic/sedative procedure. The vial rubber stopper should be disinfected using 70% isopropyl alcohol. Propofol Injectable Emulsion should be drawn into a sterile syringe immediately after a vial is opened. When withdrawing Propofol Injectable Emulsion from vials, a sterile vent spike should be used. The syringe should be labeled with appropriate information including the date and time the vial was opened. Administration should commence promptly and be completed within 12 hours after the vial has been opened.

Propofol Injectable Emulsion must be prepared for single‑patient use only. Any unused Propofol Injectable Emulsion drug product, reservoirs, dedicated administration tubing and/or solutions containing Propofol Injectable Emulsion must be discarded at the end of the anesthetic procedure or at 12 hours, whichever occurs sooner. The IV line should be flushed every 12 hours and at the end of the anesthetic procedure to remove residual Propofol Injectable Emulsion.

Guidelines for Aseptic Technique for ICU Sedation

Propofol Injectable Emulsion must be prepared for single-patient use only. Strict aseptic techniques must be followed. The vial rubber stopper should be disinfected using 70% isopropyl alcohol. A sterile vent spike and sterile tubing must be used for administration of Propofol Injectable Emulsion. As with other lipid emulsions, the number of IV line manipulations should be minimized. Administration should commence promptly and must be completed within 12 hours after the vial has been spiked. The tubing and any unused Propofol Injectable Emulsion drug product must be discarded after 12 hours.

If Propofol Injectable Emulsion is transferred to a syringe prior to administration, it should be drawn into a sterile syringe immediately after a vial is opened. When withdrawing Propofol Injectable Emulsion from a vial, a sterile vent spike should be used. The syringe should be labeled with appropriate information including the date and time the vial was opened. Administration should commence promptly and be completed within 12 hours after the vial has been opened. Propofol Injectable Emulsion should be discarded and administration lines changed after 12 hours.

HOW SUPPLIED

Propofol Injectable Emulsion USP is available as follows:

NDC No.

Strength

0591-2136-95

1% (10 mg/mL propofol)

20 mL ready-to-use single-patient infusion vials in packages of twenty five.

0591-2136-51

1% (10 mg/mL propofol)

50 mL ready-to-use single-patient infusion vials in packages of twenty.

0591-2136-68

1% (10 mg/mL propofol)

100 mL ready-to-use single-patient infusion vials in packages of ten.

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.

ANIMAL TOXICOLOGY AND/OR PHARMACOLOGY

Published studies in animals demonstrate that the use of anesthetic agents during the period of rapid brain growth or synaptogenesis results in widespread neuronal and oligodendrocyte cell loss in the developing brain and alterations in synaptic morphology and neurogenesis. Based on comparisons across species, the window of vulnerability to these changes is believed to correlate with exposures in the third trimester through the first several months of life, but may extend out to approximately 3 years of age in humans.

In primates, exposure to 3 hours of an anesthetic regimen that produced a light surgical plane of anesthesia did not increase neuronal cell loss, however, treatment regimens of 5 hours or longer increased neuronal cell loss. Data in rodents and in primates suggest that the neuronal and oligodendrocyte cell losses are associated with subtle but prolonged cognitive deficits in learning and memory. The clinical significance of these nonclinical findings is not known, and healthcare providers should balance the benefits of appropriate anesthesia in neonates and young children who require procedures against the potential risks suggested by the nonclinical data (see WARNINGS, Pediatric Neurotoxicity, PRECAUTIONS; Pregnancy, Pediatric Use).

Manufactured In Italy by:

Corden Pharma

Caponago, Italy 20867

Distributed by:

Actavis Pharma, Inc.

Parsippany, NJ 07054 USA


Rev. A 2/2020

PRINCIPAL DISPLAY PANEL

NDC 0591-2136 -95

Sterile, nonpyrogenic

Propofol Injectable Emulsion, USP

200 mg per 20 mL

(10 mg per mL)

For Intravenous Administration

SHAKE WELL BEFORE USING

• Use strict aseptic technique

• Contains sodium benzoate, which inhibits microbial growth up to 12 hours

• Discard within 12 hours of entering the vial

Twenty-five 20 mL

Vials for Single Patient Use Only

Rx Only

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PROPOFOL
propofol injection, emulsion
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-2136
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROPOFOL (PROPOFOL) PROPOFOL 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SOYBEAN OIL 100 mg in 1 mL
GLYCERIN 22.5 mg in 1 mL
EGG PHOSPHOLIPIDS 12 mg in 1 mL
SODIUM BENZOATE
SODIUM HYDROXIDE
Product Characteristics
Color WHITE (White to almost white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-2136-51 20 VIAL in 1 CARTON contains a VIAL (0591-2136-55)
1 NDC:0591-2136-55 50 mL in 1 VIAL This package is contained within the CARTON (0591-2136-51)
2 NDC:0591-2136-68 10 VIAL in 1 CARTON contains a VIAL (0591-2136-57)
2 NDC:0591-2136-57 100 mL in 1 VIAL This package is contained within the CARTON (0591-2136-68)
3 NDC:0591-2136-95 25 VIAL in 1 CARTON contains a VIAL (0591-2136-80)
3 NDC:0591-2136-80 20 mL in 1 VIAL This package is contained within the CARTON (0591-2136-95)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205307 01/07/2016
Labeler — Actavis Pharma, Inc. (119723554)

Revised: 02/2020 Actavis Pharma, Inc.

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