Anesthesia S / I-50

FOR INTRAVENOUS ADMINISTRATION

Rx Only

Strict aseptic technique must always be maintained during handling. DIPRIVAN Injectable Emulsion is a single access parenteral product (single patient infusion vial) which contains 0.005% disodium edetate (EDTA) to inhibit the rate of growth of microorganisms, for up to 12 hours, in the event of accidental extrinsic contamination. However, DIPRIVAN 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 DIPRIVAN Injectable Emulsion was associated with microbial contamination of the product and with fever, infection/sepsis, other lifethreatening 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. DIPRIVAN Injectable Emulsion vials are never to be accessed more than once or used on more than one person.

(See WARNINGS and DOSAGE AND ADMINISTRATION, Handling Procedures).

DIPRIVAN Injectable Emulsion is an IV sedative-hypnotic agent that can be used as described in the table below. 

                                                      Table 3.  Indications for DIPRIVAN Injectable Emulsion

Safety, effectiveness and dosing guidelines for DIPRIVAN Injectable Emulsion have not been established for MAC Sedation in the pediatric population; therefore, it is not recommended for this use (see PRECAUTIONS, Pediatric Use). 

DIPRIVAN Injectable Emulsion 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. 

In the Intensive Care Unit (ICU), DIPRIVAN Injectable Emulsion can be administered to intubated, mechanically ventilated adult patients to provide continuous sedation and control of stress responses only by persons skilled in the medical management of critically ill patients and trained in cardiovascular resuscitation and airway management. 

DIPRIVAN Injectable Emulsion is not indicated for use in Pediatric ICU sedation since the safety of this regimen has not been established (see PRECAUTIONS, Pediatric Use). 

DIPRIVAN Injectable Emulsion is not recommended for obstetrics, including Cesarean section deliveries.  DIPRIVAN Injectable Emulsion crosses the placenta, and as with other general anesthetic agents, the administration of DIPRIVAN Injectable Emulsion may be associated with neonatal depression (see PRECAUTIONS). 

DIPRIVAN Injectable Emulsion is not recommended for use in nursing mothers because propofol has been reported to be excreted in human milk, and the effects of oral absorption of small amounts of propofol are not known (see PRECAUTIONS).

Use of DIPRIVAN Injectable Emulsion has been associated with both fatal and life-threatening anaphylactic and anaphylactoid reactions. 

For general anesthesia or monitored anesthesia care (MAC) sedation, DIPRIVAN Injectable Emulsion should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure.  Sedated patients should be continuously monitored, and facilities for maintenance of a patent airway, providing artificial ventilation, administering supplemental oxygen, and instituting cardiovascular resuscitation must be immediately available.  Patients should be continuously monitored for early signs of hypotension, apnea, airway obstruction, and/or oxygen desaturation.  These cardiorespiratory effects are more likely to occur following rapid bolus administration, especially in the elderly, debilitated, or ASA-PS III or IV patients. 

For sedation of intubated, mechanically ventilated patients in the Intensive Care Unit (ICU), DIPRIVAN Injectable Emulsion should be administered only by persons skilled in the management of critically ill patients and trained in cardiovascular resuscitation and airway management.

Use of DIPRIVAN Injectable Emulsion infusions for both adult and pediatric ICU sedation has been associated with a constellation of metabolic derangements and organ system failures, referred to as Propofol Infusion Syndrome, that have resulted in death.  The syndrome is characterized by severe metabolic acidosis, hyperkalemia, lipemia, rhabdomyolysis, hepatomegaly, renal failure, ECG changes* and/or cardiac failure.  The following appear to be major risk factors for the development of these events: decreased oxygen delivery to tissues; serious neurological injury and/or sepsis; high dosages of one or more of the following pharmacological agents: vasoconstrictors, steroids, inotropes and/or prolonged, high-dose infusions of propofol (> 5 mg/kg/h for > 48h).  The syndrome has also been reported following large-dose, short-term infusions during surgical anesthesia.  In the setting of prolonged need for sedation, increasing propofol dose requirements to maintain a constant level of sedation, or onset of metabolic acidosis during administration of a propofol infusion, consideration should be given to using alternative means of sedation.

*Coved ST segment elevation (similar to ECG changes of the Brugada syndrome).

Abrupt discontinuation of DIPRIVAN Injectable Emulsion prior to weaning or for daily evaluation of sedation levels should be avoided.  This may result in rapid awakening with associated anxiety, agitation, and resistance to mechanical ventilation.  Infusions of DIPRIVAN Injectable Emulsion should be adjusted to maintain a light level of sedation through the weaning process or evaluation of sedation level (see PRECAUTIONS). 

DIPRIVAN Injectable Emulsion should not be coadministered through the same IV catheter with blood or plasma because compatibility has not been established.  In vitro tests have shown that aggregates of the globular component of the emulsion vehicle have occurred with blood/plasma/serum from humans and animals.  The clinical significance of these findings is not known. 

There have been reports in which failure to use aseptic technique when handling Diprivan Injectable Emulsion was associated with microbial contamination of the product and with fever, infection, sepsis, other life-threatening illness, and death.  Do not use if contamination is suspected.  Discard unused drug product as directed within the required time limits (see DOSAGE AND ADMINISTRATION, Handling Procedures ).

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.  DIPRIVAN Injectable Emulsion vial is never to be accessed more than once or used on more than one person.

There are reports of the abuse of propofol for recreational and other improper purposes, which have resulted in fatalities and other injuries. Instances of self-administration of DIPRIVAN Injectable Emulsion by health care professionals have also been reported, which have resulted in fatalities and other injuries.  Inventories ofDIPRIVAN Injectable Emulsion should be stored and managed to prevent the risk of diversion, including restriction of access and accounting procedures as appropriate to the clinical setting.

DIPRIVAN Injectable Emulsion, USP is available as follows:

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. 

• Water
  

NDC 63323-269-59         PRX260950

DIPRIVAN®

 (Propofol)        INJECTABLE
                         EMULSION, USP

500 mg per 50 mL
(10 mg per mL)

FOR INTRAVENOUS ADMINISTRATION
50 mL - For Single Patient Use Only

Sterile, nonpyrogenic

SHAKE WELL BEFORE USING

Dosage: See package insert.
Store between 4º to 25ºC (40º to 77ºF).
Do not freeze

Rx only

Manufactured for:
Fresenius Kabi USA, LLC
Lake Zurich, IL 60047

Made in Austria   

US Pat   5,714,520    5,731,355

              5,731,356     5,908,869

402877A
M091093/01 US

Diprivan

NDC# 67777-121-13

Made in India

dynarex

Sterile Alcohol Prep Pad

For External Use Only
Apply topically as needed
Discard after single use
Sterile Solution
Sterile unless pouch is
opened or damaged

Not made with natural rubber latex

1 Pad Medium

Sterile Alcohol Prep Pad
For external Use Only

Contents: One Prep Pad saturated with 70% isopropyl alcohol.

See box for complete drug facts

Manufactured for:
Dynarex Corporation
Orangeburg, NY 10962
www.dynarex.com

Alcohol Prep Pad