PROPOFOL- propofol injection, emulsion

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

PROPOFOL (UNII: YI7VU623SF) (PROPOFOL - UNII:YI7VU623SF)

Disponibbli minn:

General Injectables and Vaccines, Inc.

Rotta amministrattiva:

INTRAVENOUS

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Propofol Injectable Emulsion is an IV general anesthetic and sedation drug that can be used as described in the table below. Safety, effectiveness and dosing guidelines for Propofol 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). Propofol 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), Propofol Injectable Emulsion can be administered to intubated, mechanically ventilated adult patients to procide 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. Propofol Injectable Emulsion is not indicated for use in Pediatric ICU sedation si

Sommarju tal-prodott:

Propofol 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. 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.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

PROPOFOL- PROPOFOL INJECTION, EMULSION
GENERAL INJECTABLES AND VACCINES, INC.
----------
PROPOFOL
10 MG PER ML
FOR INTRAVENOUS ADMINISTRATION
_Strict aseptic technique must alwasy 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, for up to 12 hours, in the event of
accidental exxtrinsic 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._
(See WARNINGS and DOSAGE AND ADMINISTRATION, HANDLING PROCEDURES).
DESCRIPTION
Propofol Injectable Emulsion, USP is a white or almost white sterile,
nonpyrogenic homogenous
emulsion containing 10 mg/mL of propofol suitable for intravenous
administration. Propofol is
chemically described as 2,6-diisopropylphenol. The structural formula
is:
Propofol is slightly soluble in water and, thus, is formulated in a
white, oil-in-water emulsion. The pKa
is 11. The octanol/water partition coefficient for propofol is 6761:1
at a pH of 6 to 8.5. In addition to
the active component, propofol, the formulation also contains soybean
oil (100 mg/mL), glycerin (22.5
mg/mL), egg ph