PROPOFOL injection, emulsion

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

General Injectables & Vaccines, Inc.

Via de administração:

INTRAVENOUS

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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 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. Propofol Injectable Emulsion is not indicated for use in Pediatric ICU sedation

Resumo do produto:

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. 

Status de autorização:

Abbreviated New Drug Application

Características técnicas

PROPOFOL- PROPOFOL INJECTION, EMULSION
GENERAL INJECTABLES & VACCINES, INC.
----------
PROPOFOL INJECTABLE EMULSION, USP
RX ONLY
10 MG PER ML
62000043-AW V.1
REF.: D300.053/A F50
10 MG PER ML
FOR INTRAVENOUS ADMINISTRATION
_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,
for 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._
_(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, prop