PROPOFOL injection, emulsion

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

HF Acquisition Co LLC, DBA HealthFirst

Администрация маршрут:

INTRAVENOUS

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Propofol injectable emulsion is an IV general anesthetic and sedation drug that can be used as described in the table below. TABLE 3. INDICATIONS FOR PROPOFOL INJECTABLE EMULSION 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 emuls

Обзор продуктов:

PROPOFOL INJECTION EMULSION is supplied in the following dosage forms. NDC 51662-1293-1 PROPOFOL INJECTION EMULSION 200mg/20mL (10mg/mL) VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Propofol injectable emulsion is supplied in ready-to-use vials containing 10 mg/mL of propofol as follows: Propofol undergoes oxidative degradation, in the presence of oxygen, and is therefore packaged under nitrogen to eliminate this degradation path. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature]. 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.

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

PROPOFOL- PROPOFOL INJECTION, EMULSION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
----------
PROPOFOL INJECTION EMULSION 200MG/20ML (10MG/ML) VIAL
SPL UNCLASSIFIED
Rx only
CONTAINS BENZYL ALCOHOL (see PRECAUTIONS)
Fliptop Vial
FOR INTRAVENOUS ADMINISTRATION
Shake Well Before Use
Strict aseptic technique must always be maintained during handling.
Propofol injectable
emulsion is a single access parenteral product (single patient
infusion vial) which
contains benzyl alcohol 1.5 mg/mL and sodium benzoate 0.7 mg/mL 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.
Accordingly, strict aseptic technique must still be adhered to. 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 is a sterile, nonpyrogenic emulsion
containing 10 mg/mL of
propofol suitable for intravenous administration. Propofol is
chemically described as 2,6-
diisopropylphenol. The structural formula is:
C
H
O M.W. 178.27
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