PROPOFOL injection, emulsion

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

HF Acquisition Co LLC, DBA HealthFirst

Pot uporabe:

INTRAVENOUS

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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

Povzetek izdelek:

PROPOFOL INJECTABLE EMULSION is supplied in the following dosage forms. NDC 51662-1471-1 PROPOFOL INJECTABLE EMULSION 500mg/50mL (10mg/mL) 50mLVIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Propofol Injectable Emulsion, USP is supplied 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.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

PROPOFOL- PROPOFOL INJECTION, EMULSION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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PROPOFOL INJECTABLE EMULSION 500MG/50ML (10MG/ML) 50MLVIAL
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, USP
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, USP 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:
Propofol, USP is slightly soluble in water and, thus, is formulated in
a white, oil-in-water emulsion.
The pKa is 11. The octanol/water partit