Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
PROPOFOL (UNII: YI7VU623SF) (PROPOFOL - UNII:YI7VU623SF)
General Injectables and Vaccines, Inc
PROPOFOL
PROPOFOL 10 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
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 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 sin
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.
Abbreviated New Drug Application
PROPOFOL- PROPOFOL INJECTION, EMULSION GENERAL INJECTABLES AND VACCINES, INC ---------- PROPOFOL INJECTABLE EMULSION PAA 109887 PROPOFOL Injectable Emulsion 10 MG/ML CONTAINS BENZYL ALCOHOL (SEE PRECAUTIONS) Rx only Fliptop Vial FOR INTRAVENOUS ADMINISTRATION SHAKE WELL BEFORE USE PAA 109887 _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 injection 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: Propofol is slightly soluble in water and, thus, is formulated in a white, oil-in-water emulsion. The pKa is 11. Belgenin tamamını okuyun