PROPOFOL injection emulsion

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Fresenius Kabi USA, LLC

INN (Algemene Internationale Benaming):

PROPOFOL

Samenstelling:

PROPOFOL 10 mg in 1 mL

Prescription-type:

PRESCRIPTION DRUG

Autorisatie-status:

New Drug Application

Productkenmerken

PROPOFOL- PROPOFOL INJECTION, EMULSION
FRESENIUS KABI USA, LLC
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PROPOFOL INJECTABLE EMULSION, USP
FOR IV ADMINISTRATION
Rx only
Strict aseptic technique must always be maintained during handling.
Propofol Injectable Emulsion is a
single-use parenteral product which contains 0.005% disodium edetate
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 portions as directed within the
required time limits (see DOSAGE AND ADMINISTRATION, _HANDLING
PROCEDURES_). 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.
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:
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 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), glycerol (22.5
mg/mL), egg lecithin (12 mg/mL); and disodium edetate (0.005%); with
sodium hydroxide to adjust pH.
The Propofol Injectable Emulsion, USP is isotonic and has a pH of 7 to
8.5.
CLINICAL PHARMACOLOGY
GENERAL
Propofol Injectable Emulsion is an intravenous sedative-hypnotic agent
for use in the induction and
maintenance of anesthesia or sedation. Intravenous injection of a
therapeutic dose of propofol induces