PROPOFOL injection emulsion

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

APP Pharmaceuticals, LLC

INN (Mezinárodní Name):

PROPOFOL

Složení:

PROPOFOL 10 mg in 1 mL

Druh předpisu:

PRESCRIPTION DRUG

Stav Autorizace:

New Drug Application

Charakteristika produktu

PROPOFOL- PROPOFOL INJECTION, EMULSION
APP PHARMACEUTICALS, 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