PROPOFOL injection, emulsion

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Civica, Inc.

Droga podania:

INTRAVENOUS

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Propofol injectable emulsion is an IV general anesthetic and sedation drug that can be used as described in the table below. Indication Approved Patient Population Safety, effectiveness and dosing guidelines for propofol have not been established for MAC Sedation in the pediatric population; therefore, it is not recommended for this use. (See PRECAUTIONS - Pediatric use . ) Propofol 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 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 is not indicated for use in Pediatric ICU sedation since the safety of this regimen has

Podsumowanie produktu:

Propofol Injectable Emulsion , USP Vials containing 10 mg/mL of propofol, is available as follows: 20 mL single dose vial in cartons of 10. NDC 72572-583-10 . 50 mL single-patient infusion vial in cartons of 20. NDC 72572-584-20 . 100 mL single-patient infusion vial in cartons of 10. NDC  72572-585-10 . Propofol undergoes oxidative degradation, in the presence of oxygen, and is therefore packaged under nitrogen to eliminate this degradation path. Store between 4° to 25°C (40° to 77°F). DO NOT FREEZE. Shake well before use.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

PROPOFOL- PROPOFOL INJECTION, EMULSION
CIVICA, INC.
----------
PROPOFOL INJECTABLE EMULSION, USP
CONTAINS BENZYL ALCOHOL (SEE PRECAUTIONS SECTION)
FOR IV ADMINISTRATION
RX ONLY
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 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 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 shown below:
Molecular Formula: C
H
0
Molecular Weight: 178.27
Propofol is slightly soluble in water and, thus, is formulated in a
white, oil-in-water
12
18
emulsion. The pKa is 11. The octanol/water partition coefficient for
propofol is 6761:1 at
a pH of 6 to 8.5. Each mL of Propofol Injectable Emulsion con