ANESTHESIA S/I-60- propofol, sterile isopropyl alcohol kit

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

RX PHARMA-PACK, INC.

INN (International Name):

PROPOFOL

Sammensetning:

PROPOFOL 10 mg in 1 mL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

DIPRIVAN is an IV general anesthetic and sedation drug that can be used as described in the table below. Table 3.  Indications for DIPRIVAN Safety, effectiveness and dosing guidelines for DIPRIVAN have not been established for MAC Sedation in the pediatric population; therefore, it is not recommended for this use (see PRECAUTIONS, Pediatric Use ). DIPRIVAN 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), DIPRIVAN 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. DIPRIVAN is not indicated for use in Pediatric ICU sedation since the safety of this regimen has not been established (see PR

Produkt oppsummering:

DIPRIVAN (propofol) Injectable Emulsion, USP Vials 10 mL ready-to-use single- patient infusion vial in packages of ten.  20 mL ready-to-use single- patient infusion vial in packages of ten.  50 mL ready-to-use single- patient infusion vial in packages of twenty.  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. All trademarks are the property of Fresenius Kabi USA, LLC. Manufactured for: Fresenius Kabi Logo Lake Zurich, IL 60047 www.fresenius-kabi.com/us Revised: December 2017

Autorisasjon status:

New Drug Application

Preparatomtale

ANESTHESIA S/I-60- PROPOFOL, STERILE ISOPROPYL ALCOHOL
RX PHARMA-PACK, INC.
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ANESTHESIA S-I-60
DIPRIVAN - PROPOFOL INJECTION, EMULSION
DIPRIVAN INJECTABLE EMULSION, USP
10 MG PER ML
FRESENIUS KABI USA, LLC
FOR INTRAVENOUS ADMINISTRATION
_Strict aseptic technique must always be maintained during handling.
DIPRIVAN is a single access_
_parenteral product (single patient infusion vial) which contains
0.005% disodium edetate (EDTA) to inhibit_
_the rate of growth of microorganisms, for up to 12 hours, in the
event of accidental extrinsic contamination._
_However, DIPRIVAN can still support the growth of microorganisms, as
it is not an antimicrobially_
_preserved product under USP standards. 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 DIPRIVAN 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. DIPRIVAN 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
DIPRIVAN (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:
DIPRIVAN STRUCTURAL FORMULA
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
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