INTRALIPID soybean oil emulsion

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Vedd Meg Most

Letöltés Termékjellemzők (SPC)
09-01-2018

Aktív összetevők:

SOYBEAN OIL (UNII: 241ATL177A) (SOYBEAN OIL - UNII:241ATL177A)

Beszerezhető a:

Baxter Healthcare Corporation

INN (nemzetközi neve):

SOYBEAN OIL

Összetétel:

SOYBEAN OIL 30 g in 100 mL

Recept típusa:

PRESCRIPTION DRUG

Engedélyezési státusz:

New Drug Application

Termékjellemzők

                                INTRALIPID- SOYBEAN OIL EMULSION
BAXTER HEALTHCARE CORPORATION
----------
INTRALIPID 30%
A 30% I.V. Fat Emulsion in Excel
Container
PHARMACY BULK PACKAGE
NOT FOR DIRECT INFUSION
DESCRIPTION
Intralipid
30% (A 30% I.V. Fat Emulsion) Pharmacy Bulk Package is a sterile,
non-pyrogenic fat
emulsion intended as a source of calories and essential fatty acids
for use in a pharmacy admixture
program. It is made up of 30% Soybean Oil, 1.2% Egg Yolk
Phospholipids, 1.7% Glycerin, and Water
for Injection. In addition, sodium hydroxide has been added to adjust
the pH so that the final product pH
is 8. pH range is 6 to 8.9.
INTRALIPID 30% PHARMACY BULK PACKAGE IS NOT INTENDED FOR DIRECT
INFUSION. IT IS A STERILE DOSAGE
FORM WHICH CONTAINS SEVERAL SINGLE DOSES FOR USE IN THE PREPARATION OF
THREE-IN-ONE OR TOTAL
NUTRIENT ADMIXTURES (TNAS) IN A PHARMACY ADMIXTURE PROGRAM.
The soybean oil is a refined natural product consisting of a mixture
of neutral triglycerides of
predominantly unsaturated fatty acids with the following structure:
where
-,
- and
- are saturated and unsaturated fatty acid residues.
The major component fatty acids are linoleic (44-62%), oleic (19-30%),
palmitic (7-14%), linolenic (4-
11%) and stearic (1.4-5.5%) . These fatty acids have the following
chemical and structural formulas:
Linoleic acid
C
H O
Oleic acid
C
H O
Palmitic acid
C
H O
®
®
®
®
1
18
32
2
18
34
2
16
32
2
Linolenic acid
C
H O
Stearic acid
C
H O
Purified egg phosphatides are a mixture of naturally occurring
phospholipids which are isolated from
the egg yolk. These phospholipids have the following general
structure:
- and
contain saturated and unsaturated fatty acids that abound in neutral
fats. R primarily either
the choline or the ethanolamine ester of phosphoric acid.
Phosphatidylcholine
Phosphatidylethanolamine
Glycerin is chemically designated C H O and is a clear colorless,
hygroscopic syrupy liquid. It has
the following structural formula:
Intralipid
30% (A 30% I.V. Fat Emulsion) has an osmolality of approximately 310
mOsmoL/kg water
(whi
                                
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