Fat Emulsion 10% 250ml soybean oil, egg lecithin and glycerol
provide calories,energy,certain nutrient
10% Intravenous Fat Emulsion is a sterile, non-pyrogenic fat
emulsion prepared for intravenous administration as a source of
calories and essential fatty acids. It is made up of 10% Soybean
Oil, 1.2% Egg Yolk Phospholipids, 2.25% 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.
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%)1. These fatty acids have the following chemical and
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. R3 is primarily either the choline or ethanolamine
ester of phosphoric acid.
Glycerin is chemically designated C3H8O3 and is a clear colorless,
hygroscopic syrupy liquid. It has the following structural formula:
10% Intravenous Fat Emulsion has an osmolality of approximately 300
mOsmol/kg water (which represents 260 mOsmol/liter of emulsion) and
contains emulsified fat particles of approximately 0.5 micron size.
The total caloric value, including fat, phospholipid and glycerin,
is 1.1 kcal per mL of Intralipid 10%. The phospholipids present
contribute 47 milligrams or approximately 1.5 mmol of phosphorus
per 100 mL, of the emulsion.
10% Intravenous Fat Emulsion is metabolized and utilized as a
source of energy causing an increase in heat production, decrease
in respiratory quotient and increase in oxygen consumption. The
infused fat particles are cleared from the blood stream in a manner
thought to be comparable to the clearing of chylomicrons.
10% Intravenous Fat Emulsion will prevent the biochemical lesions
of essential fatty acid deficiency (EFAD), and correct the clinical
manifestations of the EFAD syndrome.
INDICATIONS AND USAGE
10% Intravenous Fat Emulsion is indicated as a source of calories
and essential fatty acids for patients requiring parenteral
nutrition for extended periods of time (usually for more than 5
days) and as a source of essential fatty acids for prevention of
The administration of 10% Intravenous Fat Emulsion is
contraindicated in patients with disturbances of normal fat
metabolism such as pathologic hyperlipemia, lipoid nephrosis or
acute pancreatitis if accompanied by hyperlipidemia.
Caution should be exercised in administering
10% Intravenous Fat Emulsion to patients with severe liver damage,
pulmonary disease, anemia or blood coagulation disorders, or when
there is danger of fat embolism.
This product contains aluminum that may be toxic. Aluminum may
reach toxic levels with prolonged parenteral administration if
kidney function is impaired. Premature neonates are particularly at
risk because their kidneys are immature, and they require large
amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function,
including premature neonates, who receive parenteral levels of
aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at
levels associated with central nervous system and bone toxicity.
Tissue loading may occur at even lower rates of administration.
When 10% Intravenous Fat Emulsion is administered, the patients
capacity to eliminate the infused fat from the circulation must be
monitored by use of an appropriate laboratory determination of
serum triglycerides. Overdosage must be avoided.
During long term intravenous nutrition with Intralipid® 10%, liver
function tests should be performed. If these tests indicate that
liver function is impaired, the therapy should be withdrawn.
Frequent (some advise daily) platelet counts should be done in
neonatal patients receiving parenteral nutrition with 10%
Intravenous Fat Emulsion .
Drug product contains no more than 25 mcg/L of aluminum.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Studies with Intralipid® have not been performed to evaluate
carcinogenic potential, mutagenic potential, or effects on
Pregnancy Category C:
Animal reproduction studies have not been conducted with
Intralipid®. It is also not known whether 10% Intravenous Fat
Emulsion can cause fetal harm when administered to a pregnant woman
or can affect reproduction capacity. 10% Intravenous Fat Emulsion
should be given to a pregnant woman only if clearly needed.
Caution should be exercised when 10% Intravenous Fat Emulsion is
administered to a nursing woman.
Pediatric Use: See DOSAGE AND ADMINISTRATION.
AVOID OVERDOSAGE ABSOLUTELY.
The adverse reactions observed can be separated into two classes:
- Those more frequently encountered are due: either to contamination
of the intravenous catheter and result in sepsis, or to vein
irritation by concurrently infused hypertonic solutions and may
result in thrombophlebitis. These adverse reactions are inseparable
from the hyper-alimentation procedure with or without 10% I.V. Fat
- Less frequent reactions more directly related to 10% Intravenous
Fat Emulsion are: a) immediate or early adverse reactions, each of
which has been reported to occur in clinical trials, in an
incidence of less than 1 %; dyspnea, cyanosis, allergic reactions,
hyperlipemia, hypercoagulability, nausea, vomiting, headache,
flush-ing, increase in temperature, sweating, sleepiness, pain in
the chest and back, slight pressure over the eyes, dizziness, and
irritation at the site of infusion, and, rarely, thrombocytopenia
in neonates; b) delayed adverse reactions such as hepatomegaly,
jaundice due to central lobular cholestasis, splenomegaly,
thrombocytopenia, leukopenia, transient increases in liver function
tests, and overloading syndrome (focal seizures, fever,
leukocytosis, hepatomegaly, splenomegaly and shock).
The deposition of a brown pigmentation in the reticuloendothelial
system, the so-called ” intravenous fat pigment,” has been reported
in patients infused with 10% Intravenous Fat Emulsion . The causes
and significance of this phenomenon are unknown.
In the event of fat overload during therapy, stop the infusion of
10% Intravenous Fat Emulsion until visual inspection of the plasma,
determination of triglyceride concentrations, or measurement of
plasma light-scattering activity by nephelometry indicates the
lipid has cleared. Re-evaluate the patient and institute
appropriate corrective measures. See WARNINGS and PRECAUTIONS.
Principal Display Panel - Bag Label
10% I.V. Fat Emulsion
For Intravenous Use
Each 100 mL contains:
Soybean Oil 10.0 g
Phospholipids (from powdered egg yolk) 1.2 g
Glycerin, USP 2.25 g
Water for Injection q.s.
Calories 110 kcal
pH 8.0 (6.0-8.9) adjusted with sodium hydroxide.
Use only if bag and seal are undamaged. Administer intravenously.
Do not add medications to this emulsion. Contains no more than 25
μg/L of aluminum.
Sterile-Nonpyrogenic. See Directions Before Using. Single Dose
Container. Do not store
above 25°C (77°F). Do not freeze 10% Intravenous Fat Emulsion ; If accidentally
frozen, discard the bag.