Active substance(s): SOYBEAN OIL PURIFIED
Emulsion for infusion
Qualitative and quantitative composition
1000 ml of the emulsion contains:
Purified soybean oil
Organic phosphate content:
For excipients, see list of excipients
310 mosm/kg water
12.6 MJ (3000 kcal) / 1000 ml
15 mmol/1000 ml
Emulsion for infusion.
White homogenous emulsion.
INTRALIPID is indicated in patients needing intravenous nutrition
to supply energy and essential fatty acids. INTRALIPID is also
indicated in patients with essential fatty acid
deficiency (EFAD) who cannot maintain or restore a normal
essential fatty acid pattern by oral intake.
Posology and method of administration
The ability to eliminate INTRALIPID should govern the dosage and
infusion rate. See below Fat elimination.
1g triglycerides corresponds to 3,33 ml INTRALIPID 30%.
The recommended maximum dosage is 3 g triglycerides/ kg body
weight/day. Within this upper limit, INTRALIPID can be given to
contribute up to 70% of the energy requirements, also in patients
with highly increased energy requirements. The infusion rate for
INTRALIPID 30% should not exceed 333 ml in 5 hours.
Essential fatty acid deficiency (EFAD). To prevent or correct
essential fatty acid deficiency, 4 to 8% of the nonprotein energy
should be supplied as INTRALIPID to provide suffi cient amounts
of linoleic and linolenic acid. When EFAD is associated with stress,
the amount of INTRALIPID needed to correct the deficiency may
be substantially increased.
Pregnancy and lactation
The ability to eliminate fat should be closely monitored in patients
with conditions mentioned in section “Special warnings and special
precautions for use”, and in patients given Intralipid for more than
one week. This is done by collecting a blood sample after a fatfree clearance period of 5-6 hours. Blood cells are then separated
from plasma by centrifugation. If the plasma is opalescent, the
infusion should be postponed. The sensitivity of this method is
such that hypertriglyceridaemia can pass undetected. Therefore,
it is recommended that serum triglyceride concentrations should
be measured in patients who are likely to have impaired fat
Experience from INTRALIPID 30% during pregnancy and lactation
is lacking, but theoretically INTRALIPID 30% is expected to be
tolerated similarly to INTRALIPID 10% and 20% where no adverse
reactions connected with pregnancy and lactation have been
reported. Animal reproduction studies have not been carried out
with INTRALIPID 30%.
INTRALIPID is contraindicated in patients with acute shock and
in patients with severe hyperlipemia. Severe liver insufficiency.
Hemophagocytotic syndrome. Hypersensitivity to egg-, soya- or
peanut protein or to any of the active substances or excipients.
Special warnings and special precautions for use
INTRALIPID should be given with caution in conditions of impaired
lipid metabolism as in renal insufficiency, uncompensated diabetes
mellitus, pancreatitis, impaired liver function, hypothyroidism (if
hypertri-glyceridemic) and sepsis. If INTRALIPID is given to patients
with these conditions, close monitoring of the serum triglyceride
concentration is obligatory.
This medicinal product contains soya-bean oil and egg
phospholipids, which may rarely cause allergic reactions. Cross
allergic reactions have been observed between soybean and
INTRALIPID may interfere with certain laboratory measurements
(bilirubin, lactate dehydrogenase, oxygen saturation, Hb etc) if
blood is sampled before fat has been adequately cleared from the
blood stream. Fat is cleared after a fat free interval of 5-6 hours
in most patients.
Interaction with other medicaments and other forms of
Some drugs, like insulin, may interfere with the body’s lipase
system. This kind of interaction seems, however, to be of only
limited clinical importance.
Heparin in clinical doses causes a transient increase in lipolysis in
plasma, resulting in a transient decrease in triglyceride clearance
due to depletion of lipoprotein lipase.
Soybean oil has a natural content of vitamin K1. This is considered
important only for patients treated with coumarin derivatives,
which interfere with vitamin K1.
Effects on ability to drive and use machines
No effects on the ability to drive and operate machines are to be
INTRALIPID infusion may cause a rise in body temperature and, less
frequently, shivering, chills and nausea/vomiting (incidence<1%).
Reports of other adverse events in conjunction with INTRALIPID
infusion are extremely rare, less than one adverse event per one
System Organ Class
according to WHO
Body as a whole general Uncommon
Cardiovascular disorders Very rare
Gastrointestinal disorders Uncommon
Liver & biliary system
connective tissue and
Platelet, bleeding &
Red blood cell disorders Very rare
Reproductive disorders, Very rare
Skin and appendages
Trombocytopenia has been reported in association with prolonged
treatment with INTRALIPID in infants.
Transient increase in liver function tests after prolonged
intravenous nutrition with or without INTRALIPID have also been
noted. The reasons are not clear at present.
Both the elimination and the oxidation rates are dependent on
the patient’s clinical condition; elimination is faster and utilisation
is increased in postoperative patients and in trauma, while patients
with renal failure and hypertriglyceridaemia show lower utilisation
of exogenous fat emulsions.
Fat overload syndrome. An impaired capacity to eliminate
INTRALIPID may lead to the fat overload syndrome as a
result of overdosage. However, this syndrome may appear
also at recommended rates of infusion in association with a
sudden change in the patient’s clinical condition, such as renal
function impairment or infection. The fat overload syndrome is
characterised by hyperlipemia, fever, fat infiltration and disorders
in various organs and coma. All symptoms are usually reversible if
the infusion of INTRALIPID is discontinued.
See Undesirable effects, “Fat overload syndrome”. Severe
overdose of fat emulsions containing triglycerides can, especially
if carbohydrates are not administered simultaneously, lead to
Rise in body
in liver function
INTRALIPID is eliminated from the circulation via the same
pathway as endogenous chylomicrons, at least early on in the
catabolism. The exogenous fat particle is hydrolysed in the
circulation and taken up by LDL receptors peripherally and by the
liver. The elimination rate is determined by the composition of
the fat particles, the nutritional status, the disease and the rate
of infusion. In healthy volunteers the maximum clearance rate of
INTRALIPID after fasting overnight is equivalent to 3.8+1.5 g of
triglycerides/kg body weight/24 hours.
Intralipid provides essential and non-essential long-chain fatty
acids for energy metabolism and apposition in cell membranes.
Intralipid in the recommended dosage does not cause any
haemodynamic changes. No clinically significant changes in
pulmonary function have been described when INTRALIPID is
used properly. The transient increase in liver enzymes seen in
some patients on TPN including INTRALIPID is reversible and
disappears when TPN is interrupted. Similar changes are seen also
in parenteral nutrition without fat emulsions.
INTRALIPID has biological properties similar to those of endogenous
chylomicrons. Unlike chylomicrons, INTRALIPID does not contain
cholesterol esters or apolipoproteins, while its phospholipid
content is significantly higher.
List of excipients
Purified egg phospholipids
Water for injections
INTRALIPID can only be mixed with other medicinal products for
which compatibility has been documented.
Shelf life in the product as packaged for sale. 24 months
Shelf life after first opening the container. The emulsion should
be used directly due to the risk of microbiological contamination.
Any unused emulsion should be discarded.
Shelf life after addition or mixing according to directions.
When additions are made to infusion solution, the infusion should
be completed within 24 hours.
Special precautions for storage
Store below 25°C. Do not freeze.
After addition of other nutritional elements
Mixing in plastic bag (phthalate free film): Mixtures aseptically
prepared in a controlled and validated aseptic area should be used
within 7 days after preparation. The mixtures can be stored up to
6 days in a refrigerator (2-8°C) followed by an infusion period of
up to 24 hours.
Nature and contents of container
Type II glass and butyl rubber stopper.
- All packaging components are latex- and PVC-free.
The container consists of an inner
bag and an overpouch. An oxygen absorber and integrity indicator
are placed between the inner bag and the overpouch. The inner
bag is the primary container for Intralipid. The overpouch provides
protection during storage by contributing with barrier properties
towards water and oxygen to the Intralipid container system. The
oxygen absorber will absorb and bind oxygen remaining between
the inner bag and the overpouch. The integrity indicator will react
with free oxygen and change from clear to black in case of a
- The inner bag is made of a multilayer polymer film, Biofine
- The Biofine inner bag film consists of poly(propylene/
ethylene) copolymer and thermoplastic elastomers (SEBS and
SIS). The infusion and additive ports are made of polypropylene
and a thermoplastic elastomer (SEBS) equipped with synthetic
- The oxygen barrier overpouch consists of polyolefin and
polyethylene terephtalate or polyolefin, polyethylene
terephtalate and poly(ethyl vinyl) alcohol (EVOH).
- The oxygen absorber consists of iron powder in a polymer
- The integrity indicator (OxalertTM) consists of an oxygen sensitive
solution in a polymer sachet.
- All packaging components are latex- and PVC-free.
Instructions for use/handling
Do not use if the package is damaged.
Infusion bag: The integrity indicator (OxalertTM) should be
inspected before removing the overpouch. If the indicator is
black, oxygen has penetrated the overpouch and the product
should be discarded.
The overpouch, the oxygen absorber and the integrity indicator
should be discarded after opening of the overpouch.
Additions should be made aseptically. Single administration
of electrolyte solutions to INTRALIPID should not be made.
Only medicinal, nutritional or electrolyte solutions for which
compatibility has been documented may be added as directed.
Compatibility data are available from the manufacturer for a
number of mixtures. The left over contents of opened bottles /
bags should be discarded and not saved for later use.
DATE OF REVISION OF THE TEXT
Instruction for use - Fresenius Kabi infusion bag
2. Remove the overwrap by tearing at the notch
and pulling down along the container.
The Oxalert™ sachet A and the oxygen absorber
B should be disposed.
1. The integrity indicator (Oxalert™) A should be
inspected before removing the overwrap. If
the indicator is black the overwrap is damaged
and the product should be discarded.
3. If additives are to be used break off
the tamper-evident arrow flag from
the white additive port. If no additives
are to be used go to figure 5.
4. Insert the needle horizontally through
the centre of the septum of the additive
port and inject the additives (with known
compatibility). Use syringes with needles of
18 - 23 gauge and a length of max. 40 mm.
5. Use a non-vented infusion set or close the air vent on
a vented set. Follow the instructions for use for the
infusion set. Use a spike with diameter as specified in
ISO 8536-4, 5.6 +/- 0.1 mm..
6. Break off the tamper-evident arrow
flag from the blue infusion port.
7. Hold the base of the infusion port.
Insert the spike through the infusion
port, by rotating your wrist slighly until
the spike is inserted.
8. Hang the bag in the hanger cut and start infusion.