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INTRALIPID 20%

Active substance(s): SOYBEAN OIL PURIFIED

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Emulsion for infusion
Purified soybean oil

PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start
using this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• If you get any side effects, talk to your doctor or
pharmacist.
This includes any side effects not listed in this leaflet.
See section 4 .
In this leaflet:
1. What Intralipid 20% is and what it is used for
2. What you need to know before you use Intralipid 20%
3. How to use Intralipid 20%
4. Possible side effects
5. How to store Intralipid 20%
6. Contents of the pack and other information
1. What Intralipid 20% is and what it is used for
Intralipid 20% is used as a source of calories and fatty acids
when you cannot eat normally. Intralipid 20% is particularly
useful following trauma, infections or severe burns.
Intralipid 20% may be mixed with carbohydrates, amino
acids, salts, vitamins and trace elements which together
provide your complete nutritional needs.
2. What you need to know before you use Intralipid 20%
Do not use Intralipid 20% if you:
• are allergic (hypersensitive) to Intralipid 20% or any of
the ingredients of Intralipid 20% mentioned in section 6
(for symptoms of an allergic reaction, please refer to
section 4)
• have a disorder of fat metabolism such as in severe liver
damage or if you have suffered from shock
Warnings and precautions
Talk to your doctor or pharmacist before using Intralipid 20%
Inform your doctor if you suffer from:
• an allergy to products containing egg, soya or peanut oil.
Your doctor will carry out an allergy test to make sure
you can receive this medicine.
• reduced liver function



Intralipid 20% w/v
®

• a condition where your body has problems using fat
properly
• impaired kidneys
• any problems with your pancreas
• untreated diabetes mellitus
• thyroid problems- hypothyroidism
• sepsis (a condition in which your body is fighting a
severe infection)

The following information is intended for healthcare professionals only.
Instructions for use - Fresenius Kabi infusion bag
1.

2.

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.

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.

3.

4.

3. If additives are to be used break off the tamper-evident
arrow flag from the white additive port. If no additives
(of known compatibility) 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.

If Intralipid 20% is given to your newborn baby, tell your
doctor if they have been born prematurely or were of a
low birth weight as they may become jaundiced (yellowing
of skin or eyes).If your child has high blood pressure in
the lungs (pulmonary hypertension) inform your doctor or
nurse so that they can be monitored closely.
This medicine may interfere with certain laboratory tests.
It is important to tell any doctor doing tests that you are
using Intralipid 20%.
Your doctor may want to do regular blood tests to make
sure your body is using Intralipid 20% correctly.
Other medicines and Intralipid 20%
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Inform your doctor if you are taking
• any anticoagulants to help prevent blood clots, eg.
heparin or warfarin
• insulin for the treatment of diabetes mellitus
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine.
The doctor will decide if you should receive Intralipid 20%.
Driving and using machines
Intralipid 20% may cause tiredness and headache which
may affect your ability to drive or use machinery. Ask your
doctor when it would be safe to drive or operate machines.
3. How to use Intralipid 20%
You will receive your medicine by intravenous infusion (IV
drip). The amount and rate at which the infusion is given
depends on your requirements. Your doctor will decide on
the correct dose for you or your baby to receive. You will
be monitored during your treatment.
If you receive too much Intralipid 20%
It is very unlikely that you will receive more infusion than
you should as your doctor or nurse will monitor you
during the treatment. However, if you think you received
too much Intralipid 20% inform your doctor or nurse
immediately. In case of overdose there is a risk of taking

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5.

6.
Closed

in too much fat. This is called ’fat overload syndrome’. See
section 4 ’’Possible side effects’’ for more information.
If you have any further questions on the use of this
product, ask your doctor or nurse.
4. Possible side effects
Like all medicines, Intralipid 20% can cause side effects,
although not everybody gets them.
Intralipid 20% may cause severe allergic reactions.
If you get any of the following symptoms after
receiving this medicine you should contact your
doctor immediately:
• a rash appears on your body
• you have swollen face, tongue and throat
• you have difficulties breathing
• stomach pain

Non-vented

The following side effects have also been reported:

Vented

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.

8.



Extremely rarely (occurs in less than one in a million
infusions)
• headache
• blood and circulatory problems
• tiredness
• painful erections in men
• cholestasis- a condition in which bile is not flowing
properly from the liver to the intestines
• jaundice - skin and whites of eyes turn yellow
• abnormal liver test results- these will get back to normal
after the treatment with Intralipid 20% is finished
Prolonged treatment with Intralipid 20% in infants has
been reported to cause bleeding disorders.
Fat overload syndrome
This might happen when your body has problems using fat,
because of having too much Intralipid 20%. It may also
happen because of a sudden change in your condition (such
as kidney problems or infection). Possible signs are fever,
problems in various organs and coma. All these symptoms
will usually disappear when you stop having the infusion.
Common (occurs in one in a hundred patients): Rise in
body temperature, shivering, chills, feeling sick and being
sick. If this happens to you tell your doctor straight away,
as Intralipid 20% administration needs to be stopped.

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.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this
leaflet.
You can also report side effects directly
In the UK: via the Yellow Card Scheme at: www.mhra.gov.
uk/yellowcard.

In Ireland: HPRA Pharmacovigilance, Earlsfort Terrace,
IRL- Dublin 2.
Or by email to medsafety@hpre.ie
In Malta: via the ADR reporting website: www.medicinesauthority.
gov.mt/adrportal
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Intralipid 20%
Keep this medicine out of the sight and reach of
children.
Your doctor and hospital pharmacist are responsible for
the correct storage, use and disposal of Intralipid 20%
infusion.
Do not store above 25°C. Do not freeze.
Do not use this medicine after the expiry date which is
stated on the label. The expiry date refers to the last day
of that month.
Do not throw away medicines via wastewater. Ask your
pharmacist how to throw away medicines you no longer
use. These measures will help protect the environment.
6. Contents of the pack and other information
What Intralipid 20% contains
One litre (1000 ml) contains the following: purified soybean
oil 200 grams.
The other ingredients are purified egg phospholipids,
glycerol, sodium hydroxide and water for injections.
What Intralipid 20% looks like and contents of the pack
Intralipid 20% is a white fat emulsion (a mixture of oil and
water). Intralipid 20% is supplied in sealed glass bottles
which contains either 500ml of this emulsion, biofine
bags containing 100ml, 250ml or 500ml of emulsion and
excel bags containing 100ml and 500ml of this emulsion.
These bags are wrapped in an overpouch with an additional
package in between the bag and the overpouch which is
an oxygen absorber and integrity indicator.
Not all pack sizes may be marketed.
Marketing authorisation holder
Fresenius Kabi Limited
Cestrian Court, Eastgate Way
Manor Park, Runcorn, Cheshire
WA7 1NT, UK
Manufacturer
Fresenius Kabi AB, 751 74 Uppsala, Sweden
This leaflet was last revised in April 2016
V002
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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