Skip to Content

INTRALIPID 10%

Active substance(s): SOYBEAN OIL PURIFIED

View full screen / Print PDF » Download PDF ⇩
Transcript
336 199 (replace 334 393)
Printspecifikation
Format:
420 x 210 mm
Colour: Black
Fontsize:
8 pt
Perforering

8:e korr 2016-05-26
Niklas Baudin
+46 18 64 43 69

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 10% is and what it is used for
2. What you need to know before you use Intralipid 10%
3. How to use Intralipid 10%
4. Possible side effects
5. How to store Intralipid 10%
6. Contents of the pack and other information
1. What Intralipid 10% is and what it is used for
Intralipid 10% is used as a source of calories and fatty acids when
you cannot eat normally. Intralipid 10% is particularly useful
following trauma, infections or severe burns.
Intralipid 10% 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 10%
Do not use Intralipid 10% if you:
• are allergic (hypersensitive) to Intralipid 10% or any of the
ingredients of Intralipid 10% 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 10% 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
• a condition where your body has problems using fat properly
• impaired kidneys

If Intralipid 10% is given to your newborn baby, tell your doctor
if they have been born prematurely or were of a low birth
weight or has high blood pressure in the lungs (pulmonary
hypertension), so that they can be monitored closely.



Intralipid 10% w/v
®

• any problems with your pancreas
• untreated diabetes mellitus
• thyroid problems- hypothyroidism
• sepsis (a condition in which your body is fighting a severe
infection)
• metabolic disorders

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 (with known
compatability) 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.

This medicine may interfere with certain laboratory tests. It is
important to tell any doctor doing tests that you are using
Intralipid 10%.
Your doctor may want to do regular blood tests to make sure your
body is using Intralipid 10% correctly.
Other medicines and Intralipid 10%
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 10%.
Driving and using machines
Intralipid 10% does not affect your ability to drive or use machinery.
3. How to use Intralipid 10%
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 10%
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 10% inform your doctor or nurse immediately. In case
of overdose there is a risk of taking in too much fat. This is called
’fat overload syndrome’ (see below).

336 199



5.

6.
Closed

Fat overload syndrome
This might happen when your body has problems using fat,
because of having too much Intralipid 10%. It may also happen
because of a sudden change in your condition (such as kidney
problems or infection). Possible signs are fever, fat infiltration,
elevated fat levels, problems in various organs and coma. All
these symptoms will usually disappear when you stop having the
infusion.
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 10% can cause side effects, although
not everybody gets them.

Non-vented

Rise in body temperature, shivering, chills, feeling sick and being
sick. If this happens to you tell your doctor straight away, as
Intralipid 10% administration needs to be stopped.

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.


Intralipid 10% 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
• pale red itchy bumps causing a burning or stinging sensation
The following side effects have also been reported:

7.

8.

Extremely rarely (occurs in less than one in a million infusions)
• stomach pain
• 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 10% is finished
Prolonged treatment with Intralipid 10% in infants has been
reported to cause bleeding disorders.

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

By reporting side effects you can help provide more information
on the safety of this medicine.
5. How to store Intralipid 10%
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 10% 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 10% contains
One litre (1000 ml) contains the following: purified soybean oil
100 grams.
The other ingredients are purified egg phospholipids, glycerol,
sodium hydroxide and water for injections.
What Intralipid 10% looks like and contents of the pack
Intralipid 10% is a white fat emulsion (a mixture of oil and water).
Intralipid 10% is supplied in sealed glass bottles which contains
either 100 ml or 500 ml of this emulsion, excel bags or biofine
bags containing 100 ml or 500 ml 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 May 2016

V002
336 199

Expand view ⇕

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.

Hide