LIPIDEM 200MG/ML EMULSION FOR INFUSION

PACKAGE LEAFLET: INFORMATION FOR THE USER

418/12260832/0316

B. Braun Melsungen AG, 34209 Melsungen, Germany

Lipidem 200 mg/ml

emulsion for infusion
Medium-chain triglycerides / soya-bean oil, refined / omega-3-acid triglycerides
Read all of this leaflet carefully before you are given 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.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Lipidem is and what is it used for
Lipidem is an emulsion of oils in water. The oils contained in Lipidem provide
energy and contain essential fatty acids that are needed for your body to
grow or recover.
Lipidem is used to provide fat to patients needing to be fed by an intravenous
drip, because they are unable to eat food normally or the normal intake is
not enough.
Lipidem is indicated in adults, preterm and term neonates, infants and
toddlers, children and adolescents.

2. What you need to know before you are given Lipidem
Lipidem must NOT be used
if one or more of the following conditions are present:
• if you are allergic to egg, fish, peanut, or soya-bean protein or any of
the other ingredients of this medicine (listed in section 6).
• abnormally high blood fat level (severe hyperlipidaemia characterised
by hypertriglyceridaemia)
• conditions where the blood does not clot properly (severe coagulopathy)
• impaired bile flow (intrahepatic cholestasis)
• severe liver failure (severe hepatic insufficiency)
• severe kidney failure (severe renal insufficiency) without access to
treatment with an artificial kidney (haemofiltration or dialysis)
• blocking of blood vessels by blood clots or fat (acute thromboembolic
events, fat embolism)
• abnormally high level of acidic substances in the blood (acidosis)
Patients must generally not receive artificial nutrition via intravenous
drip (parenteral nutrition)
if one or more of the following conditions are present:
• life-threatening blood circulation problems such as those that can
occur if you are in a state of collapse or shock
• acute phase of heart attack (cardiac infarction) or stroke
• unstable metabolism, for example because of diabetes mellitus,
infections involving the whole body (severe sepsis), or coma of unknown
origin
• insufficient supply of oxygen to tissues
• disturbances of your body salt composition
• fluid deficit or excess water in the body
• water in the lungs (acute pulmonary oedema)
• severe heart failure (decompensated cardiac insufficiency)

Warnings and precautions
Talk to your doctor before you are given Lipidem.
Monitoring
• During infusion, the amount of fat (serum triglycerides) in your blood
should be monitored by your doctor. If your blood fat values rises too
high, your doctor may reduce the infusion speed or stop the infusion.
• While you receive this solution, your doctor should check your levels
of fluids, blood salts and the acid-base balance. Your liver and kidney
function and your blood clotting function should be monitored and
blood cell counts should be performed.
• If you show signs of an allergic reaction – such as fever, shivering, rash,
or breathing problems – when you receive this medicine, the infusion
should be stopped immediately by your doctor.
Additional measures
• Before you receive this medicine any existing disorders of your body’s
fluid and salt content as well as disturbances of your acid-base balance
will be corrected by your doctor.
• In addition to Lipidem you may receive a carbohydrate solution and an
amino acid solution to prevent metabolic conditions where your blood
becomes acidic (metabolic acidosis).
• To make your intravenous feeding complete, you may also receive
carbohydrate solutions and amino acid solutions. The nursing staff may
also take measures to ensure that your body’s fluid, electrolyte, vitamin
and trace element requirements are met.
Elderly patients
In some conditions your ability to use fat correctly may be impaired. Your
doctor will keep in mind that some of these conditions are frequently
associated with advanced age, e.g. impaired heart or kidney function.
Patients with heart or kidney problems
If you have heart or kidney problems, your doctor will be especially careful
when giving you this medicine.

Patients with impaired lipid metabolism
In some conditions your ability to use fat correctly may be impaired and
your blood fat values may be too high. Therefore, it is important that your
doctor knows:
• if you have diabetes mellitus
• if you have an inflammation of the pancreas (pancreatitis)
• if you have impaired liver or kidney function (renal insufficiency,
impaired hepatic function)
• if you have a reduced activity of the thyroid gland (hypothyroidism)
• if you have blood poisoning (sepsis)
• if you have a condition where you may have a combination of 3 or more
of the following: an increase in fat around your abdomen, a decrease
in “good cholesterol” (HDL-C), an increase in your blood fat, high blood
pressure and an increase in your blood sugar (metabolic syndrome)
If your ability to use fat correctly is impaired, your doctor should monitor
your blood fat (serum triglyceride) levels very closely.
Children and adolescents
In infants at risk of jaundice the blood fat (serum triglyceride) and bilirubin
levels should be monitored by your doctor. It may become necessary for
your doctor to adjust the daily fat doses.
During infusion this solution should be protected from the light of a
phototherapy to decrease the formation of potentially harmful substances
(triglyceride hydroperoxides).
GB___418

Other medicines and Lipidem
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
Lipidem may interact with some other medicines. Tell your doctor if you
are taking or receiving certain medicines that prevent undesirable blood
clotting, namely
• heparin
• coumarin products, for example warfarin.
It may be necessary to check the clotting of your blood by taking regular
blood samples.

418/12260832/0316
GIF (IL)
Standort Melsungen
Font size: 9 pt.
G 120698

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 for advice before you are given
this medicine.
Pregnancy
If you are pregnant you will receive this medicine only if the doctor
considers it absolutely necessary for your recovery. There is no data about
the use of Lipidem in pregnant women.
Breast-feeding
Breast-feeding is not recommended for mothers on parenteral nutrition.

Driving and using machines
You will receive this medicine in a controlled setting, i.e. a hospital or
under any other kind of medical supervision, which normally excludes
driving or using machines.
Lipidem contains sodium
Lipidem contains 2.6 mmol/l sodium. This should be taken into
consideration by patients on a controlled sodium diet.

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What is in this leaflet
1. What Lipidem is and27.08.2003
what it is used for
NP34082.210x440mm.340.0803
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2. What you need to know before you are given Lipidem
3. How to use Lipidem
4. Possible side effects
5. How to store Lipidem
6. Content of the pack and other information

3. How to use Lipidem
Dosage
Your doctor will decide how much of this medicine you need and for how
long you will require treatment with this medicine.
The daily doses will be adjusted to your needs, your age and your body
weight. The doses are normally calculated on a “gram of fat per kg body
weight” basis. Care will be taken that the doses and infusion rates used
are correct for you, so your body’s capacity to use the infused fat will not
be exceeded.

How is Lipidem given?
Lipidem will be given by an intravenous drip as part of a feeding
programme. For this purpose a tube (catheter) will be inserted into a vein,
through which the fat emulsion can either be given separately or together
with other fluids.

If you received more Lipidem than you should
If you have received too much Lipidem you may get abnormally high blood
fat levels (hyperlipidaemia), your blood may become too acidic (metabolic
acidosis) or you may suffer from a so-called “fat overload syndrome”. For
symptoms of the fat overload syndrome please see section 4 “Possible
side effects”.
If you have received too much Lipidem the infusion will be stopped
immediately. The infusion will not be started again until you have
recovered. It may be necessary for your doctor to adjust the daily fat
doses. Your doctor will decide on any additional treatment.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

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4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
The following side effects may be serious. If any of the following side
effects occur, contact your doctor immediately, they will stop giving
you this medicine:
Very rare: may affect up to 1 in 10,000 people
• allergic reactions, for example skin reactions, shortness of breath,
swelling of the lips, mouth and throat, difficulty breathing
• breathing problems (dyspnoea)
• bluish skin (cyanosis)
Other side effects include
Very rare: may affect up to 1 in 10,000 people
• fat overload syndrome (see “Fat overload syndrome” below)
• increased tendency of your blood to clot (hypercoagulation)
NP34082.210x440mm.340.0803
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• abnormally high blood
fat levels (hyperlipidaemia)
• abnormally high blood sugar levels (hyperglycaemia)
• high levels of acidic substances in your blood (metabolic acidosis)
• decrease or increase in blood pressure
• drowsiness
• feeling sick, vomiting, loss of appetite
• headache
• flushing
• reddening of the skin (erythema)
• fever
• sweating
• feeling cold, chills
Rare: may affect up to 1 in 1,000 people
• pain in the back, bones, chest and lumbar region
Not known: frequency cannot be estimated from the available data
• impaired bile flow (cholestasis)
• reduction of white blood cell count (leucopenia)
• reduction of blood platelet count (thrombocytopenia)
If you get any of these side effects, the infusion will be stopped.

Fat overload syndrome:
You might suffer from a “fat overload syndrome” if you have received
too much Lipidem or when your body has problems using fat. Your
body’s ability to use fat might be influenced by a sudden change in your
condition (due to renal problems or an infection). The symptoms are
usually reversible if the infusion is stopped. A fat overload syndrome is
characterised by the following symptoms:
• high blood fat levels (hyperlipidaemia)
• fever
• deposition of fat in the liver or other organs (fat infiltration)
• enlargement of the liver (hepatomegaly), which may sometimes be
accompanied by jaundice (icterus)
• enlargement of the spleen (splenomegaly)
• reduction of red blood cell count (anaemia)
• reduction of white blood cell count (leucopenia)
• reduction of blood platelet count (thrombocytopenia)
• disorder of blood clotting (coagulation disorder)
• rupture of blood cells (haemolysis)
• increase in immature red blood cells (reticulocytosis)
• abnormal liver function tests
• loss of consciousness (coma)

What Lipidem looks like and contents of the pack
Lipidem is a milky-white, sterile oil-in-water emulsion for infusion (for
administration by a venous drip).
It is supplied in glass bottles with rubber stoppers, pack sizes:
10 × 100 ml, 1 × 250 ml, 10 × 250 ml, 1 × 500 ml, 10 × 500 ml,
1 × 1000 ml, 6 × 1000 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen, Germany
Postal address
34209 Melsungen, Germany

This medicinal product is authorised in the Member States of
the EEA under the following names:
Austria:
Belgium:
Czech Republic:
Germany:
Denmark:
Estonia:
Spain:
Finland:
France:
Hungary:
United Kingdom:
Greece:
Italy:
Luxembourg:
Netherlands:
Norway:
Poland:
Portugal:
Sweden:
Slovakia:
Slovenia:

Lipidem Emulsion zur Infusion
Lipoplus 200 mg/ml
Lipoplus 20%
Lipidem Emulsion zur Infusion
Lipidem
Lipidem
Lipoplus 20%
Lipoplus 200 mg/ml
Lipidem 200 mg/ml
Lipoplus
Lipidem 200 mg/ml Emulsion for Infusion
Lipoplus 20%
Lipidem 200 mg/ ml
Lipidem
Lipoplus 20%
Lipidem
Lipidem
Lipoplus
Lipoplus
Lipoplus 20%
Lipidem 200 mg/ml emulzija za infundiranje

This leaflet was last revised in 03/2016.

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 via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Lipidem

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Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label
and the outer carton. The expiry date refers to the last day of that month.
After first opening Lipidem should be used immediately.
Do not store above 25 °C.
Keep the container in the outer carton in order to protect from light.
Do not freeze. Products that have been frozen must be discarded.
Do not use this medicine if you notice:
• large oil drops in the emulsion or two separate layers of fluid
• discoloration
• damage of the container or the closure.

6. Content of the pack and other information
What Lipidem contains
- The active substances in 1000 ml of Lipidem are:
Medium-chain triglycerides
100.0 g
Soya-bean oil, refined
80.0 g
Omega-3-acid triglycerides
20.0 g
This gives the following content of essential fatty acids per litre:
Linoleic acid (omega-6)
38.4 - 46.4 g
Alpha-linolenic acid (omega-3)
4.0 - 8.8 g
Eicosapentaenoic acid and
docosahexaenoic acid (omega-3) 8.6 - 17.2 g
200 mg/ml (20%) correspond to total content of triglycerides.
Energy [kJ/l (kcal/l)]
7990 (1910)
Osmolality [mOsm/kg], approximately
410
Acidity or alkalinity (titration to pH 7.4) [mmol/l NaOH or HCl]
< 0.5
pH
6.5 - 8.5
- The other ingredients are glycerol, egg lecithin, all-rac-α-Tocopherol,
ascorbyl palmitate, sodium oleate, sodium hydroxide (for pH adjustment)
and water for injections.

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The following information is intended for healthcare professionals only:
Method of administration and special precautions fordisposal and other handling
Intravenous use.
Lipid emulsions are suitable for peripheral venous administration and can also be administered separately via peripheral veins as part of total parenteral
nutrition.
The Y- or the bypass connector should be placed as close to the patient as possible if lipid emulsions are co-administered with amino acid and
carbohydrate solutions.
For single use only. Container and unused residues must be discarded after use. Do not reconnect partially used containers. Shake gently prior to use.
Only use containers that are undamaged and in which the emulsion is homogeneous and milky-white. Inspect the emulsion visually for phase separation
prior to administration (oil drops, oil layer).
The emulsion has to be brought to room temperature unaided prior to infusion, i.e., the product should not be put in a heating device (such as oven or
microwave).
If filters are used, these must be permeable to lipids.
Before infusing a lipid emulsion together with other solutions via a Y connector or bypass set, the compatibility of these fluids should be checked,
especially when co-administering carrier solutions to which drugs have been added. Particular caution should be taken when co-infusing solutions that
contain divalent cations (such as calcium or magnesium).
Duration of treatment
As clinical experience with long-term use of Lipidem is limited, it should normally not be administered for longer than one week. If parenteral nutrition
with lipid emulsions is further indicated, Lipidem can be administered over longer periods provided appropriate monitoring is employed.
Infusion rate
The infusion should be administered at the lowest possible infusion rate. During the first 15 minutes the infusion rate should only be 50% of the
maximum infusion rate to be used.
Maximum infusion rate for adults
Up to 0.15 g/kg b.w./h lipids.
Maximum infusion rate for preterm newborn infants, term newborn infants, infants and toddlers
Up to 0.15 g/kg b.w./h lipids.
Maximum infusion rate for children and adolescents
Up to 0.15 g/kg b.w./h lipids.
Interference with laboratory tests
Lipids may interfere with certain laboratory tests (such as bilirubin, lactate dehydrogenase, oxygen saturation) when the blood sample is taken before
the lipids have been eliminated from the bloodstream, this may take 4 to 6 hours.
Incompatibilities
Lipidem may only be mixed with other medicinal products for which compatibility has been documented (see section 4.4 of the Summary of Product
Characteristics).
Compatibility data for different additives (e.g. carbohydrates, electrolytes, trace elements, vitamins) and the corresponding shelf life of such admixtures
can be provided on demand by the manufacturer.

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Shelf life after admixture of compatible additives
From a microbiological point of view, the product should be used immediately after admixture of additives. If not used immediately after admixture of
additives, in-use storage times and conditions prior to use are the responsibility of the user.
For full information on this product please refer to the Summary of Product Characteristics of Lipidem.

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