PACKAGE LEAFLET: INFORMATION FOR THE USER
Lipoplus 200 mg/ml emulsion for infusion
Medium-chain triglycerides, soya-bean oil, omega-3-acid triglycerides
Read all of this leaflet carefully before you start using this medicine.
● 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. Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
● If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Lipoplus 200 mg/ml is and what it is used for
2. Before you use Lipoplus 200 mg/ml
3. How to use Lipoplus 200 mg/ml
4. Possible side effects
5. How to store Lipoplus 200 mg/ml
6. Further information
1.
WHAT LIPOPLUS 200 MG/ML IS AND WHAT IT IS USED FOR
Lipoplus 200 mg/ml is an emulsion of oils in water. The oils contained in Lipoplus 200 mg/ml are
foodstuffs. They provide energy and contain an essential nutrient, the essential fatty acids
omega-6 and omega-3.
Lipoplus 200 mg/ml is used to provide fat to adult patients needing to be fed by an intravenous drip,
because they are unable to eat food normally or the normal intake is not enough.
2.
BEFORE YOU USE LIPOPLUS 200 MG/ML
Do not use Lipoplus 200 mg/ml
if one or more of the following conditions are present:
● allergy to egg, fish, or soya-bean protein or to any of the ingredients of the emulsion, see section
6. “Further information”.
● abnormally high blood fat level (severe hyperlipidaemia)
● conditions where the blood does not clot properly (severe blood coagulation disorders)
● impaired bile flow (intrahepatic cholestasis)
● severe liver failure
● severe kidney failure without access to treatment with an artificial kidney (haemofiltration or
dialysis)
● acute phase of heart infarction (heart attack) or stroke
● acute blocking of blood vessels by blood clots or fat drops ( thromboembolic disease, lipid
embolism)
Patients should generally not receive intravenous drip (infusion therapy) if one or more of the
following conditions are present:
● severely impaired blood circulation, accompanied by massive impairment of heart function,
breathing, kidney and liver function, i.e. states of collapse or shock
● unstable metabolism, for example because of severe injury, diabetes mellitus, blood poisoning
(sepsis, an infection involving the whole body) or abnormally high level of acidic substances in
the blood (acidosis)
● water in the lungs (acute pulmonary oedema)
● excess water in the body (hyper hydration)
●
●
●
heart failure ( decompensated cardiac insufficiency)
too low water and salt level in the body (hypotonic dehydration)
too low potassium level in the blood ( hypokalaemia).
Special care will be taken with Lipoplus 200 mg/ml
Before this product is given to you, your doctor will check whether or not you have one or more of the
following conditions, in which the body may not be able to use fat correctly:
● diabetes mellitus
● inflammation of the pancreas (pancreatitis)
● impaired liver or kidney function
● lung disease
● reduced activity of the thyroid gland (hypothyroidism)
● blood poisoning (sepsis)
If you have any of these conditions, Lipoplus 200 mg/ml will only be administered if clearly needed
and special care will be taken to make sure this product will not be harmful to you.
Blood sampling
If you have a disorder of blood clotting or you are lacking vitamin K, the clotting of your blood will be
checked by taking blood samples.
To make sure that the fat emulsion is taken up by the body tissues from the blood circulation and is
used properly, blood samples will be taken and examined in a laboratory. The amount and rate of
infusion of the fat emulsion will be adjusted accordingly.
Blood samples will also be taken frequently to check and make sure that there are no changes in the
composition of your blood or in your liver function while you are receiving this product.
Combination with other solutions for intravenous feeding
Lipoplus 200 mg/ml infusions will not be given alone but always together with sufficient amounts of
amino acids and carbohydrate (normally glucose) infusions. This helps to avoid an accumulation of
some acidic substances (ketones) in your blood, which might make your blood acidic (acidosis).
Allergic reactions
If there is any sign of allergic reaction, e. g. fever, shivering, rash or dyspnoea (shortness of breath),
the infusion should be discontinued.
Taking or using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Lipoplus 200 mg/ml may interact with some other medicines. Please tell your doctor if you are taking
medicines that prevent undesirable blood clotting (anticoagulants). It may be necessary to check the
clotting of your blood by taking regular blood samples.
Pregnancy or breast-feeding
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 Lipoplus 200mg/ml in pregnant women.
Consideration should be given to stopping breast-feeding while under treatment with Lipoplus
200 mg/ml since there is no data on the use of this medicine in nursing mothers. Ask your doctor for
advice if you are breast-feeding.
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.
Important information about some of the ingredients of Lipoplus 200 mg/ml
Lipoplus 200 mg/ml contains 2.6 mmol/l sodium. This should be taken into consideration by patients
on a controlled sodium diet.
3.
HOW TO USE LIPOPLUS 200 MG/ML
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 and 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.
Adults
A normal dose is 5 – 10 ml of Lipoplus 200 mg/ml per kg body weight per day and the infusion will
be given at the lowest possible rate.
Children and adolescents
The safe and effective use of Lipoplus 200 mg/ml in children and adolescents has not been
established.
How long may Lipoplus 200 mg/ml be given?
Lipoplus 200mg/ml will normally be given over a period of 1 week.
Lipoplus 200 mg/ml may be given for a longer time if thought necessary by your doctor. Under these
circumstances, you will be carefully monitored.
How is Lipoplus 200 mg/ml given?
Lipoplus 200 mg/ml 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 Lipoplus 200 mg/ml than you should
If you have received too much Lipoplus 200 mg/ml you may suffer from a so-called ‘fat overload
syndrome’. This fat overload syndrome may also be associated with some concurrently existing
disorders like infections or kidney disease.
Symptoms of the fat overload syndrome may include:
● high levels of fat in the blood
● fever
● deposition of fat in the liver or other organs
● swelling of the liver, which may sometimes be accompanied by jaundice
● swelling of the spleen
● low levels of red blood cells, white blood cells and platelets
● disorder of blood clotting
● destruction of red blood cells and other blood abnormalities
●
●
abnormal liver function tests
loss of consciousness.
Marked overdose of fat emulsions may also lead to high level of acidic substances in the blood
(acidosis).
If this happens, the infusion of Lipoplus 200 mg/ml will be stopped immediately. Your doctor will
decide on any additional treatment to be given. The infusion will not be started again until you have
recovered. It may be necessary to make changes to the daily fat doses.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, Lipoplus 200 mg/ml can cause side effects, although not everybody gets them.
However, if the dosage instructions and the other instructions for use are observed, most of the side
effects will occur only very rarely.
If you experience the following, contact your doctor or hospital immediately.
Very rare (affecting less than 1 treated patient in 10,000):
● allergic reactions
● increased tendency of your blood to clot (hypercoagulation)
● breathing problems, cyanosis (bluish discoloration of the skin)
● fat overload syndrome.
As soon as a fat overload syndrome appears the fat infusion must be stopped. (See section 3, “If you
receive more Lipoplus 200 mg/ml than you should”.)
Other side effects include
Very rare (affecting less than 1 treated patient in 10,000):
● drowsiness
● drop or raise of blood pressure
● high blood fat and blood sugar levels, acidosis (These may occur more frequently when high lipid
doses are applied.)
● feeling sick, vomiting
● headache
● flushing
● fever
● sweating
● chills
● chest and back pain
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 national reporting system
listed in Appendix V. By reporting side effects you can help provide more information on the safety of
this medicine.
5.
HOW TO STORE LIPOPLUS 200 MG/ML
Keep out of the reach and sight of children.
Do not use Lipoplus 200 mg/ml 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 Lipoplus 200 mg/ml 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 will be discarded.
Do not use Lipoplus 200 mg/ml if you notice:
● large oil drops in the emulsion or two separate layers of fluid
● discoloration
● damage of the container or the closure.
6.
FURTHER INFORMATION
What Lipoplus 200 mg/ml contains
- The active substances in 1000 ml of Lipoplus 200 mg/ml are:
Medium-chain triglycerides
Soya-bean oil, refined
Omega-3-acid triglycerides
100.0 g
80.0 g
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.
- The other ingredients are glycerol, egg lecithin, all rac-α-tocopherol, ascorbyl palmitate, sodium
oleate, sodium hydroxide for pH adjustment and water for injections.
- The amount of energy supplied per litre of Lipoplus 200 mg/ml is 7900 kJ (1910 kcal).
What Lipoplus 200 mg/ml looks like and contents of the pack
Lipoplus 200 mg/ml is a milky white, sterile emulsion for infusion (for administration by a venous
drip)
It is supplied in
● glass bottles, pack sizes:
10 × 100 ml, 1 × 250 ml, 10 × 250 ml, 1 × 500 ml, 10 × 500 ml, 1 × 1000 ml, 6 × 1000 ml
● plastic bags, pack sizes:
1 × 250 ml, 10 × 250 ml, 1 × 500 ml, 10 × 500 m, 1 × 1000 ml, 10 × 1000 ml
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
[To be completed nationally]
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:
Ireland:
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
Lipidem 200 mg/ ml
Lipidem
Lipoplus 20%
Lipidem
Lipidem
Lipoplus
Lipoplus
Lipoplus 20%
Lipidem 200 mg/ml emulzija za infundiranje
This leaflet was last approved in 2014-12-19
--------------------------------------------------------------------------------------------------------------------------THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL OR HEALTHCARE
PROFESSIONALS ONLY:
Instruction for handling
Lipoplus 200 mg/ml is supplied in containers for single use.
Products that have been frozen and unused residues must be discarded.
Only use if the emulsion is homogeneous from intact containers. Inspect the emulsion visually for
phase separation prior to administration.
The emulsion should always be brought to room temperature prior to infusion.
If filters are used, these must allow the lipids (fat droplets) to pass through.
Before infusing a lipid emulsion together with other solutions via a Y connector or bypass set
(equipment that may be used to give this product together with other solutions), the compatibility of
these fluids should be checked, especially when given with carrier solutions containing other drugs.
Particular caution should be taken when infusing this product with other solutions containing certain
electrolytes (such as calcium).