LIPIDEM 200 mg /Ml Эмульсия Для Внутривенного Введения

Содержание инструкции

1. Lipidem 200 mg/ml emulsion for infusion
   1. What is Lipidem 200 mg/ml and what is it used for
   2. What you need to know before you take Lipidem 200 mg/ml
   3. How to use Lipidem 200 mg/ml
   4. Possible side effects
   5. How to store Lipidem 200 mg/ml
   6. Package Contents and Other Information

Lipidem 200 mg/ml emulsion for infusion

Medium chain triglycerides / refined soybean oil / triglycerides with omega-3 fatty acids

Read this leaflet carefully before you start to use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Lipidem 200 mg/ml is and what it is used for.
• 2. What you need to know before you use Lipidem 200 mg/ml.
• 3. How to use Lipidem 200 mg/ml.
• 4. Possible side effects.
• 5. How to store Lipidem 200 mg/ml.
• 6. Contents of the pack and other information.

1. What is Lipidem 200 mg/ml and what is it used for

Lipidem 200 mg/ml is an oil-in-water emulsion. The oils contained in Lipidem 200 mg/ml provide
energy and contain essential fatty acids that the body needs to grow or heal.
Lipidem 200 mg/ml is used to provide fats to patients who need to be nourished via infusion therapy
because they are unable to feed normally or if normal nutrition is insufficient.
Lipidem is indicated in adults, preterm and term newborns, in early infancy, infants, children and
adolescents.

2. What you need to know before you take Lipidem 200 mg/ml

DO NOT use Lipidem 200 mg/ml
if one or more of the following conditions are present:

• if you are allergic to egg, fish, peanuts, soybean seed proteins or any of the other ingredients of this medicine (listed in section 6).
• High and abnormal levels of fats in the blood (severe hyperlipidemia characterized by hypertriglyceridemia)
• Conditions in which the blood does not coagulate properly (severe coagulopathy)
• Unstable bile flow (intrahepatic cholestasis)
• Severely impaired liver function (severe hepatic insufficiency)
• Severely impaired kidney function (severe renal insufficiency) without resorting to treatment with an artificial kidney (hemofiltration or dialysis)
• Blockage of blood vessels by thrombi or fat (acute thromboembolic episodes, fat embolism)
• Unusually high levels of acidic substances in the blood (acidosis)

Generally patients should not receive artificial nutrition via intravenous infusion
(parenteral nutrition)
if one or more of the following conditions are present:

• Potentially life-threatening circulatory problems, such as those that can occur in the event of collapse and shock.
• Heart attack (myocardial infarction) or stroke in the acute phase.
• Unstable metabolic conditions, for example due to diabetes mellitus, infections involving the whole body (severe sepsis) or coma of unknown origin.
• Insufficient oxygen supply to the tissues.
• Disorders in the composition of the body's salts.
• Lack of fluids or excess water in the body.
• Water in the lungs (acute pulmonary edema).
• Severe heart failure (decompensated heart failure).

Warnings and precautions
Talk to your doctor before taking Lipidem 200 mg/ml.

Monitoring

• During the infusion, the amount of lipids in your blood (serum triglycerides) must be monitored by the doctor. If your blood lipid levels reach a level that is too high, the doctor may reduce the infusion rate or stop the infusion.
• While you are being given this solution, your doctor must check your fluid and salt levels in the blood and the acid-base balance. Your liver, kidney and coagulation function must be monitored and a blood cell count must be performed.
• If you show signs of an allergic reaction (such as fever, chills, rash or breathing problems) when you are given this medicine, the infusion must be stopped immediately by the doctor.

Additional measures

• Before you are given this medicine, the doctor must ensure that any existing problems relating to the fluid and salt content of your body and the acid-base balance are corrected.
• In addition to Lipidem 200 mg/ml, you may be given a carbohydrate solution and an amino acid solution to avoid metabolic conditions in which your blood becomes acidic (metabolic acidosis).
• To complete your infusion nutrition, you may also be given carbohydrate solutions and amino acid solutions. The nursing staff may also take steps to ensure that the requirements relating to the level of fluids, electrolytes, vitamins and trace elements in your body are met.

Elderly patients
In some conditions, your ability to properly use fats may be impaired. The
doctor must take into account the fact that some of these conditions, for example cardiac or renal
function, are frequently linked to advanced age.

Patients with heart or kidney problems
If you suffer from heart or kidney problems, the doctor will be particularly cautious in giving you this
medicine.

Patients with impaired lipid metabolism
In some conditions, your ability to use fats correctly may be impaired and your
blood lipid levels may be too high. Therefore, it is important that the doctor knows:

• If you suffer from diabetes mellitus.
• If you suffer from inflammation of the pancreas (pancreatitis).
• If you suffer from impaired kidney or liver function (renal insufficiency, altered liver function).
• If you suffer from reduced activity of the thyroid gland (hypothyroidism).
• If you have a blood infection (sepsis).
• If you have a condition characterized by a combination of 3 or more of the following elements: increased abdominal fat, decreased amount of "good" cholesterol (HDL-C), increased blood fat levels, high blood pressure, increased blood sugar levels (metabolic syndrome). If your ability to use fats correctly is impaired, the doctor must carefully monitor your blood fat levels (serum triglycerides).

Children and adolescents
In newborns at risk of jaundice, the levels of fats (serum triglycerides) and bilirubin in the blood must be
monitored by the doctor. It may be necessary for the doctor to adjust the daily doses of fats.
During the infusion, this solution must be protected from light used in phototherapy to reduce the
formation of potentially harmful substances (hydroperoxide triglycerides).

Other medicines and Lipidem 200 mg/ml
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Lipidem 200 mg/ml can interact with other medicines. Tell your doctor if you are taking or are being
given medicines that prevent unwanted blood clotting, such as

• Heparin
• Cumarin-based products, for example warfarin. It may be necessary to check your blood clotting by taking regular blood tests.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor for advice before taking this medicine.

Pregnancy
If you are pregnant, you should only take this medicine if the doctor considers it absolutely
necessary for your recovery. There is no information on the use of Lipidem 200 mg/ml in pregnant
women.

Breastfeeding
Breastfeeding is not recommended for mothers receiving parenteral nutrition.

Driving and using machines
You will take this medicine in a controlled environment, for example a hospital or under any
type of medical supervision that normally excludes driving vehicles or using machinery.

Lipidem 200 mg/ml contains sodium
Lipidem 200 mg/ml contains 2.6 mmol/l of sodium. This must be taken into consideration in patients
on a low-sodium diet.

3. How to use Lipidem 200 mg/ml

Dosage
The doctor will decide how much of this medicine is needed and for how long you will need treatment with this medicine.
Daily doses will be adjusted based on your needs, your age and your body weight. Doses are normally calculated based on a “gram of fat per kg of body weight”. Care will be taken to ensure that the doses and infusion rate used are correct for you, so that your body's ability to utilize the infused fats is not overloaded.

How is Lipidem 200 mg/ml administered?
Lipidem 200 mg/ml must be administered via intravenous therapy as part of a nutrition program. For this reason, a tube (catheter) will be inserted into a vein through which the lipid emulsion can be administered separately or together with other fluids.

If you take more Lipidem 200 mg/ml than you should
If you have taken too much Lipidem 200 mg/ml you may experience unusually high levels of lipids in the blood (hyperlipidemia), your blood may become too acidic (metabolic acidosis) or you may suffer from the so-called “Fat Overload Syndrome”. For the symptoms of Fat Overload Syndrome see paragraph 4 “Possible side effects”.
If you have taken too much Lipidem 200 mg/ml, the infusion will be stopped immediately. The infusion will not be restarted until you have recovered. It may be necessary to make changes to the daily lipid doses. The doctor will decide whether further treatment is necessary.
If you have any doubts about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

The following side effects may be serious. If you experience any of the following side effects,
contact your doctor immediately and the administration of this medicine will be stopped:
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 (dyspnea).
• Bluish skin (cyanosis). Other side effects includeVery rare: may affect up to 1 in 10,000
• Fat overload syndrome (see “Fat overload syndrome” below).
• Increased tendency of your blood to clot (hypercoagulation).
• Unusually high levels of fats in the blood (hyperlipidemia).
• Unusually high levels of sugars in the blood (hyperglycemia).
• High levels of acidic substances in the blood (metabolic acidosis).
• Increase or decrease in blood pressure.
• Drowsiness.
• Nausea, vomiting, loss of appetite.
• Headache.
• Hot flashes.
• Skin redness (erythema).
• Fever.
• Sweating.
• Feeling cold, chills.

Rare: may affect up to 1 in 1,000 people

• Back pain, bone pain and in the chest and lower back area.

Not known: frequency cannot be estimated from available data

• Impaired bile flow (cholestasis).
• Decreased white blood cell count (leukopenia).
• Decreased platelet count (thrombocytopenia).

If you experience any of these side effects, the infusion will be stopped.

Fat overload syndrome:
You may suffer from a “Fat overload syndrome” if you have received too much Lipidem 200 mg/ml or
when your body has difficulty using fats. Your body's ability to use fats may
be affected by a sudden change in your condition (due to kidney problems or
an infection). The symptoms are usually reversible if the infusion is stopped. The Syndrome from
fat overload is characterized by the following symptoms:

• High levels of lipids in the blood (hyperlipidemia).
• Fever.
• Fat deposits in the liver or other organs (lipid infiltration).
• Enlargement of the liver (hepatomegaly) which may sometimes be accompanied by jaundice.
• Enlargement of the spleen (splenomegaly).
• Decreased red blood cell count (anemia).
• Decreased white blood cell count (leukopenia).
• Decreased platelet count (thrombocytopenia).
• Blood clotting disorders.
• Destruction of red blood cells (hemolysis).
• Increased immature red blood cells (reticulocytosis).
• Alteration of liver function tests.
• Loss of consciousness (coma).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. Side effects can also be reported directly through
the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. Reporting
of side effects helps to provide more information on the safety of this medicine.

5. How to store Lipidem 200 mg/ml

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 bottle label and on the
outer packaging. The expiry date refers to the last day of that month.
After first opening Lipidem 200 mg/ml must be used immediately.
Do not store at a temperature above 25°C.
Keep the bottle in the original packaging to protect the medicine from light.
Do not freeze. The product that has been frozen must be discarded.
Do not use this medicine if you notice:

• Large oil droplets in the emulsion or two separate layers of liquid.
• Discoloration.
• Damage to the container or closure.

6. Package Contents and Other Information

What Lipidem 200 mg/ml contains

• The active ingredients in 1000 ml of Lipidem 200 mg/ml are:
• Medium chain triglycerides 100.0 g
• Refined soybean oil 80.0 g
• Triglycerides with omega-3 fatty acids 20.0 g

This provides the following essential fatty acid content per liter:

• Linoleic acid (omega-6) from 38.4 to 46.4 g
• Alpha-linolenic acid (omega-3) from 4.0 to 8.8 g
• Eicosapentaenoic acid and

docosahexaenoic acid (omega-3) from 8.6 to 17.2 g
200 mg/ml (20%) corresponds to the total triglyceride content.
Energy [kJ/l (kcal/l)] 7990 (1910)
Osmolality [mOsm/kg], approximately 410
Acidity or alkalinity (titration at pH 7.4) [mmol/l NaOH or HCl] <0.5
pH 6.5-8.5

• The other components are glycerol, egg lecithin, α-tocopherol, ascorbyl palmitate, sodium oleate, sodium hydroxide (for pH adjustment) and water for injections.

Description of the appearance of Lipidem 200 mg/ml and package contents
Lipidem 200 mg/ml is an oil-in-water emulsion for infusion, sterile, milky white in color (for
administration via infusion therapy).
It is supplied in glass bottles with rubber stoppers, packs:
10x100 ml, 1x250 ml, 10x250 ml, 1x500 ml, 10x500 ml, 1x1000 ml, 6x1000 ml.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer and final controller

• 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 European Economic Area with the following
denominations:
Austria: Lipidem Emulsion zur Infusion
Belgium: Lipoplus 200 mg/ml
Czech Republic: Lipoplus 20%
Germany: Lipidem Emulsion zur Infusion
Denmark: Lipidem
Estonia Lipidem
Spain: Lipoplus 20%
Finland: Lipoplus 200 mg/ml
France: Lipidem 200 mg/ml
Hungary Lipoplus
United Kingdom: Lipidem 200 mg/ml Emulsion for Infusion
Greece: Lipolus 20%
Italy: Lipidem 200 mg/ml
Luxembourg: Lipidem
Netherlands: Lipoplus 20%
Norway: Lipidem
Poland Lipidem
Portugal: Lipoplus
Sweden: Lipoplus
Slovakia: Lipoplus 20%
Slovenia Lipidem 200 mg/ml emulzija za infundiranje
The following information is intended exclusively for healthcare professionals:

Route of administration and special precautions for disposal and handling
Intravenous use.
Lipid emulsions are suitable for peripheral vein administration and can also be
administered separately through peripheral veins as part of total parenteral nutrition.
The Y-connector or transfer set should be positioned as close as possible to the patient if
lipid emulsions are administered together with carbohydrate and amino acid solutions.
Single-use product. The container and any unused residue must be disposed of after use. Do not reconnect
partially used containers.
Shake gently before use.
Use only containers that are intact and in which the emulsion is homogeneous and milky white. Check
visually for any phase separation before administration
(oil droplets, oil layer).
The emulsion must always be brought to room temperature naturally before infusion, i.e.
the product must not be placed in a heating device (such as an oven or
microwave).
If filters are used, they must be lipid-permeable.
Before infusing a lipid emulsion together with other solutions via Y-connectors or transfer sets, the compatibility of these liquids must be checked, especially when
administered with solutions to which drugs have been added. Particular care must be
taken when infusing the product with other solutions containing bivalent cations (such as calcium and
magnesium).

Duration of treatment
Since clinical experience with the use of Lipidem for long periods is limited, the medicine
should generally not be administered for more than one week. If it is considered necessary to prolong parenteral nutrition with lipid emulsions, Lipidem can be administered for longer periods, provided
adequate monitoring is carried out.

Infusion rate
The infusion must be administered at the lowest possible infusion rate. During the first 15 minutes
the infusion rate must be only 50% of the maximum infusion rate used.

Maximum infusion rate for adults
Up to 0.15 g of lipids per kg of body weight per hour.

Maximum infusion rate for premature infants, term infants, young children and infants
Up to 0.15 g of lipids per kg of body weight per hour.

Maximum infusion rate for children and adolescents
Up to 0.15 g of lipids per kg of body weight per hour.

Interference with laboratory tests
Lipids can 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, which can take 4 to 6 hours.

Incompatibilities
In the absence of incompatibility studies, this medicine should not be mixed with other medicines.
taken when infused with solutions containing bivalent cations (such as calcium and magnesium).

Shelf life after mixing with compatible additives
From a microbiological point of view, the product must be used immediately after the addition of
additives. If not used immediately after the addition of additives, the shelf life
after opening and the conditions of use are the responsibility of the user.
For complete information on this product, see the Summary of Product Characteristics of Lipidem 200
mg/ml.