Lipoflex special

Leaflet accompanying the packaging: information for the user

Lipoflex special, infusion emulsion

Please read carefully the contents of the leaflet before using the medicine, as it contains

important information for the patient.

• Please keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Lipoflex special and what is it used for
• 2. Important information before using Lipoflex special
• 3. How to use Lipoflex special
• 4. Possible side effects
• 5. How to store Lipoflex special
• 6. Contents of the packaging and other information

1. What is Lipoflex special and what is it used for

Lipoflex special contains fluids and substances, including amino acids, electrolytes, and fatty acids, which are necessary for growth or regeneration of the body. It also contains calories in the form of carbohydrates and fats.
This medicine is given to patients who are unable to eat normally. There are many situations in which this may occur, for example, after surgery, injury, or burns, or when the patient has difficulty absorbing food from the stomach or intestines.
This infusion emulsion can be administered to adults, adolescents, and children over 2 years of age.

2. Important information before using Lipoflex special

When not to use Lipoflex special

• If the patient is allergic to the active substances, egg protein, peanuts, or soy, or any of the other ingredients of this medicine (listed in section 6).
• The medicine must not be given to newborns, infants, and children under 2 years of age.

This medicine must not be used in the following cases:

• life-threatening circulatory disorders that occur during shock or collapse,
• heart attack or stroke,
• severe blood clotting disorders, risk of bleeding (severe coagulopathy, exacerbation of bleeding disorders),
• blockage of blood vessels by blood clots or fat (embolism),
• severe liver failure,
• impairment of bile flow (intrahepatic cholestasis),
• severe kidney failure without replacement therapy,
• disorders of mineral salt composition in the body,
• fluid deficiency or excess in the body,
• fluid in the lungs (pulmonary edema),
• severe heart failure,
• certain metabolic disorders, such as:
• excessive fat in the blood,
• inborn errors of amino acid metabolism,
• abnormally high blood sugar levels, which require the administration of more than 6 units of insulin per hour,
• metabolic disorders occurring after surgical procedures or injuries,
• coma of unknown origin,
• insufficient oxygen supply to tissues,
• abnormally high levels of acids in the blood.

Warnings and precautions

Before starting treatment with Lipoflex special, the patient should discuss it with their doctor, pharmacist, or nurse.
The patient should inform their doctor if they have:

• heart, liver, or kidney problems,
• certain metabolic disorders, such as diabetes, abnormal fat levels in the blood, or disorders of water and electrolyte balance in the body or acid-base balance.

During treatment with Lipoflex special, the patient will be closely monitored to detect early signs of an allergic reaction (such as fever, chills, rash, or shortness of breath).
Additional monitoring and laboratory tests, including various blood tests, will be performed to ensure that the patient's body is handling the nutrients properly.
Nursing staff may take action to ensure that the patient's body is receiving sufficient fluids and electrolytes. The patient may receive other nutritional components in addition to this medicine to fully meet the body's needs.

Children

This medicine must not be given to newborns, infants, and children under 2 years of age.

Lipoflex special and other medicines

The patient should tell their doctor, pharmacist, or nurse about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Lipoflex special may interact with other medicines. The patient should inform their doctor, pharmacist, or nurse if they are taking or receiving any of the following medicines:

• insulin,
• heparin,
• medicines that prevent unwanted blood clotting, such as warfarin or other coumarin derivatives,
• diuretics,
• medicines used to treat high blood pressure (ACE inhibitors),
• medicines used to treat high blood pressure or heart disorders (angiotensin II receptor antagonists),
• medicines used in organ transplantation, such as cyclosporine and tacrolimus,
• medicines used to treat inflammation (corticosteroids),
• hormonal medicines that affect fluid balance (adrenocorticotropic hormone or ACTH).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. If the patient is pregnant, they will only receive this medicine if their doctor or pharmacist considers it absolutely necessary for their recovery. There is no available data on the use of Lipoflex special in pregnant women.
Breastfeeding is not recommended for mothers receiving parenteral nutrition.

Driving and using machines

This medicine is usually given to bedridden patients, e.g., in a hospital or clinic, which excludes driving and using machines. However, the medicine itself does not affect the ability to drive and use machines.

Lipoflex special contains sodium

The medicine contains 771 mg of sodium (the main component of common salt) in each 625 ml bag.
This corresponds to 39% of the maximum recommended daily intake of sodium in the diet for adults.
The maximum recommended daily dose of this medicinal product contains 3020 mg of sodium (the main component of common salt). This corresponds to 151% of the maximum recommended daily intake of sodium in the diet for adults.
If one or more bags are taken per day for a long time, patients, especially those controlling their sodium intake, should consult their doctor or pharmacist.

3. How to use Lipoflex special

The medicine is given as an intravenous infusion (drip), i.e., through a small tube directly into a vein. The medicine is only given into larger (central) veins.
The doctor or pharmacist will determine the dose and decide how long to use the medicine.

Use in children

This medicine must not be given to newborns, infants, and children under 2 years of age.
The doctor will decide how much of this medicine the child needs and how long they will need treatment with this medicine.

Using more than the recommended dose of Lipoflex special

If too much of this medicine is received, the patient may experience a so-called overload syndrome with the following symptoms:

• excess fluid in the body and electrolyte imbalance,
• fluid in the lungs (pulmonary edema),
• loss of amino acids in the urine and disturbed amino acid balance,
• vomiting, nausea,
• chills,
• high blood sugar levels,
• glucose in the urine,
• fluid deficiency,
• significantly higher than normal levels of blood components (hyperosmolality),
• disorder or loss of consciousness due to very high blood sugar levels,
• enlargement of the liver (hepatomegaly) with or without jaundice,
• enlargement of the spleen (splenomegaly),
• fat deposition in internal organs,
• abnormal liver function test results,
• decreased red blood cell count (anemia),
• decreased white blood cell count (leukopenia),
• decreased platelet count (thrombocytopenia),
• increased number of immature red blood cells (reticulocytosis),
• red blood cell breakdown (hemolysis),
• bleeding or tendency to bleed,
• blood clotting disorders (expressed as changes in bleeding time, clotting time, prothrombin time, etc.),
• fever
• high levels of fat in the blood,
• loss of consciousness.

If any of the above symptoms occur, the infusion should be stopped immediately.
In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

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 you experience any of the following side effects, tell your doctor immediately, who will stop the administration of the medicine:

Rare (may affect up to 1 in 1000 people):

• allergic reactions, such as skin reactions, shortness of breath, swelling of the lips, mouth, and throat, difficulty breathing.

Other side effects include:

Uncommon (may affect up to 1 in 100 people):

• nausea, vomiting, loss of appetite.

Rare (affects 1 to 10 users out of 10,000):

• increased blood clotting,
• bluish discoloration of the skin,
• shortness of breath,
• headache,
• hot flashes,
• redness of the skin (flushing),
• sweating,
• chills,
• feeling cold,
• increased body temperature,
• drowsiness
• chest pain, back pain, bone and lumbar pain,
• decrease or increase in blood pressure.

Very rare (may affect up to 1 in 10,000 people):

• abnormally high levels of fat or sugar in the blood,
• high levels of acidic substances in the blood,
• excessive fat levels can lead to fat overload syndrome; more information on this, see "Using more than the recommended dose of Lipoflex special", section 3. Symptoms usually resolve after stopping the infusion.

Unknown (frequency cannot be estimated from available data)

• decreased white blood cell count (leukopenia),
• decreased platelet count (thrombocytopenia),
• disorders of bile flow (cholestasis).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lipoflex special

Store the medicine in a place out of sight and reach of children.
Do not store above 25°C.
Do not freeze. If the medicine is accidentally frozen, the bag should be discarded.
Store in an outer protective bag to protect from light.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the specified month.

6. Contents of the packaging and other information

What Lipoflex special contains

The active substances in the ready-to-use mixture are:

Other ingredients are: citric acid monohydrate (for pH adjustment), egg lecithin for injection, glycerol, sodium oleate, all-rac-α-tocopherol, and water for injection.

What Lipoflex special looks like and what the packaging contains

The ready-to-use product is an infusion emulsion, i.e., it is administered through a small tube into a vein.
Lipoflex special is supplied in three-chamber bags containing:

• 625 ml (250 ml amino acid solution + 125 ml fat emulsion + 250 ml glucose solution)
• 1250 ml (500 ml amino acid solution + 250 ml fat emulsion + 500 ml glucose solution)
• 1875 ml (750 ml amino acid solution + 375 ml fat emulsion + 750 ml glucose solution)

Figure A
Figure B
Figure A: The multi-chamber bag is packaged in a protective bag. Between the bag and the protective bag, an oxygen absorber and oxygen level indicator are placed; the oxygen absorber is made of a neutral material and contains iron hydroxide.
Figure B: The upper chamber contains glucose solution, the middle chamber contains fat emulsion, and the lower chamber contains amino acid solution.
The glucose and amino acid solutions are clear and colorless or have a straw-like color. The fat emulsion is milky white.
The upper and middle chambers can be connected to the lower chamber by opening the internal welds (breakable welds).
The bag is designed to allow mixing of amino acids, glucose, fats, and electrolytes in one chamber. Breaking the welds will cause sterile mixing of the contents and formation of an emulsion.
The product in different sizes is available in cardboard boxes containing five bags.
Package sizes: 5 x 625 ml, 5 x 1250 ml, and 5 x 1875 ml
Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

• B. Braun Melsungen AG Carl-Braun-Strße 1 Postal address34212 Melsungen, Germany 34209 Melsungen, Germany

Phone: +49-(0)-5661-71-0
Fax: +49-(0)-5661-71-4567

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria
Nutriflex Lipid special B.Braun Emulsion zur Infusion
Belgium
Nutriflex Lipid special, 56 g/l Amino + 144 g/l G, emulsie voor infusie
Denmark
Lipoflex special
Finland
Nutriflex Lipid 56/144/40 infuusioneste, emulsio
France
REANUTRIFLEX E, émulsion pour perfusion
Germany
NuTRIflex Lipid special novo Emulsion zur Infusion
Iceland
Nutriflex Lipid 56/144 special innrennslislyf, fleyti
Italy
LIPOFLEX AA56/ G144 Emulsione per infusione
Luxembourg
NuTRIflex Lipid special novo Emulsion zur Infusion
Netherlands
Nutriflex Lipid special, 56 g/l Amino + 144 g/l G, emulsie voor infusie
Norway
Lipoflex special infusjonsvæske, emulsjon
Poland
Lipoflex special
Spain
Lipoflex special emulsión para perfusión EFG
Sweden
Nutriflex Lipid 56/144/40 infusionsvätska, emulsion
United Kingdom (Northern Ireland) Lipoflex special emulsion for infusion

Date of last revision of the leaflet: 15.11.2023

______________________________________________________________________________
Information intended for healthcare professionals only:
No special requirements for disposal.
Before use, parenteral nutrition products should be visually inspected for damage, discoloration, or instability of the emulsion.
Do not use damaged bags. The outer and inner bag, as well as the welds between the chambers, should be intact. The product should only be used if the amino acid and glucose solutions are clear and colorless to straw-like, and the fat emulsion is homogeneous in a milky white color. Do not use if the solutions contain solid particles.
After mixing the contents of the three chambers, do not use if the emulsion shows discoloration or signs of phase separation (oil droplets, oil layer). In case of emulsion discoloration or signs of phase separation, the infusion should be stopped immediately.
Before opening the protective bag, check the oxygen level indicator (see Figure A). Do not use if the oxygen level indicator has changed color to pink. Use only if the oxygen level indicator is yellow.
Preparation of the mixed emulsion
Strictly follow aseptic handling rules.
To open: tear the protective bag, starting from the notches (Fig. 1). Remove the bag from the protective bag. Remove the protective bag, oxygen level indicator, and oxygen absorber.
Inspect the product bag for any signs of damage. Damaged bags should be discarded due to the lack of guarantee of their sterility.

Mixing the contents of the bag and adding additional substances
To open and mix the contents of the subsequent chambers, roll the bag with both hands, starting from the weld separating the upper chamber (glucose) and the lower chamber (amino acids) (Fig. 2).

After removing the aluminum cover (Fig. 3), compatible, water-soluble additional substances can be added to the clear aqueous solutions through the medication port (Fig. 4). Mix the contents thoroughly (Fig. 5) and inspect for any precipitates in the mixture (Fig. 6). Only use a clear solution.

Then, continue rolling until the weld separating the middle chamber (fats) and the lower chamber is opened (Fig. 7). The mixture is a homogeneous, milky white emulsion of the oil-in-water type. After mixing the contents of all chambers, compatible additional substances can be added through the medication port (Fig. 4). Mix the contents thoroughly (Fig. 8) and inspect the mixture (Fig. 9).

Information on the compatibility of various additional substances (e.g., electrolytes, trace elements, vitamins) and the shelf life of such admixtures can be obtained upon request from the manufacturer.
Preparation for infusion
Before infusion, the emulsion should always be brought to room temperature.
Remove the aluminum foil (Fig. 10) from the infusion port and attach the infusion set (Fig. 11). Use infusion sets without an air vent or close the air vent when using sets with an air vent. Hang the bag on an infusion stand (Fig. 12) and administer the infusion using standard technique.

For single use only. After use, the container and any unused contents should be discarded.
Do not reconnect partially used containers.
If filters are used, they must be fat-permeable (pore size ≥ 1.2 µm).
Shelf life after removal of the protective bag and mixing the contents of the bag
Chemical and physicochemical stability of the mixed amino acid, glucose, and fat emulsion has been demonstrated before use for a period of 7 days at 2-8°C and for an additional 2 days at 25°C.
Shelf life after addition of compatible additional substances
From a microbiological point of view, the product should be used immediately after addition of additional substances.
The user is responsible for the time and conditions of storage before use if the product is not used immediately after addition of additional substances.
The emulsion should be used immediately after opening the container.
The recommended duration of infusion from a single bag for parenteral nutrition is 24 hours.
Do not mix this medicinal product with other medicinal products for which compatibility has not been established.
This medicinal product should not be administered simultaneously with blood through the same infusion set due to the risk of pseudoagglutination.