LIPOFLEX SPECIAL WITHOUT ELECTROLYTES EMULSION FOR INFUSION

2. What you need to know before starting to use Lipoflex special without electrolytes

Do not useLipoflex special without electrolytes

? if you are allergic to any of the active substances, egg, peanut, or soy, or any of the other components of this medication (listed in section 6),

? this medication should not be administered to newborns, infants, and children under two years of age.

Also, do not use this medication if you have any of the following disorders:

? potentially life-threatening blood circulation problems, such as those that can occur in cases of collapse or shock,

? myocardial infarction or stroke,

? severe blood coagulation disorders, risk of bleeding (severe coagulopathy, hemorrhagic diathesis),

? blockage of blood vessels by blood clots or fat (embolism),

? severe liver failure,

? altered bile flow (intrahepatic cholestasis),

? severe kidney failure where dialysis equipment is not available,

? alterations in the composition of body salts,

? fluid deficit or excess water in your body,

? water in your lungs (pulmonary edema),

? severe heart failure,

? certain metabolic disorders, such as:

• excessive lipids (fats) in the blood,
• congenital disorders of amino acid metabolism,
• abnormally high blood sugar levels that require more than 6 units of insulin per hour to be controlled,
• metabolic disorders that can occur after surgical interventions or trauma,
• coma of unknown origin,
• insufficient oxygen supply to tissues,
• abnormally high acid levels in the blood.

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to use Lipoflex special without electrolytes.

Inform your doctor if:

? you have heart, liver, or kidney problems,

? you have certain types of metabolic disorders, such as diabetes, abnormal blood fat values, and disorders of body fluid and salt composition or acid-base balance.

You will be closely monitored to detect the first signs of an allergic reaction (such as fever, chills, skin rash, or shortness of breath) when you receive this medication.

Additional monitoring and tests, such as various blood sample tests, will be performed to ensure that your body is adequately assimilating the administered nutrients.

This medication is an electrolyte-free solution. Healthcare personnel may also take measures to ensure that your body's fluid and electrolyte needs are met. In addition to Lipoflex special without electrolytes, you may receive additional nutrients (food) to fully meet your needs.

Children

This medication should not be administered to newborns, infants, or children under two years of age.

Use ofLipoflex special without electrolyteswith other medications

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or may take any other medication.

Lipoflex special without electrolytes may interact with some medications. Inform your doctor, pharmacist, or nurse if you are taking or receiving any of the following medications:

? insulin,

? heparin,

? medications that prevent unwanted blood coagulation, such as warfarin or other coumarin derivatives.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. If you are pregnant, you will receive this medication only if your doctor or pharmacist considers it absolutely necessary for your recovery. There are no available data on the use of Lipoflex special without electrolytes in pregnant women.

Breastfeeding is not recommended in mothers treated with parenteral nutrition.

Driving and Using Machines

This medication is usually administered to patients who are immobilized, e.g., in a hospital or clinic, which excludes the possibility of driving or using machines. However, this medication itself does not affect the ability to drive or use machines.

Lipoflex special without electrolytescontains sodium.

This medication contains less than 1 mmol of sodium (23 mg) per multi-chamber bag; i.e., it is essentially "sodium-free".

3. How to use Lipoflex special without electrolytes

This medication is administered through intravenous infusion (drop by drop), i.e., through a small tube directly into a vein. This medication will only be administered through one of your large veins (central veins).

Your doctor or pharmacist will decide what amount of this medication you need and for how long you need treatment with it.

Use in Children

This medication should not be administered to newborns, infants, or young children under two years of age.

Your doctor will decide what amount of this medication your child needs and for how long your child requires treatment with this medication.

If you use moreLipoflex special without electrolytesthan you should

If you have received too much of this medication, you may suffer from the so-called "overload syndrome" and the following symptoms:

? excess fluids and electrolyte disturbances,

? water in your lungs (pulmonary edema),

? loss of amino acids through urine and disturbances in amino acid balance,

? vomiting, nausea,

? chills,

? high blood sugar levels,

? glucose in urine,

? fluid deficit,

? highly concentrated blood (hyperosmolality),

? altered or lost consciousness due to extremely high blood sugar levels,

? liver enlargement (hepatomegaly) with or without jaundice,

? spleen enlargement (splenomegaly),

? fat deposits in internal organs,

? abnormal liver function test values,

? reduced red blood cell count (anemia),

? reduced white blood cell count (leukopenia),

? reduced platelet count (thrombocytopenia),

? increased immature red blood cells (reticulocytosis),

? blood cell rupture (hemolysis),

? bleeding or tendency to bleed,

? blood coagulation disorders (as can be seen by changes in bleeding time, coagulation time, prothrombin time, etc.),

? fever,

? high blood fat levels,

? loss of consciousness.

If any of the following occur, the infusion should be interrupted immediately.

If you have any further questions on the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone gets them.

The following side effects can be serious. If you experience any of the following side effects, inform your doctor immediately, who will stop administering this medication:

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

? increased tendency to blood coagulation,

? bluish discoloration of the skin,

? shortness of breath,

? headache,

? flushing,

? skin redness (erythema),

? sweating,

? chills,

? feeling of cold,

? high body temperature,

? drowsiness,

? pain in the chest, back, bones, or lumbar region,

? decreased or increased blood pressure.

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

? abnormally high blood sugar or fat levels,

? high levels of acidic substances in your blood,

? an excess of lipids can cause overload syndrome; for more information, see the heading "If you use more Lipoflex special without electrolytes than you should" in section 3. Symptoms usually disappear when the infusion is interrupted.

Frequency not known (cannot be estimated from available data):

? reduced white blood cell count (leukopenia),

? reduced platelet count (thrombocytopenia),

? bile flow disorders (cholestasis).

Reporting Side Effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this package leaflet.

You can also report them directly through the Spanish Medicines Agency's online platform (www.notificaRAM.es).

5. Storage of Lipoflex special without electrolytes

Keep this medication out of the sight and reach of children.

Do not store above 25°C.

Do not freeze. Discard the bag if it has been accidentally frozen.

Keep the bag in the outer packaging to protect it from light.

Do not use this medication after the expiration date stated on the label. The expiration date is the last day of the month indicated.

6. Container Content and Additional Information

Composition ofLipoflex special without electrolytes

The active principles of the ready-to-use mixture are:

The other components are citric acid monohydrate (for pH adjustment), injectable egg phospholipids, glycerol, sodium oleate, all-rac-alpha-tocopherol, and water for injectable preparations.

Appearance of the product and container content

The ready-to-use product is an emulsion for infusion, i.e., it is administered through a small tube in a vein.

Lipoflex special without electrolytes is supplied in flexible multi-chamber bags containing:

• 625 ml (250 ml of amino acid solution + 125 ml of fat emulsion + 250 ml of glucose solution),
• 1,250 ml (500 ml of amino acid solution + 250 ml of fat emulsion + 500 ml of glucose solution),
• 1,875 ml (750 ml of amino acid solution + 375 ml of fat emulsion + 750 ml of glucose solution).

Figure A Figure B

Figure A: The multi-chamber bag is inserted into a protective wrapper. Between the bag and the wrapper are an oxygen absorber and an oxygen indicator; the oxygen absorber wrapper is made of an inert material and contains iron hydroxide.

Figure B: The upper chamber contains a glucose solution, the middle chamber contains a fat emulsion, and the lower chamber contains an amino acid solution.

The glucose and amino acid solutions are clear and colorless to pale yellow. The fat emulsion is white and milky.

The upper and middle chambers can be connected to the lower chamber by opening the intermediate seams (peelable seams).

The bag design allows for the mixing of amino acids, glucose, and lipids in a single chamber. When the peelable seams are opened, a sterile mixture is formed that creates an emulsion.

The different package sizes are presented in boxes containing five bags.

Package sizes: 5 x 625 ml, 5 x 1,250 ml, and 5 x 1,875 ml.

Only some package sizes may be marketed.

Marketing authorization holder:

• Braun Melsungen AG

Carl-Braun-Str. 1 Mailing address:

34212 Melsungen, Germany 34209 Melsungen, Germany

Tel.: +49-(0)-5661-71-0

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

Manufacturer:

• BRAUN MELSUNGEN AG

Am Schwerzelshof 1

34212 Melsungen, Germany

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191 Rubí, Spain

This medicinal product is authorized in the Member States of the European Economic Areaand in the United Kingdom (Northern Ireland)with the following names:

Austria Nutriflex Lipid special ohne Elektrolyte B.Braun

Belgium Nutriflex Lipid special EF, 56 g/l AA + 144 g/l G, emulsie voor infusie

France LIPOFLEX LIPIDE G144/N8, émulsion pour perfusion

Germany Nutriflex Lipid 56/144 special ohne Elektrolyte

Italy Lipoflex, AA56/G144 senza elettroliti

Luxembourg Nutriflex Lipid 56/144 special without electrolytes

Netherlands Nutriflex Lipid special zonder elektrolyten, 56 g/l + 144 g/l, emulsie voor infusie

Spain Lipoflex special sin electrolitos emulsión para perfusión

United Kingdom

(Northern Ireland) Lipoflex special without electrolytes emulsion for infusion

Date of the last revision of this leaflet:

09/2023

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

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This information is intended exclusively for healthcare professionals:

No special requirements are needed for disposal.

Parenteral nutrition products should be visually inspected before use for damage, color changes, and emulsion instability.

Do not use damaged bags. The wrapper, main bag, and peelable seams between the chambers must be intact. Use only if the amino acid and glucose solutions are clear and colorless to pale yellow and if the lipid emulsion is homogeneous and has a white, milky color. Do not use if the solutions contain particles.

After mixing the three chambers, do not use if the emulsion shows a color change or signs of phase separation (oil droplets, oil layer). Stop the infusion immediately in case of a color change in the emulsion or signs of phase separation.

Before opening the wrapper, check the color of the oxygen indicator (see Figure A). Do not use if the oxygen indicator changes to a pink color. Use only if the oxygen indicator is yellow.

Preparation of the mixed emulsion

A strict adherence to the principles of aseptic handling must be observed.

For opening: open the wrapper starting from the tear-off notches (Fig. 1). Remove the bag from its protective wrapper. Discard the wrapper, oxygen indicator, and oxygen absorber.

Visually inspect the main bag for leaks. Bags with leaks must be discarded, as their sterility cannot be guaranteed.

Mixing the bag and adding additives

To open and mix the chambers sequentially, roll the bag with both hands, first opening the peelable seam that separates the upper chamber (glucose) from the lower chamber (amino acids) (Fig. 2).

After removing the aluminum foil (Fig. 3), it is possible to add compatible hydro-soluble additives through the medication port (Fig. 4) to the clear aqueous solutions. Mix the bag contents well (Fig. 5) and visually inspect the mixture for precipitates (Fig. 6). The solution should only be used if it is transparent.

Then, continue to apply pressure so that the peelable seam that separates the middle chamber (lipids) from the lower chamber (Fig. 7) opens. The mixture is a homogeneous oil-in-water emulsion with a white, milky color. Once all the chambers have been mixed, it is possible to add compatible additives through the medication port (Fig. 4). Mix the bag contents well (Fig. 8) and visually inspect the mixture (Fig. 9).

The manufacturer may provide, upon request, data on the compatibility of different additives (e.g., electrolytes, trace elements, vitamins) and the corresponding validity periods of these mixtures.

Preparation for infusion

The emulsion should always be brought to room temperature before infusion.

Remove the aluminum foil (Fig. 10) from the infusion port and connect the infusion equipment (Fig. 11). Use a non-ventilated infusion set or close the air vent if a ventilated set is used. Hang the bag from an infusion hook (Fig. 12) and perform the infusion according to the standard technique.

For single use. The container and unused residues must be disposed of after use.

Do not reconnect partially used containers.

If filters are used, they must be lipid-permeable (pore size ≥ 1.2 µm).

Validity period after removing the protective wrapper and after mixing the bag contents

Chemical and physicochemical stability of the amino acid, glucose, and lipid mixture has been demonstrated during use for 7 days at 2-8°C and for 2 additional days at 25°C.

Validity period after additional mixing of compatible additives

From a microbiological point of view, the product must be used immediately after the additional mixing of additives. Otherwise, the storage times and conditions before use are the responsibility of the user.

The emulsion must be used immediately after opening the container.

The recommended duration for the infusion of a parenteral nutrition bag is a maximum of 24 hours.

This medicinal product must not be mixed with other medicinal products whose compatibility has not been documented.

This medicinal product must not be administered simultaneously with blood in the same infusion equipment due to the risk of pseudoagglutination.