Lipoflex special

Package leaflet: Information for the user

Lipoflex special, infusion emulsion
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

1. What Lipoflex special is and what it is 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 pack and other information

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

Lipoflex special contains fluids and substances including amino acids, electrolytes, and fatty acids.
These are essential for body growth or regeneration. It also provides calories in the form of
carbohydrates and fats.
This medicine is administered to patients who are unable to receive nutrition orally. There are many
situations in which this may occur, for example, in the postoperative, post-traumatic, or post-burn period, 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, soy, or any of the other ingredients of this medicine (listed in section 6).
• This medicine must not be given to newborns, infants, or children under two years of age.

This medicine should also not be used in the following cases:

• Life-threatening circulatory disorders occurring during collapse or shock,
• Myocardial infarction or stroke,
• Severe coagulation disorders, risk of bleeding (severe coagulopathy, exacerbation of hemorrhagic diathesis),
• Blockage of blood vessels by blood clots or fat (embolism),
• Severe liver failure,
• Impaired bile flow (intrahepatic cholestasis),
• Severe renal failure without renal replacement therapy,
• Electrolyte imbalances in the body,
• Fluid deficiency or excess water in the body,
• Fluid in the lungs (pulmonary edema),
• Severe heart failure,
• Certain metabolic disorders, such as:
  • Excessively high levels of fats in the blood,
  • Inborn errors of amino acid metabolism,
  • Abnormally high blood sugar levels requiring more than 6 units of insulin per hour,
  • Metabolic disorders occurring after surgery or trauma,
  • Coma of unknown origin,
  • Inadequate tissue oxygenation,
  • Abnormally high acid levels in the blood.

Warnings and precautions
Before starting treatment with Lipoflex special, discuss this with your doctor, pharmacist, or nurse.
Inform your doctor if:

• The patient has heart, liver, or kidney disorders,
• The patient has specific metabolic disorders such as diabetes, abnormal blood lipid levels, or disturbances in fluid and electrolyte balance or acid-base equilibrium.

While receiving this medicine, the patient will be closely monitored for early signs of allergic reactions (such as fever, chills, rash, or shortness of breath).
Additional monitoring and laboratory tests, including various blood analyses, will be performed to ensure the patient's body is properly handling the administered nutrients.
The nursing staff may take measures to ensure the patient's body receives adequate fluids and electrolytes. The patient may receive additional nutritional components alongside this medicine to fully meet the body's nutritional requirements.

Children
This medicine must not be given to newborns, infants, or children under two years of age.

Lipoflex special and other medicines
Tell your doctor, pharmacist, or nurse about all medicines the patient is currently taking, has recently taken, or plans to take.
Lipoflex special may interact with other medicines. The patient should inform the doctor, pharmacist, or nurse if they are taking or receiving any of the following medicines:

• Insulin,
• Heparin,
• Medicines preventing unwanted blood clotting, such as warfarin or other coumarin derivatives,
• Medicines that increase urine production (diuretics),
• Medicines used for high blood pressure (ACE inhibitors),
• Medicines used for high blood pressure or heart disorders (angiotensin II receptor antagonists),
• Medicines used in organ transplantation, such as cyclosporine and tacrolimus,
• Medicines used to treat inflammatory conditions (corticosteroids),
• Hormonal medicines affecting fluid balance (adrenocorticotropic hormone or ACTH).

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

Driving and operating machinery
This medicine is usually administered to immobilized patients, for example in hospital or clinic settings, which excludes driving and operating machinery. However, the medicine itself does not affect the ability to drive or operate machinery.

Lipoflex special contains sodium
This medicine contains 771 mg of sodium (main component of table salt) in each 625 ml bag.
This corresponds to 39% of the maximum recommended daily dietary sodium intake for adults.
The maximum recommended daily dose of this medicinal product contains 3020 mg of sodium (main component of table salt). This corresponds to 151% of the maximum recommended daily dietary sodium intake for adults.
If one or more bags per day are administered over a prolonged period, patients, especially those monitoring their dietary sodium intake, should consult their doctor or pharmacist.

3. How to use Lipoflex special

This medicine is administered as an intravenous infusion (drip), through a small tube directly into a vein. The medicine is administered exclusively into larger (central) veins.
The dose and duration of treatment will be determined by the doctor or pharmacist.
Use in children
This medicine must not be given to newborns, infants, or children under two years of age.
The doctor will decide how much of this medicine the child needs and for how long treatment should continue.
Administration of a higher than recommended dose of Lipoflex special
If too much of this medicine is administered, the patient may develop so-called overload syndrome with the following symptoms:

• fluid overload and electrolyte imbalance,
• pulmonary edema (fluid in the lungs),
• loss of amino acids in urine and disturbed amino acid balance,
• vomiting, nausea,
• chills,
• high blood sugar concentration,
• glucose in urine,
• fluid deficiency,
• significantly higher than normal blood osmolality (hyperosmolality),
• impaired or lost consciousness due to very high blood sugar concentration,
• enlarged liver (hepatomegaly) with or without jaundice,
• enlarged spleen (splenomegia),
• fat deposition in internal organs,
• abnormal liver function test results,
• reduced number of red blood cells (anemia),
• reduced number of white blood cells (leukopenia),
• reduced number of platelets (thrombocytopenia),
• increased number of immature red blood cells (reticulocytosis),
• breakdown of red blood cells (hemolysis),
• bleeding or tendency to bleed,
• coagulation disorders (manifested by changes in bleeding time, clotting time, prothrombin time, etc.),
• fever,
• high blood fat concentration,
• loss of consciousness.

If any of the above symptoms occur, the infusion must be stopped immediately.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may be serious. If any of the following adverse reactions occur,
inform your doctor immediately, who will discontinue the medicine:
Rare (may occur in 1 out of 1000 people):

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

Other adverse reactions include:
Uncommon (may occur in 1 out of 100 people):

• nausea, vomiting, loss of appetite.

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

• increased blood coagulation,
• bluish discoloration of the skin,
• shortness of breath,
• headache,
• hot flushes,
• skin redness (erythema),
• sweating,
• chills,
• feeling cold,
• elevated body temperature,
• drowsiness,
• chest pain, back pain, bone pain and lower back pain,
• decrease or increase in blood pressure.

Very rare (may occur in 1 out of 10,000 people):

• abnormally high levels of fat or sugar in the blood,
• high levels of acidic substances in the blood,
• excessively high levels of fats may lead to fat overload syndrome; more information on this, see section 3. "Overdose of Lipoflex special", symptoms usually resolve after discontinuation of the infusion.

Not known (frequency cannot be estimated from the available data):

• decreased number of white blood cells (leukopenia),
• decreased number of platelets (thrombocytopenia),
• disturbances in bile flow (cholestasis).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this
leaflet, inform your doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Lipoflex special

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not freeze. If accidental freezing occurs, the bag must be discarded.
Store in the 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 stated month.

6. Contents of the pack and other information

What Lipoflex special contains
The active substances contained in the ready-to-use mixture are:

The other ingredients are: citric acid monohydrate (for pH adjustment), egg phospholipids for injections, glycerol, sodium oleate, all-rac-α-tocopherol and water for injections.
What Lipoflex special looks like and contents of the pack
The ready-to-use product is an emulsion for infusion, meaning it is administered through a small tube into a vein.
Lipoflex special is supplied in three-compartment 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 packed in a protective overwrap. Between the bag and the protective overwrap, an oxygen absorber and an oxygen indicator are placed; the oxygen-absorbing sachet is made of inert 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, colourless or slightly yellow. The fat emulsion is milky white.
The upper and middle chambers can be connected to the lower chamber by opening the internal seals (breakable seals).
The bag is designed to allow mixing of amino acids, glucose, fats and electrolytes in one chamber. Breaking the seals results in sterile mixing of the contents and formation of an emulsion.
The product is available in different container sizes, packed in cardboard boxes containing five bags.
Pack sizes: 5 x 625 ml, 5 x 1250 ml and 5 x 1875 ml
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
B. Braun Melsungen AG
Carl-Braun-Strasse 1 Postal address
34212 Melsungen, Germany 34209 Melsungen, Germany
Tel.: +49-(0)-5661-71-0
Fax: +49-(0)-5661-71-4567
This medicinal product is authorised in the European Economic Area and 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
______________________________________________________________________________

Information intended exclusively for medical professionals:

No special requirements for disposal.
Before use, parenteral nutrition products should be visually inspected for damage, discoloration, or emulsion instability.
Do not use bags that are damaged. The outer and inner bag, as well as the seals between compartments, must be intact. The product should be used only if amino acid and glucose solutions are clear and colorless to pale yellow, and the fat emulsion is uniform and milky white in appearance. Do not use if solutions contain particulate matter.
After mixing the contents of the three compartments, do not use if the emulsion shows discoloration or signs of phase separation (oil droplets, oil layer). If discoloration or phase separation occurs, infusion must be stopped immediately.
Before opening the protective packaging, check the oxygen indicator (see Figure A). Do not use if the oxygen indicator has changed color to pink. Use only if the oxygen indicator is yellow.

Preparation of the mixed emulsion
Strictly follow aseptic handling procedures.
To open: tear the protective packaging starting at the perforation points (Fig. 1). Remove the bag from the protective packaging. Remove the protective packaging, oxygen indicator, and oxygen absorber. Inspect the product bag for leaks. Leaking bags must be discarded due to lack of sterility assurance.

Mixing the bag contents and adding additional substances
To open and mix the contents of the compartments, fold the bag with both hands, starting by opening the seal separating the upper compartment (glucose) and lower compartment (amino acids) (Fig. 2).

After removing the aluminum cover (Fig. 3), compatible, water-soluble additional substances may be added into the clear aqueous solutions via the medication port (Fig. 4). Mix the contents thoroughly (Fig. 5) and inspect the mixture for precipitates (Fig. 6). Use only clear solutions.

Next, continue applying pressure until the seal separating the middle compartment (fats) and the lower compartment is opened (Fig. 7). The mixture forms a uniform, milky white oil-in-water emulsion. After mixing all compartments, compatible additional substances may be added via the medication port (Fig. 4). Mix the contents thoroughly (Fig. 8) and inspect the mixture (Fig. 9).

Information regarding compatibility of various additional substances (e.g., electrolytes, trace elements, vitamins) and the shelf life of such admixtures is available upon request from the manufacturer.

Preparation for infusion
Before infusion, always bring the emulsion 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 if using sets with an air vent, ensure the vent is closed. Hang the bag on an infusion stand (Fig. 12) and administer the infusion using standard techniques.

For single use only. After use, the container and any unused residues must 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 protective packaging and mixing of bag contents
Chemical and physicochemical stability of the mixture of amino acids, glucose, and fat emulsion has been demonstrated for 7 days when stored at 2–8°C and for an additional 2 days at 25°C prior to use.

Shelf life after addition of compatible additional substances
From a microbiological standpoint, the product should be used immediately after addition of additional substances. The user is responsible for the storage time and conditions prior to use if the product is not used immediately after adding additional substances.
The emulsion should be used immediately after opening the container.

The recommended duration of infusion from a single bag in parenteral nutrition is 24 hours.
Do not mix this medicinal product with other medicinal products unless compatibility has been confirmed.
This medicinal product must not be administered simultaneously with blood through the same infusion set due to the risk of pseudoagglutination.