Lipoflex peri

Package leaflet: Information for the user

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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, 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 side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Lipoflex peri is and what it is used for
2. What you need to know before using Lipoflex peri
3. How to use Lipoflex peri
4. Possible side effects
5. How to store Lipoflex peri
6. Contents of the pack and other information

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

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

2. Important Information Before Using Lipoflex peri

When not to use Lipoflex peri

• 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 blood 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 kidney failure without renal replacement therapy,
• Electrolyte imbalances in the body,
• Fluid deficiency or excess water in the body,
• Pulmonary edema (fluid in the lungs),
• 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 disturbances following surgery or trauma,
  • Coma of unknown origin,
  • Inadequate tissue oxygen supply,
  • Abnormally high levels of acids in the blood.

Warnings and precautions
Before starting treatment with Lipoflex peri, discuss this with your doctor.
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 besides 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 peri and other medicines
Inform your doctor, pharmacist, or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Lipoflex peri 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 peri in pregnant women.
Breastfeeding is not recommended for mothers receiving parenteral nutrition.

Driving and operating machinery
This medicine is usually administered to immobilized patients, e.g., in a hospital or clinic, which excludes driving and operating machinery. However, this medicine has no effect on the ability to drive or operate machinery.

Lipoflex peri contains sodium
This medicine contains 1150 mg of sodium (main component of table salt) in each 1250 ml bag.
This corresponds to 58% of the maximum recommended daily sodium intake in the adult diet.
The maximum recommended daily dose of this medicinal product contains 2580 mg of sodium (main component of table salt). This corresponds to 129% of the maximum recommended daily sodium intake in the adult diet.
Patients who receive one or more bags per day over a prolonged period, especially those monitoring their dietary sodium intake, should consult their doctor or pharmacist.

3. How to use Lipoflex peri

The medicine is administered as an intravenous infusion (drip), meaning through a small tube directly into a vein. The medicine can be given into smaller (peripheral) or larger (central) veins. The dose will be determined by the doctor or pharmacist, who will also decide how long the treatment should last.

Use in children
Lipoflex peri must not be given to newborns, infants, or children under two years of age. The doctor will determine the appropriate dose for a child and how long the treatment should continue.

Administration of a higher than recommended dose of Lipoflex peri
If too high a dose of this medicine is administered, the patient may develop an 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 levels,
• glucose in urine,
• dehydration,
• significantly increased blood osmolality (hyperosmolality),
• impaired or lost consciousness due to very high blood sugar levels,
• liver enlargement (hepatomegaly) with or without jaundice,
• spleen enlargement (splenomegalia),
• 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),
• destruction of red blood cells (hemolysis),
• bleeding or tendency to bleed,
• blood coagulation disorders (manifested as changes in bleeding time, clotting time, prothrombin time, etc.),
• fever,
• high blood fat levels,
• loss of consciousness.

If any of the above symptoms occur, the infusion must be stopped immediately.
If you have any further questions or uncertainties about 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 everybody 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 1,000 people):

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

Other adverse reactions include:
Common (may occur in 1 out of 10 people):

• irritation or inflammation of the veins (phlebitis, thrombophlebitis).

Uncommon (may occur in 1 out of 100 people):

• nausea, vomiting, loss of appetite.

Rare (may occur in 1 out of 1,000 people):

• increased blood coagulation,
• bluish discoloration of the skin,
• shortness of breath,
• headache,
• hot flushes,
• redness of the skin (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 “Use of a higher than recommended dose of Lipoflex peri”, section 3. 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),
• disorders of bile flow (cholestasis).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, tell your doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring of 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.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Lipoflex peri

Keep this medicine out of sight and reach of children.
Do not store above 25°C.
Do not freeze. If accidentally frozen, 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 package and other information

What Lipoflex peri 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
injection, glycerol, sodium oleate, all-rac-α-Tocopherol and water for injection.
What Lipoflex peri looks like and contents of the pack
The ready-to-administer product is an infusion emulsion, i.e. it is administered through a small tube into
a vein.
Lipoflex peri is supplied in three-compartment bags containing:

• 1250 ml (500 ml amino acid solution + 250 ml lipid emulsion + 500 ml glucose solution)
• 1875 ml (750 ml amino acid solution + 375 ml lipid emulsion + 750 ml glucose solution)
• 2500 ml (1000 ml amino acid solution + 500 ml lipid emulsion + 1000 ml glucose solution)

Figure A Figure B
Figure A: The multi-compartment bag is packed in a protective overwrap. An oxygen absorber and an oxygen indicator are placed between the bag and the protective overwrap; the oxygen-absorbing sachet is made of inert material and contains iron hydroxide.
Figure B: The upper compartment contains the glucose solution, the middle compartment contains the lipid emulsion, and the lower compartment contains the amino acid solution.
The glucose and amino acid solutions are clear and colourless or slightly yellowish. The lipid emulsion is milky white.
The upper and middle compartments can be connected with the lower compartment by opening the internal seals (breakable seals).
The bag is designed to allow mixing of amino acids, glucose, lipids and electrolytes in one compartment. Breaking the seals will result in sterile mixing of the contents and formation of an emulsion.
The product in different container sizes is available in cardboard packs containing five bags.
Pack sizes: 5 x 1250 ml, 5 x 1875 ml and 5 x 2500 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 Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria Nutriflex Lipid peri B.Braun Emulsion zur Infusion
Belgium Nutriflex Lipid peri, 32 g/l Amino + 64 g/l G, emulsie voor infusie
Denmark Lipoflex peri
Finland Nutriflex Lipid 32/64/40 perifer infuusioneste, emulsio
Germany NuTRIflex Lipid peri novo Emulsion zur Infusion
Iceland Nutriflex Lipid 32/64 peri innrennslislyf, fleyti
Italy LIPOFLEX AA32/G64 Emulsione per infusione
Luxembourg NuTRIflex Lipid peri novo Emulsion zur Infusion
Netherlands Nutriflex Lipid peri, 32 g/l Amino + 64 g/l G, emulsie voor infusie
Norway Lipoflex peri infusjonsvæske, emulsjon
Poland Lipoflex peri
Romania NuTRIflex Lipid peri novo, emulsie perfuzabilă
Spain Lipoflex peri emulsión para perfusión EFG
Sweden Nutriflex Lipid 32/64/40 perifer infusjonsvæske, emulsjon
United Kingdom (Northern Ireland) Lipoflex peri emulsion for infusion
______________________________________________________________________________

Information intended exclusively for healthcare 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 straw-colored, and the fat emulsion is homogeneous with a milky white appearance. Do not use if the 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). In case of emulsion discoloration or signs of phase separation,
infusion must be immediately discontinued.
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
Strict aseptic handling procedures must be followed.
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 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 with breaking 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 to the clear aqueous solutions via the medication port (Fig. 4). Mix the contents thoroughly (Fig. 5) and inspect the mixture for precipitates (Fig. 6). Only use clear solutions.

Then continue applying pressure until the seal separating the middle compartment (fats) and lower compartment is opened (Fig. 7).
The mixture is a milky white, homogeneous 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 on compatibility of various additional substances (e.g., electrolytes, trace elements, vitamins) and 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 technique.

For single use only. After use, the container and any unused remnants 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 bag contents
Chemical and physicochemical stability of the mixture of amino acids, glucose, and fat emulsion has been demonstrated for 7 days 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 addition of 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 for which compatibility has not been confirmed.
This medicinal product must not be administered simultaneously with blood through the same infusion set due to the risk of pseudoagglutination.