OMEGAFLEX Emulsion

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Omegaflex special without electrolytes
3. Infusion emulsion
4. You should carefully read the contents of the leaflet before using the medicine, as it contains
   1. Table of contents of the leaflet
5. What is Omegaflex special without electrolytes and what is it used for
6. Important information before using Omegaflex special without electrolytes
   1. When not to use Omegaflex special without electrolytes
   2. Warnings and precautions
   3. Children
   4. Omegaflex special without electrolytes and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Omegaflex special without electrolytes contains sodium
7. How to use Omegaflex special without electrolytes
   1. Use in children
   2. Using more than the recommended dose of Omegaflex special without electrolytes
8. Possible side effects
   1. The following side effects may be serious. If you experience any of the following side effects, you should immediately tell your doctor, who will stop the administration of the medicine to the patient:
   2. Other side effects:
   3. Reporting side effects
9. How to store Omegaflex special without electrolytes
10. Contents of the packaging and other information
    1. What Omegaflex special without electrolytes contains
    2. What Omegaflex special without electrolytes looks like and what the packaging contains
    3. Marketing authorization holder
    4. Manufacturer
    5. This medicine is authorized for marketing in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
    6. Date of last revision of the leaflet: 2024-01-19

Leaflet attached to the packaging: information for the user

Omegaflex special without electrolytes

Infusion emulsion

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

important information for the patient.

• –You should keep this leaflet, so that you can read it again if you need to.
• –If you have any doubts, you should 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 another person, even if their symptoms are the same.
• –If the patient experiences any side effects, including any side effects 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 Omegaflex special without electrolytes and what is it used for
• 2. Important information before using Omegaflex special without electrolytes
• 3. How to use Omegaflex special without electrolytes
• 4. Possible side effects
• 5. How to store Omegaflex special without electrolytes
• 6. Contents of the packaging and other information

1. What is Omegaflex special without electrolytes and what is it used for

Omegaflex special without electrolytes contains fluids and substances called amino acids and fatty acids, which are necessary for the growth of the body or for recovery. It also contains calories in the form of carbohydrates and fats.
Omegaflex special without electrolytes is indicated for use in adults, adolescents, and children over two years of age.
The patient receives Omegaflex special without electrolytes if they cannot normally take food. This may happen in many situations, for example, when the patient is recovering from surgery, injuries, or burns, or when they cannot absorb food from the stomach and intestines.

2. Important information before using Omegaflex special without electrolytes

When not to use Omegaflex special without electrolytes

• –if the patient is allergic to any active substance, eggs, peanuts, soy, fish, or any of the excipients of this medicine (listed in section 6);
• –this medicine must not be given to newborns, infants, and young children under two years of age.

Omegaflex special without electrolytes must not be used if the patient has any of the following conditions:

• life-threatening circulatory disorders, such as those occurring in shock or collapse;
• heart attack or stroke;
• severe coagulation disorders, bleeding risk (severe coagulopathy, worsening bleeding disorders);
• blockage of blood vessels by blood clots or fat (thrombosis);
• severe liver failure;
• disorders of bile flow (intrahepatic cholestasis);
• severe kidney failure in the absence of renal replacement therapy;
• electrolyte imbalance;
• fluid or water deficit in the body;
• fluid in the lungs (pulmonary edema);
• severe heart failure;
• certain metabolic disorders, such as
• –excessive fat (lipids) in the blood,
• –congenital amino acid metabolism disorders,
• –abnormally high blood sugar levels requiring more than 6 units of insulin per hour,
• –metabolic disorders that may occur after surgical procedures or injuries,
• –coma of unknown origin,
• –inadequate tissue oxygenation,
• –abnormally high levels of acidic substances in the blood.

Warnings and precautions

Before starting treatment with Omegaflex special without electrolytes, the patient should discuss it with their doctor.
The patient should tell their doctor if:

• –they have heart, liver, or kidney problems;
• –they have certain metabolic disorders, such as diabetes, abnormal fat levels in the blood, and disorders of fluid and electrolyte balance or acid-base balance.

During treatment with this medicine, the patient will be closely monitored to detect early signs of an allergic reaction (such as fever, chills, rash, or shortness of breath).
To ensure that the patient's body is properly processing the administered nutrients, further observations and tests will be performed, such as various blood sample tests.
This medicine is an electrolyte-free solution. Medical staff will also take measures to ensure that the body's needs for fluids and electrolytes are met.
In addition to Omegaflex special without electrolytes, the patient may also receive other nutrients to fully meet their needs.

Children

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

Omegaflex special without electrolytes and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Omegaflex special without electrolytes may interact with some other medicines.
The patient should tell their doctor 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.

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 before using this medicine. If the patient is pregnant, they will only receive this medicine if their doctor considers it absolutely necessary for their treatment. There is no data on the use of Omegaflex special without electrolytes in pregnant women.
Breastfeeding is not recommended for mothers receiving parenteral nutrition.

Driving and using machines

This medicine is usually given to patients who are bedridden 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.

Omegaflex special without electrolytes contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per multi-chamber bag, which means it is considered "sodium-free".

3. How to use Omegaflex special without electrolytes

This medicine is given by intravenous infusion (drip), i.e., through a thin tube directly into a vein. This medicine will be administered exclusively through one of the large (central) veins. The recommended infusion time for a single bag of emulsion for parenteral nutrition is a maximum of 24 hours.
The doctor will decide how much of this medicine the patient needs and how long they will need treatment with this medicine.

Use in children

This medicine must not be given to newborns, infants, and young children under two 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 Omegaflex special without electrolytes

If the patient receives too much of this medicine, they may experience an overload syndrome and the following symptoms may occur:

• excess fluid and electrolyte disturbances;
• fluid in the lungs (pulmonary edema);
• loss of amino acids in the urine and disturbances of amino acid balance;
• vomiting, nausea;
• chills;
• increased blood sugar levels;
• glucose in the urine;
• fluid deficit;
• significantly higher levels of blood components than normal (hyperosmolality);
• disturbances or loss of consciousness due to extremely 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);
• breakdown of blood cells (hemolysis);
• bleeding or tendency to bleed;
• coagulation disorders (which can be determined by changes in bleeding time, clotting time, prothrombin time, etc.);
• fever;
• increased fat levels in the blood;
• loss of consciousness.

If any of these symptoms occur, the infusion should be stopped immediately.

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, you should immediately tell your doctor, who will stop the administration of the medicine to the patient:

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, and respiratory disorders.

Other side effects:

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

• nausea, vomiting, loss of appetite

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

• increased tendency to blood clotting,
• blue discoloration of the skin,
• shortness of breath,
• headache,
• hot flashes,
• redness of the skin (flushing),
• 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 levels of fat or sugar in the blood,
• high levels of acidic substances in the blood,
• excessive fat can lead to a fat overload syndrome. More information on this can be found in section 3 "Using more than the recommended dose of Omegaflex special without electrolytes". Symptoms usually resolve after the infusion is stopped.

Not known (frequency cannot be estimated from the 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 side effects not listed in this leaflet, you should 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, tel.: 22 49-21-301, fax: 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 Omegaflex special without electrolytes

The medicine should be stored in a place that is 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 the bag in the outer protective bag to protect it 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 month stated.

6. Contents of the packaging and other information

What Omegaflex special without electrolytes contains

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

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

What Omegaflex special without electrolytes looks like and what the packaging contains

The ready-to-use product is an infusion emulsion, i.e., it is an emulsion administered through a thin tube into a vein.
Omegaflex special without electrolytes is supplied in flexible 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 inner bag is packaged in an outer protective bag. Between the inner and outer bags, there is an oxygen absorber and an oxygen indicator; the oxygen absorber 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 solution and amino acid solution are clear and colorless to straw-colored.
The fat emulsion is milky white.
The upper and middle chambers can be connected to the lower chamber by opening the internal welds.
Various package sizes are supplied 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

• B. Braun Melsungen AG Carl-Braun-Straße 1 34212 Melsungen, Germany Tel.: +49-5661-71-0 Fax: +49-5661-71-4567

Manufacturer

• B. Braun Melsungen AG Carl-Braun-Straße 1 34212 Melsungen, Germany

To obtain more detailed information on this medicine, you should contact the representative of the marketing authorization holder in Poland:
Aesculap Chifa sp. z o.o.
ul. Tysiąclecia 14
64-300 Nowy Tomyśl
Phone: +48 61 442 01 00
Fax: +48 61 443 75 05
Email: [email protected]

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

Austria
NuTRIflex Omega special ohne Elektrolyte B.Braun
Belgium
Nutriflex Omega special zonder elektrolyten 56 g/l Amino + 144 g/l G, emulsie voor infusie
Czech Republic
Nutriflex Omega special bez elektrolytů
Denmark
Nutriflex Omega Special elektrolytfri
France
REANUTRIFLEX OMEGA, émulsion pour perfusion
Germany
NuTRIflex Omega special ohne Elektrolyte novo Emulsion zur Infusion
Greece
Nutriflex Omega special without electrolytes
Ireland
Omeflex special without electrolytes emulsion for infusion
Italy
Omegaflex AA38/G120 senza elettroliti
Luxembourg
NuTRIflex Omega special ohne Elektrolyte novo Emulsion zur Infusion
Netherlands
Nutriflex Omega special zonder elektrolyten, 56 g/l Amino + 144 g/l G, emulsie voor infusie
Norway
Nutriflex Omega Special elektrolytfri infusjonsvæske, emulsjon
Poland
Omegaflex special bez elektrolitów
Portugal
Nutriflex Omega S sem eletrólitos emulsão para perfusão
Slovakia
Nutriflex Omega special bez elektrolytov
Spain
Nutriflex Omega special sin electrolitos Emulsión para perfusión
Sweden
Nutriflex Omega 56/144/40 elektrolytfri infusionsvätska, emulsion
United Kingdom (Northern Ireland) Omeflex special without electrolytes emulsion for infusion

Date of last revision of the leaflet: 2024-01-19

Information intended for healthcare professionals only:
Before use, parenteral nutrition products should be visually inspected for any signs of damage, color changes, and emulsion instability.
Do not use damaged bags. The outer and inner bags, 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-colored, and the fat emulsion is homogeneous and milky white in 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). If the emulsion shows discoloration or signs of phase separation, the infusion should be stopped immediately.
Before opening the outer bag, check the color of the oxygen indicator (see Figure A). Do not use if the oxygen indicator has changed color to pink. Only use if the oxygen indicator is yellow.
Preparation of the mixed emulsion
Strictly follow aseptic procedures.
Opening: Tear the outer bag, starting from the tear lines (Fig. 1). Remove the inner bag from the protective packaging. Discard the outer packaging, oxygen indicator, and oxygen absorber.

Visually inspect the inner bag for any signs of leakage.
A leaking bag should be discarded, as sterility cannot be guaranteed.
Mixing the bag contents and adding additional substances
To sequentially open the chambers and mix their contents, roll the bag with both hands, starting from the weld separating the upper chamber (glucose) and the lower chamber (amino acids) (Fig. 2).

Then, continue to press to open the weld separating the middle chamber (fat) and the lower chamber (Fig. 3).

After mixing the contents of all chambers and removing the aluminum foil (Fig. 3A), compatible additives can be added through the drug port (Fig. 4). Thoroughly mix the contents (Fig. 5) and visually inspect the mixture (Fig. 6). The mixture is a homogeneous, milky white emulsion of the oil-in-water type. Any signs of phase separation of the emulsion are not acceptable.

• 3) and visually inspect the mixture (Fig. 6). The mixture is a homogeneous, milky white emulsion of the oil-in-water type. Any signs of phase separation of the emulsion are not acceptable.

Omegaflex special without electrolytes can be mixed with the following additives up to the specified upper limits of concentration or maximum amount of additives after supplementation. The resulting mixtures are stable for 7 days at a temperature of 2°C to 8°C plus 2 days at 25°C.

• Electrolytes: in the three-component mixture, stability has been demonstrated up to a total of 200 mmol/l of sodium + potassium (together), 9.6 mmol/l of magnesium, and 6.4 mmol/l of calcium.
• Phosphate: stability has been demonstrated up to a maximum concentration of 20 mmol/l of inorganic phosphate or up to a maximum concentration of 30 mmol/l of organic phosphate (not both at the same time).
• Alanyl-glutamine up to 24 g/l.
• Trace elements and vitamins: stability has been demonstrated using commercially available products containing a large number of trace elements and vitamins (e.g., Tracutil, Cernevit) up to the standard dose recommended by the respective manufacturer of the trace element product.

Detailed information on the above-mentioned additives and the corresponding shelf-life of such mixtures can be obtained on request from the manufacturer.
Preparation for infusion
Before infusion, the emulsion should be warmed to room temperature.
Remove the aluminum cap from the infusion port (Fig. 7) and connect the infusion set (Fig. 8). Use an infusion set without an air vent or cover the air vent if using a set with an air vent. Hang the bag on an infusion stand (Fig. 9) and perform the infusion using standard technique.

For single use only. After use, discard the packaging and any unused product.
Any unused product or waste material should be disposed of in accordance with local regulations.
Do not reconnect partially used containers.
If filters are used, they must be fat-permeable (pore size ≥ 1.2 µm).
Shelf-life after opening the outer bag and after mixing the bag contents
Chemical and physicochemical stability of the mixture of amino acids, glucose, and fat has been demonstrated before use for 7 days at 2°C to 8°C and for an additional 2 days at 25°C.
Shelf-life after adding compatible additives
From a microbiological point of view, the product should be used immediately after adding additives. If the product is not used immediately after adding additives, the user is responsible for the storage period and storage conditions before use.
After the first opening (puncture of the infusion port)
The emulsion should be used immediately after opening the container.
Omegaflex special without electrolytes should not be mixed with other medicinal products for which compatibility has not been demonstrated.
Due to the risk of pseudoagglutination of Omegaflex special without electrolytes, this medicinal product should not be administered simultaneously with blood through the same infusion set.