Omegaflex special

Package Leaflet: Information for the User

Omegaflex special

infusion emulsion

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• 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 you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

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

Omegaflex special contains fluids and substances called amino acids, electrolytes, 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 is indicated for use in adults, adolescents, and children over two years of age.
The patient receives Omegaflex special when they cannot normally eat. This can 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

When not to use Omegaflex special

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

Omegaflex special should 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, risk of bleeding (severe coagulopathy, worsening hemorrhagic diathesis);
• blockage of blood vessels by blood clots or fat (embolism);
• severe liver failure;
• disorders of bile flow (intrahepatic cholestasis);
• severe kidney failure in the absence of renal replacement therapy;
• electrolyte imbalance;
• fluid deficit or excess of water in the body;
• fluid in the lungs (pulmonary edema);
• severe heart failure;
• certain metabolic disorders, such as:
• excessive amounts of lipids (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 that may occur after surgery or injury,
• 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, discuss it with your doctor.
Tell your doctor if:

• the patient has heart, liver, or kidney problems;
• the patient has certain metabolic disorders, such as diabetes, abnormal blood fat levels, and fluid and electrolyte balance disorders or acid-base balance disorders.

During treatment with this medicine, the patient will be carefully 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.
Medical staff will also take measures to ensure that the patient's body has sufficient fluids and electrolytes. In addition to Omegaflex special, the patient will also receive other nutrients to fully meet their body's needs.

Children

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

Omegaflex special and other medicines

Tell your doctor about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take.
Omegaflex special may interact with some other medicines. Tell your doctor if the patient is taking or receiving any of the following medicines:

• insulin;
• heparin;
• medicines that prevent unwanted blood clotting, such as warfarin or other coumarin derivatives;
• medicines that improve urine production (diuretics);
• medicines used to treat high blood pressure or heart disease (ACE inhibitors and angiotensin II receptor antagonists);
• medicines used in organ transplants, such as cyclosporine and tacrolimus;
• medicines used to treat inflammatory conditions (corticosteroids);
• hormonal preparations that affect fluid balance (adrenocorticotropic hormone [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 before using this medicine. If the patient is pregnant, they will only receive this medicine if the doctor decides that it is absolutely necessary for their recovery.
There is no data on the use of Omegaflex special 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, 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.

Omegaflex special contains sodium

The medicine contains 1244 mg/ml of sodium (the main component of common salt). This corresponds to 0.062% of the maximum recommended daily intake of sodium in the diet for adults.
The maximum recommended daily dose of this medicinal product contains 3048 mg of sodium (contained in common salt). This corresponds to 152% 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 contact their doctor or pharmacist.

3. How to use Omegaflex special

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.

Overdose of Omegaflex special

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

• fluid excess and electrolyte disturbances;
• fluid in the lungs (pulmonary edema);
• loss of amino acids in the urine and amino acid imbalance;
• nausea, vomiting;
• chills;
• high blood sugar levels;
• glucose in the urine;
• fluid deficit;
• significantly higher levels of blood components than normal (hyperosmolality);
• disorders 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 red 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;
• high levels of fats 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, Omegaflex special 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 this 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, difficulty breathing.

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 cold,
• high body temperature,
• drowsiness,
• chest pain, back pain, bone pain, or pain in the 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 amounts of fat can lead to a fat overload syndrome. More information is provided under "Overdose of Omegaflex special" in section 3. 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 those 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, 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

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

6. Contents of the pack and other information

What Omegaflex special contains

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

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

What Omegaflex special looks like and contents of the pack

The ready-to-use product is an infusion emulsion, i.e., an emulsion administered through a thin tube into a vein.
Omegaflex special 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 multi-chamber 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 and amino acid solutions are clear, 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 sizes of packaging are supplied in cardboard boxes containing five bags. Packaging sizes: 5 x 625 ml, 5 x 1250 ml, and 5 x 1875 ml. Not all packaging sizes may be marketed.

Marketing authorization holder

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

Phone: +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, 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 in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria
NuTRIflex Omega special B.Braun Emulsion zur Infusion
Belgium
Nutriflex Omega special 56 g/l Amino + 144g/l G, emulsie voor infusie
Bulgaria
Nutriflex Omega 56/144 emulsion for infusion
Croatia
Nutriflex Omega 56/144 specijal emulzija infuziju
Czech Republic
Nutriflex Omega special 56/144
Denmark
Nutriflex Omega Special
Estonia
Nutriflex Omega 56/144 infusiooniemulsioon
Finland
Nutriflex Omega 56/144/40 infuusioneste, emulsio
France
REANUTRIFLEX OMEGA E, émulsion pour perfusion
Germany
NuTRIflex Omega special novo Emulsion zur Infusion
Greece
Nutriflex Omega 56/144 special
Ireland
Omeflex special emulsion for infusion
Italy
Omegaflex AA56/G144 emulsione per infusione
Latvia
Nutriflex Omega 56/144 emulsija infūzijām
Lithuania
Nutriflex Omega 56/144 infuzinė emulsija
Luxembourg
NuTRIflex Omega special novo Emulsion zur Infusion
Netherlands
Nutriflex Omega special, 56 g/l Amino + 144 g/l G, emulsie voor infusie
Norway
Nutriflex Omega Special infusjonsvæske, emulsjon
Poland
Omegaflex special
Portugal
Omegaflex special emulsão para perfusão
Romania
NuTRIflex Omega Special novo, emulsie perfuzabilă
Slovakia
Nutriflex Omega special 56/144
Slovenia
Nutriflex Omega special 56/144 emulzija za infundiranje
Spain
Nutriflex Omega 56/144 special emulsión para perfusión
Sweden
Nutriflex Omega 56/144/40 infusionsvätska, emulsion
United Kingdom (Northern Ireland)
Omeflex special emulsion for infusion

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

Information intended for healthcare professionals only:
Before using parenteral nutrition products, they should be visually inspected for any signs of damage, color changes, and emulsion instability.
Do not use bags that are damaged. 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 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). 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. Use only if the oxygen indicator is yellow.
Preparing the mixed emulsion
Strictly follow aseptic procedures.
Opening: Tear the outer bag, starting from the notches (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, fold the bag with both hands, starting from the weld separating the upper chamber (glucose) and lower chamber (amino acids) (Fig. 2).

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

• 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.

Omegaflex special 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 2-8°C and for an additional 2 days at 25°C.

• Electrolytes: consider the electrolytes already present in the bag; 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 micronutrient product.

More detailed information on the above-mentioned additives and the corresponding shelf-life of such mixtures can be obtained from the manufacturer upon request.
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 the infusion stand (Fig. 9) and perform the infusion using standard technique.

• 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 the infusion stand (Fig. 9) and perform the infusion using standard technique.

For single use only. After use, discard the packaging and any unused product.
Dispose of any unused medicinal product or waste material in accordance with local requirements.
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 2-8°C and for an additional 2 days at 25°C.
Shelf-life after adding compatible substances
From a microbiological point of view, the product should be used immediately after adding the additives. If the product is not used immediately after adding the additives, the responsibility for the shelf-life and storage conditions before use lies with the user.
After the first opening (puncture of the infusion port)
The emulsion should be used immediately after opening the packaging.
Omegaflex special should not be mixed with other medicinal products for which compatibility has not been demonstrated.
Due to the risk of pseudoagglutination of Omegaflex special, it should not be administered simultaneously with blood through the same infusion set.