OMEGAFLEX ESPECIAL WITHOUT ELECTROLYTES EMULSION FOR PERFUSION

Introduction

Package Leaflet: Information for the User

Omegaflex Special Without Electrolytes

Emulsion for Infusion

Read all of this leaflet carefully before you start 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 you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Omegaflex Special Without Electrolytes and what is it used for
2. What you need to know before you use Omegaflex Special Without Electrolytes
3. How to use Omegaflex Special Without Electrolytes
4. Possible side effects
5. Storage of Omegaflex Special Without Electrolytes
6. Contents of the pack and further 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 that are essential for growth or recovery of the body. It also contains calories in the form of carbohydrates and fats.

Omegaflex Special Without Electrolytes is administered to adults, adolescents, and children over two years of age.

Omegaflex Special Without Electrolytes is administered when there is an inability to ingest food normally. There are many situations where this can occur, such as during the recovery phases of surgical interventions, trauma, or burns, or when there is an inability to absorb food in the stomach and intestine.

2. What you need to know before you use Omegaflex Special Without Electrolytes

Do not use Omegaflex Special Without Electrolytes

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

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

Also, do not use Omegaflex Special Without Electrolytes 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 body's salt composition

fluid deficit or excess water in your body

water in your lungs (pulmonary edema)

severe heart failure

certain metabolic disorders, such as:

• too much fat (lipids) 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 the tissues
• abnormally high acid levels in the blood

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to use Omegaflex Special Without Electrolytes.

Tell 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 medicine.

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

This medicine 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 Omegaflex Special Without Electrolytes, you may receive additional nutrients (food) to fully meet your needs.

Children

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

Using Omegaflex Special Without Electrolytes with other medicines

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

Omegaflex Special Without Electrolytes may interact with some medicines. Tell your doctor, pharmacist, or nurse if you 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 you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. If you are pregnant, you will receive this medicine only if your doctor or pharmacist considers it absolutely necessary for your recovery. There are no data available on the use of Omegaflex Special Without Electrolytes in pregnant women.

Breastfeeding is not recommended in mothers treated with parenteral nutrition.

Driving and Using Machines

This medicine 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, the medicine itself has no effects on the ability to drive or use machines.

Omegaflex Special Without Electrolytes contains sodium

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

3. How to use Omegaflex Special Without Electrolytes

This medicine is administered by intravenous infusion (drop by drop), i.e., through a small tube into a vein. This medicine will only be administered through one of your large veins (central veins). The recommended duration for the infusion of a parenteral nutrition bag is a maximum of 24 hours.

Your doctor or pharmacist will decide what dose of this medicine you need and for how long you need to be treated with it.

Use in Children

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

Your doctor will decide what dose of this medicine your child needs and for how long your child needs to be treated with this medicine.

If you use more Omegaflex Special Without Electrolytes than you should

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

excess fluid and electrolyte disturbances

water in your lungs (pulmonary edema)

loss of amino acids through the urine and disturbances in amino acid balance

vomiting, nausea

chills

high blood sugar levels

glucose in urine

fluid deficit

blood that is much more concentrated than normal (hyperosmolality)

altered or lost consciousness due to extremely high blood sugar levels

enlargement of the liver (hepatomegaly) with or without jaundice

enlargement of the spleen (splenomegaly)

fat deposits in internal organs

abnormal values in liver function tests

reduction in red blood cell count (anemia)

reduction in white blood cell count (leukopenia)

reduction in platelet count (thrombocytopenia)

increase in immature red blood cells (reticulocytosis)

breakdown of blood cells (hemolysis)

bleeding or tendency to bleed

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

fever

high levels of fat in the blood

loss of consciousness

If any of the following symptoms occur, the infusion must be stopped immediately.

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

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, tell your doctor immediately, who will stop administering this medicine to you:

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 for blood to clot

blue discoloration of the skin

shortness of breath

headache

flushing

redness of the skin (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 sugar or fat levels in the blood

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 Omegaflex Special Without Electrolytes than you should" in section 3. The symptoms usually disappear when the infusion is stopped.

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

reduction in white blood cell count (leukopenia)

reduction in platelet count (thrombocytopenia)

disorders of bile flow (cholestasis)

Reporting of Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use.

Website: www.notificaRAM.es

5. Storage of Omegaflex Special Without Electrolytes

Keep this medicine 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 medicine after the expiry date which is stated on the label. The expiry date is the last day of the month stated.

6. Container Content and Additional Information

Composition ofOmegaflex 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, sodium hydroxide (for pH adjustment), 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.

Omegaflex 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's envelope 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 light yellow. The fat emulsion is white and milky.

The upper and middle chambers can be connected to the lower one by opening the intermediate seams.

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

Container sizes: 5 x 625 ml, 5 x 1,250 ml, and 5 x 1,875 ml

Only some container sizes may be marketed.

Marketing Authorization Holder and Manufacturer

• Braun Melsungen AG

Carl-Braun-Straße 1 Postal Address:

34212 Melsungen, Germany 34209 Melsungen, Germany

Phone: +49-5661-71-0

Fax: +49-5661-71-4567

This medicinal product is authorized 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 EF, 56 g/l AA + 144 g/l G, emulsie voor infusie, émulsion pour perfusion, Emulsion zur Infusion

Czech Republic Nutriflex Omega special bez elektrolytu

Denmark Nutriflex Omega Special elektrolytfri

France LIPOFLEX OMEGA G144/N8, émulsion pour perfusion

Germany NuTRIflex Omega special ohne Elektrolyte novo

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 B.Braun

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

Norway Nutriflex Omega Special elektrolytfri

Poland Nutriflex Omega special without electrolytes

Portugal Nutriflex Omega special without electrolytes emulsão para perfusão

Slovakia Nutriflex Omega special bez elektrolytov

Spain Omegaflex especial sin electrolitos emulsión para perfusión

Sweden Nutriflex Omega 56/144/40 elektrolytfri

United Kingdom (Northern Ireland) Omeflex special without electrolytes emulsion for infusion

Date of Last Revision of this Leaflet:01/2024

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/)

__________________________________________________________________________

This information is intended only for healthcare professionals:

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 tear-off seams between the chambers must be intact. Use only if the amino acid and glucose solutions are clear and colorless to light yellow and if the lipid emulsion is homogeneous and white. 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 of 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 aseptic handling principles 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 tear-off seam that separates the upper chamber (glucose) from the lower chamber (amino acids) (Fig. 2).

Then, continue applying pressure so that the tear-off seam that separates the middle chamber (lipids) from the lower chamber opens (Fig. 3).

Once all chambers have been mixed and after removing the aluminum seal (Fig. 3A), it is possible to add compatible additives through the medication port (Fig. 4). Mix the bag contents well (Fig. 5) and visually inspect the mixture (Fig. 6). The mixture is a homogeneous oil-in-water emulsion with a white, milky color. There should be no signs of phase separation.

Omegaflex Special Without Electrolytes can be mixed with the following additives up to the specified maximum concentration limits or up to the maximum amount of additives after supplementation. The resulting mixtures are stable for 7 days between +2 °C and +8 °C and for 2 additional days at 25 °C.

• Electrolytes: stability has been demonstrated up to a total of 200 mmol/l of sodium + potassium (sum), 9.6 mmol/l of magnesium, and 6.4 mmol/l of calcium in the ternary mixture.

• Phosphate: stability has been demonstrated up to a maximum concentration of 20 mmol/l for inorganic phosphate or up to a maximum concentration of 30 mmol/l for organic phosphate (not both at the same time).

• Alanine-glutamine, up to 24 g/l.

• Oligoelements and vitamins: stability has been demonstrated with commercial multi-oligoelements and multivitamins (e.g., Tracutil, Cernevit) up to the standard recommended dosage by the manufacturer of the micronutrients.

The manufacturer may provide, upon request, detailed information on the aforementioned additives and the corresponding validity period of such mixtures.

Preparation for Infusion

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

Remove the aluminum foil from the infusion port (Fig. 7) and connect the infusion equipment (Fig. 8). 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. 9) and perform the infusion according to standard technique.

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

The disposal of unused medicinal products and all materials that have come into contact with them will be carried out in accordance with local regulations.

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 has been demonstrated during the use of the amino acid, glucose, and lipid mixture 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 during use and the conditions prior to use are the responsibility of the user.

After the First Opening (Perforation of the Infusion Port)

The emulsion must be used immediately after opening the container.

Omegaflex Special Without Electrolytes must not be mixed with other medicinal products whose compatibility has not been documented.

Omegaflex Special Without Electrolytes must not be administered simultaneously with blood in the same infusion equipment due to the risk of pseudoagglutination.