Leaflet: information for the user

Omegaflex special without electrolytes

Emulsion for infusion

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What isOmegaflex especial without electrolytesand what it is used for

2. What you need to know before you start usingOmegaflex especial without electrolytes

3. How to useOmegaflex especial without electrolytes

4. Possible side effects

5. Storage ofOmegaflex especial without electrolytes

6. Contents of the pack and additional information

Omegaflex especial without electrolytes contains liquids and substances called amino acids and fatty acids that are essential for the growth or recovery of the organism. It also contains calories in the form of carbohydrates and fats.

Omegaflex especial without electrolytes is administered to adults, adolescents, and children over two years old.

Omegaflex especial without electrolytes is administered when there is an inability to ingest food normally.There are many situations in which this can occur, such as, for example, in the recovery phases of surgical interventions, traumas, or burns, or when there is an inability to absorb food in the stomach and intestine.

No use Omegaflex especial without electrolytes

?if you are allergic to any of the active ingredients, egg, peanut, soy, or fish, or to any of the other components of this medication (listed in section6).

?do not administer this medication to newborns, infants, and children under two years of age.

Similarly, do not useOmegaflex special without electrolytes if you have any of the following conditions:

?potentially life-threatening blood circulation problems, such as those that may occur in cases of collapse or shock

?myocardial infarction or stroke

?severe blood clotting disorder, risk of hemorrhage (severe coagulopathy, bleeding diathesis)

?blockage of blood vessels by blood clots or fat (embolism)

?severe liver insufficiency

?altered bile flow (intrahepatic cholestasis)

?severe renal insufficiency where dialysis equipment is not available

?abnormal composition of body salts

?fluid deficiency or excess in your body

?fluid in your lungs (pulmonary edema)

?severe heart failure

?certain metabolic disorders, such as:

-excessive lipids (fats) 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 control

-metabolic disorders that may occur after surgical interventions or trauma

-unknown origin coma

-insufficient oxygen supply to tissues

-abnormally high levels of acids in the blood

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to useOmegaflex special without electrolytes.

Inform your doctor if:

?you have heart, liver, or kidney problems

?you present certain types of metabolic disorders, such as diabetes, abnormal lipid levels in the blood, and disorders in the body's composition of fluids and salts or acid-base balance.

Your doctor will closely monitor you to detect the first signs of an allergic reaction (such as fever, chills, skin rash, or shortness of breath) when you receive this medication.

Your doctor will also apply additional control and tests, such as various blood sample examinations, to ensure that your body adequately assimilates the administered foods.

This medication is an electrolyte-free solution.The healthcare staff may also take measures to ensure that your body's needs for fluids and electrolytes are met.In addition toOmegaflex special without electrolytes, you may receive additional nutrients (food)to fully meet your needs.

Children

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

Use of Omegaflex special without electrolytes with other medications

Inform your doctor, pharmacist, or nurse if you are taking, have taken recently, or may need to take any other medication.

Omegaflex special without electrolytes may interact with some medications. Inform your doctor, pharmacist, or nurse if you are taking or receiving any of the following medications:

?insulin

?heparin

?medications that prevent unwanted blood clotting, such as warfarin or other coumarin derivatives

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacistbefore using this medication.If you are pregnant, you will receive this medication only if your doctor or pharmacist considers it absolutely necessary for your recovery. There are no available data on the use ofOmegaflex specialwithout electrolytesin pregnant women.

It is not recommended to breastfeed in mothers treated with parenteral nutrition.

Driving and operating machinery

This medication is usually administered to patients who are bedridden, for example, in a hospital or clinic, which excludes the possibility of driving or operating machinery. However, the medication itself does not affect the ability to drive or operate machinery.

Omegaflex special without electrolytes contains sodium

This medication contains less than 1mmol of sodium (23mg) per multi-chamber bag; that is, it is essentially “sodium-free”.

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

Your doctor or pharmacist will decide what amount of this medication you need and for how long you will need treatment with it.

Use in children

This medication should not be administered to newborns, infants, and children under two years old.

Your doctor will decide what amount of this medication your child needs and for how long your child will require treatment with this medication.

If you use more Omegaflex special without electrolytes than you should

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

?excess fluids and electrolyte imbalances

?fluid in your lungs (pulmonary edema)

?loss of amino acids through urine and imbalances in amino acid levels

?vomiting, nausea

?chills

?high blood sugar levels

?glucose in urine

?dehydration

?blood that is much more concentrated than normal (hyperosmolality)

?altered 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)

?deposition of fat 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

?alterations in blood coagulation (such as changes in bleeding time, coagulation time, prothrombin time, etc.)

?fever

?high levels of fats in the blood

?loss of consciousness

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The following side effects may be serious. If you experience any of the following side effects, inform your doctor immediately, who will stop administering this medicine:

Rare (may affect up to 1 in 1,000 people):

?allergic reactions such as, for example, skin reactions, shortness of breath, swelling of the lips, mouth, and throat, difficulty breathing

Other side effects include:

Possible (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 of blood coagulation

?blue discoloration of the skin

?shortness of breath

?headache

?flushing

?redness of the skin (erythema)

?sweating

?chills

?sensation of cold

?high body temperature

?drowsiness

?chest, back, bone, or lumbar region pain

?decrease or increase in blood pressure

Very rare (may affect up to 1 in 10,000 people):

?abnormally high levels of sugar or fat in the blood

?high levels of acidic substances in your blood

?an excess of lipids may cause overload syndrome; for more information, consult the heading, “If you use more Omegaflex special without electrolytes than you should” in section 3. The symptoms usually disappear when the infusion is interrupted.

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

?decrease in white blood cell count (leucopenia)

?decrease in platelet count (thrombocytopenia)

?bile flow alterations (cholestasis)

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use.

Website:www.notificaRAM.es

Keep this medication out of the reach and sight of children.

Do not store above25°C.

Do not freeze.Discard the bag if it has been accidentally frozen.

Store the bag in the outer packaging to protect it from light.

Do not use this medication after the expiration date shown on the label. The expiration date is the last day of the month indicated.

Composition ofOmegaflex special without electrolytes

The active ingredients 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 injection preparations.

Appearance of the product and contents of the container

The ready-to-use productis an emulsion for infusion, i.e.,it is administered through a small tube in a vein.

Omegaflex especial without electrolytes is supplied in flexible multi-chamber bags that contain:

?625ml (250ml of amino acid solution + 125ml of fat emulsion + 250ml of glucose solution)

?1,250ml (500ml of amino acid solution + 250ml of fat emulsion + 500ml of glucose solution)

?1,875ml (750ml of amino acid solution + 375ml of fat emulsion + 750ml of glucose solution)

FigureAFigureB

FigureA: The multi-chamber bag is introduced into a protective wrapper. Between the bag and the wrapper are an oxygen absorber and an oxygen indicator; the wrapper of the oxygen absorber is made of an inert material and contains iron hydroxide.

FigureB: 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 pale yellow. The fat emulsion is white and creamy.

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

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

Container sizes: 5x625ml, 5x1,250ml, and 5x1,875ml

Only some container sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

B. Braun Melsungen AG

Carl‑Braun‑Straße 1Postal address:

34212 Melsungen, Germany34209 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) with the following names:

AustriaNuTRIflex Omega special ohne ElektrolyteB.Braun

BelgiumNutriflex Omega special EF, 56g/l AA + 144g/l G,emulsie voor infusie, émulsion pour perfusion, Emulsion zur Infusion

Czech RepublicNutriflex Omega specialbez elektrolytu

DenmarkNutriflex Omega Specialelektrolytfri

FranceLIPOFLEX OMEGA G144/N8, émulsion pour perfusión

GermanyNuTRIflex Omega special ohne Elektrolyte novo

GreeceNutriflex Omega special without electrolytes

IrelandOmeflexspecial without electrolytesemulsion for infusion

ItalyOmegaflex AA38/G120senza elettroliti

LuxembourgNuTRIflex Omega special ohne ElektrolyteB.Braun

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

NorwayNutriflex Omega Special elektrolytfri

PolandNutriflex Omega special without electrolytes

PortugalNutriflex Omega special without electrolytesemulsão para perfusão

SlovakiaNutriflex Omega specialbez elektrolytov

SpainOmegaflex especialsin electrolitos emulsión para perfusión

SwedenNutriflex Omega 56/144/40 elektrolytfri

United Kingdom (Northern Ireland)Omeflexspecial without electrolytesemulsion for infusion

Last revision date of this leaflet:01/2024

For detailed information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

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This information is intended solely for healthcare professionals:

Parenteral nutrition products must be visually inspected before use to detect damage, color changes, and instability of the emulsion.

Do not use bags that show damage. The wrapper, the main bag, and the removable seams between the chambers must be intact. Use only if the amino acid and glucose solutions are clear and colorless to pale yellow and if the fat emulsion is homogeneous and white and creamy. 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 if the emulsion changes color or shows signs of phase separation.

Before opening the wrapper, check the color of the oxygen indicator (see FigureA). 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 observance of the principles of aseptic manipulation must be complied with.

To open: open the wrapper starting from the tear-off tabs (Fig.1). Remove the bag from its protective wrapper. Discard the wrapper, the oxygen indicator, and the oxygen absorber.

Visually inspect the main bag for leaks. Bags with leaks must be discarded, as it is not possible to guarantee their sterility.

Mixing the bag and adding additives

To open and mix the chambers sequentially, roll the bag with both hands, first opening the removable seam that separates the upper chamber (glucose) from the lower chamber (amino acids) (Fig.2).

Next, continue applying pressure so that the removable seam that separates the middle chamber (lipids) from the lower chamber is opened (Fig.3).

Once all the 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 contents of the bag well (Fig.5) and visually inspect the mixture (Fig.6). The mixture is a homogeneous emulsion of oil in water, white and creamy. There should be no signs of phase separation.

Omegaflex especial without electrolytes can be mixed with the following additives up to the maximum concentration specified below or up to the maximum amount of additives after supplementation. The resulting mixtures are stable for 7days between +2°C and +8°C and for 2days more at 25°C.

- Electrolytes: stability has been demonstrated up to a total amount of 200mmol/l of sodium + potassium