Omegaflex Especial without electrolytes emulsion for infusion

Package leaflet: Information for the user

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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Omegaflex special without electrolytes is and what it is 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. How to store Omegaflex special without electrolytes
6. Contents of the pack and other information

1. What Omegaflex special without electrolytes is and what it is 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 provides 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 given when there is an inability to take food normally. There are many situations in which this may occur, for example, during recovery phases following surgical procedures, trauma, or burns, or when there is an inability to absorb food in the stomach and intestine.

2. What you need to know before using Omegaflex special without electrolytes

Do not use Omegaflex special without electrolytes

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

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

Also, do not use Omegaflex special without electrolytes if you have any of the following conditions:

? potentially life-threatening circulatory problems, such as those occurring in cases of collapse or shock

? myocardial infarction or stroke

? severe coagulation disorders, risk of bleeding (severe coagulopathy, aggravating hemorrhagic diatheses)

? blockage of blood vessels due to blood clots or fat (embolism)

? severe liver failure

? impaired bile flow (intrahepatic cholestasis)

? severe renal failure when dialysis equipment is not available

? disturbances in the body's electrolyte composition

? fluid deficiency or excess water in your body

? fluid in your lungs (pulmonary edema)

? severe heart failure

? certain metabolic disorders such as, for example:

• excessive lipids (fats) in the blood
• congenital amino acid metabolism disorders
• abnormally high blood sugar levels requiring more than 6 units of insulin per hour to be controlled
• metabolic disturbances that may occur after surgery or trauma
• coma of unknown origin
• inadequate oxygen supply to tissues
• abnormally high levels of acids in the blood

Warnings and precautions

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

Inform your doctor if:

? you have heart, liver, or kidney problems

? you have certain types of metabolic disorders such as diabetes, abnormal blood lipid levels, or disturbances in the body's fluid, electrolyte, or acid-base balance.

You will be closely monitored for early signs of an allergic reaction (such as fever, chills, skin rash, or shortness of breath) while receiving this medicine.

Additional monitoring and tests, such as various blood tests, will be performed to ensure your body is properly assimilating the administered nutrients.

This medicine is an electrolyte-free solution. Healthcare professionals may also take measures to ensure 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 requirements.

Children

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

Use of Omegaflex special without electrolytes with other medicines

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

Omegaflex special without electrolytes may interact with certain medicines. Inform 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 plan to become pregnant, consult your doctor or pharmacist 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 receiving parenteral nutrition.

Driving and use of machines

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

Omegaflex special without electrolytes contains sodium

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

3. How to use Omegaflex special without electrolytes

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

Your doctor or pharmacist will decide how much of this medicine you need and how long you will require treatment with it.

Use in children

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

Your doctor will decide how much of this medicine your child needs and how long your child will require treatment 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 experience the so-called "overload syndrome" and the following symptoms:

• Excess fluid and electrolyte disturbances
• Fluid in your lungs (pulmonary edema)
• Loss of amino acids through urine and imbalances in amino acid levels
• Vomiting, nausea
• Tremors
• High blood sugar level
• Glucose in urine
• Fluid deficiency
• Blood much more concentrated than normal (hyperosmolality)
• Impaired or loss of consciousness due to extremely high blood sugar levels
• Enlargement of the liver (hepatomegaly) with or without jaundice
• Enlargement of the spleen (splenomegalia)
• 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)
• Increase in immature red blood cells (reticulocytosis)
• Breakdown of blood cells (hemolysis)
• Bleeding or tendency to bleed
• Blood coagulation disorders (as evidenced by 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 must be stopped immediately.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.

The following adverse effects can be serious. If you experience any of the following adverse 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, dyspnea, swelling of the lips, mouth and throat, difficulty breathing

Other adverse 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

• Bluish discoloration of the skin

• Dyspnea

• Headache

• Flushing

• Skin redness (erythema)

• Sweating

• Chills

• Feeling cold

• High body temperature

• Drowsiness

• Chest, back, bone or lower back 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

• Elevated levels of acidic substances in the blood

• Excess lipids may cause overload syndrome; for further information, see section 3, “If you use more Omegaflex special without electrolytes than you should”

Symptoms usually disappear when the infusion is stopped.

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

• Decrease in white blood cell count (leukopenia)

• Decrease in platelet count (thrombocytopenia)

• Biliary flow disorders (cholestasis)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, including possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines.

Website: www.notificaRAM.es

5. Special storage instructions for Omegaflex 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 stated on the label. The expiry date is the last day of the month indicated.

6. Contents of the package and other information

Composition of Omegaflex special without electrolytes

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

From the upper chamber (glucose solution)	in 1,000ml	in 625ml	in 1,250ml	in 1,875ml
Glucose monohydrate	158.4 g	99.00 g	198.0 g	297.0 g
equivalent to glucose	144.0 g	90.00 g	180.0 g	270.0 g

From the middle chamber (fat emulsion)	in 1,000ml	in 625ml	in 1,250ml	in 1,875ml
Medium-chain triglycerides	20.00 g	12.50 g	25.00 g	37.50 g
Refined soybean oil	16.00 g	10.00 g	20.00 g	30.00 g
Omega-3 fatty acid triglycerides	4.000 g	2.500 g	5.000 g	7.500 g

From the lower chamber (amino acid solution)	in 1,000ml	in 625ml	in 1,250ml	in 1,875ml
Isoleucine	3.284 g	2.053 g	4.105 g	6.158 g
Leucine	4.384 g	2.740 g	5.480 g	8.220 g
Lysine monohydrate	3.576 g	2.235 g	4.470 g	6.705 g
equivalent to lysine	3.184 g	1.990 g	3.979 g	5.969 g
Methionine	2.736 g	1.710 g	3.420 g	5.130 g
Phenylalanine	4.916 g	3.073 g	6.145 g	9.218 g
Threonine	2.540 g	1.588 g	3.175 g	4.763 g
Tryptophan	0.800 g	0.500 g	1.000 g	1.500 g
Valine	3.604 g	2.253 g	4.505 g	6.758 g
Arginine	3.780 g	2.363 g	4.725 g	7.088 g
Histidine	1.752 g	1.095 g	2.190 g	3.285 g
Alanine	6.792 g	4.245 g	8.490 g	12.73 g
Aspartic acid	2.100 g	1.313 g	2.625 g	3.938 g
Glutamic acid	4.908 g	3.068 g	6.135 g	9.203 g
Glycine	2.312 g	1.445 g	2.890 g	4.335 g
Proline	4.760 g	2.975 g	5.950 g	8.925 g
Serine	4.200 g	2.625 g	5.250 g	7.875 g

	in 1,000ml	in 625ml	in 1,250ml	in 1,875ml
Content of amino acids [g]	56.0	35.0	70.1	105.1
Content of nitrogen [g]	8	5	10	15
Content of carbohydrates [g]	144	90	180	270
Content of lipids [g]	40	25	50	75

	in 1,000ml	in 625ml	in 1,250ml	in 1,875ml
Energy as lipids [kJ (kcal)]	1,590 (380)	995 (240)	1,990 (475)	2,985 (715)
Energy as carbohydrates [kJ (kcal)]	2,415 (575)	1,510 (360)	3,015 (720)	4,520 (1,080)
Energy as amino acids [kJ (kcal)]	940 (225)	585 (140)	1,170 (280)	1,755 (420)
Non-protein energy [kJ (kcal)]	4,005 (955)	2,505 (600)	5,005 (1,195)	7,510 (1,795)
Total energy [kJ (kcal)]	4,945 (1,180)	3,090 (740)	6,175 (1,475)	9,265 (2,215)

Osmolality [mOsm/kg]	1,840
Theoretical osmolarity [mOsm/L]	1,330
pH	5.0 – 6.0

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 injections.

Appearance of the product and contents of the pack

The ready-to-use product is an emulsion for infusion, meaning it is administered through a small tube into a vein.

Omegaflex special without electrolytes is supplied in flexible multi-chamber bags containing:

? 625 ml (250 ml amino acid solution + 125 ml lipid emulsion + 250 ml glucose solution)
? 1,250 ml (500 ml amino acid solution + 250 ml lipid emulsion + 500 ml glucose solution)
? 1,875 ml (750 ml amino acid solution + 375 ml lipid emulsion + 750 ml glucose solution)

Figure A Figure B

Figure A: The multi-chamber bag is enclosed in a protective overwrap. Between the bag and the overwrap are 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 a glucose solution, the middle chamber contains a lipid emulsion, and the lower chamber contains an amino acid solution.

The glucose and amino acid solutions are clear and colorless to pale yellow. The lipid emulsion is milky white in appearance.

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

Different pack sizes are available in cartons containing five bags.

Pack sizes: 5 × 625 ml, 5 × 1,250 ml, and 5 × 1,875 ml

Only certain pack 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 European Economic Area (EEA) Member States and 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 latest revision of this leaflet: 01/2024

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

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This information is intended for healthcare professionals only:

Parenteral nutrition products should be visually inspected before use for damage, color changes, and emulsion instability.

Do not use bags showing damage. The overwrap, main bag, and peelable seals between chambers must be intact. Use only if the amino acid and glucose solutions are clear and colorless to pale yellow, and if the lipid emulsion is homogeneous and milky white. Do not use if solutions contain particles.

After mixing all three chambers, do not use if the emulsion shows color change or signs of phase separation (oil droplets, oil layer). Immediately stop the infusion if color change or phase separation occurs.

Before opening the overwrap, check the color of the oxygen indicator (see Figure A). Do not use if the oxygen indicator has turned pink. Use only if the oxygen indicator is yellow.

Preparation of the mixed emulsion

Strict adherence to aseptic handling principles must be observed.

For opening: tear the overwrap starting at the notches (Fig. 1). Remove the bag from its protective overwrap. Discard the overwrap, oxygen indicator, and oxygen absorber.

Visually inspect the main bag for leaks. Bags with leaks must be discarded, as sterility cannot be guaranteed.

Mixing the chambers and addition of additives

To open and mix the chambers sequentially, roll the bag with both hands, first opening the peelable seal between the upper chamber (glucose) and the lower chamber (amino acids) (Fig. 2).

Then continue applying pressure to open the peelable seal between the middle chamber (lipids) and the lower chamber (Fig. 3).

Once all chambers are mixed and after removing the aluminum seal (Fig. 3A), compatible additives may be added via the medication port (Fig. 4). Mix the bag contents thoroughly (Fig. 5) and visually inspect the mixture (Fig. 6). The mixture is a homogeneous oil-in-water emulsion, milky white in color. There must be no signs of emulsion phase separation.

Omegaflex special without electrolytes may be mixed with the following additives up to the specified maximum concentration limits or maximum additive amounts after supplementation. The resulting mixtures are stable for 7 days at +2°C to +8°C and for an additional 2 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 simultaneously).
• Alanyl-glutamine, up to 24 g/l.
• Trace elements and vitamins: stability has been demonstrated with commercial multitrace element and multivitamin preparations (e.g., Tracutil, Cernevit) up to the standard dosage recommended by the micronutrient manufacturer.

The manufacturer can provide, upon request, detailed information on the above-mentioned additives and the corresponding shelf life of such mixtures.

Preparation for infusion

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

Remove the aluminum film from the infusion port (Fig. 7) and connect the infusion set (Fig. 8). Use an infusion set without an air vent, or close the air vent if using a vented set. Hang the bag on an infusion hook (Fig. 9) and administer according to standard technique.

For single use only. The container and unused waste must be disposed of after use.

Disposal of unused medicine and all materials that have been in contact with it must comply with local regulations.

Do not reconnect partially used containers.

If filters are used, they must be lipid-permeable (pore size ≥ 1.2 µm).

Shelf life after removal of the protective overwrap and after mixing the bag contents

Chemical and physicochemical stability during use of the amino acid, glucose, and lipid mixture has been demonstrated for 7 days at 2–8°C and for an additional 2 days at 25°C.

Shelf life after additional mixing of compatible additives

From a microbiological standpoint, the product should be used immediately after additional mixing of additives. Otherwise, the storage times and conditions prior to use are the responsibility of the user.

After first opening (puncture 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 through the same infusion set due to the risk of pseudoagglutination.