Omegaflex plus emulsion for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Omegaflex Plus emulsion for infusion

Read the entire 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 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 adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Omegaflex Plus is and what it is used for
2. What you need to know before using Omegaflex Plus
3. How to use Omegaflex Plus
4. Possible adverse effects
5. How to store Omegaflex Plus
6. Contents of the pack and other information

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

Omegaflex plus contains liquids and substances called amino acids, electrolytes, 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 plus is administered to adults, adolescents, and children over two years of age.

Omegaflex plus is given when there is an inability to take food normally. There are many situations in which this may occur, such as 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 plus

Do not use Omegaflex plus

• if you are allergic to any of the active substances, to egg, peanut, soy, fish, or to 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 plus if you have any of the following conditions:

• potentially life-threatening circulatory disorders, such as those that may occur in cases of collapse or shock

• myocardial infarction or stroke

• severe coagulation disorders, risk of bleeding (severe coagulopathy, worsening hemorrhagic diathesis)

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

• severe hepatic insufficiency

• impaired bile flow (intrahepatic cholestasis)

• severe renal insufficiency when dialysis equipment is not available

• disturbances in the body's electrolyte composition

• fluid deficit or excess water in your body

• fluid in your lungs (pulmonary edema)

• severe cardiac insufficiency

• 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 surgical procedures or trauma
• coma of unknown origin
• inadequate oxygen supply to tissues
• abnormally high levels of acid in the blood

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Omegaflex plus.

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 and electrolyte composition 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.

You will receive additional monitoring and tests, such as various blood sample examinations, to ensure your body is properly assimilating the administered nutrients.

Healthcare professionals may also take measures to ensure your body's fluid and electrolyte needs are met. In addition to Omegaflex plus, 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 plus with other medicines

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

Omegaflex plus 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

• medicines that promote urine flow (diuretics)

• medicines for treating high blood pressure or heart problems (ACE inhibitors and angiotensin II receptor antagonists)

• medicines used in organ transplantation, such as cyclosporine and tacrolimus

• medicines for treating inflammation (corticosteroids)

• hormonal preparations affecting your fluid balance (adrenocorticotropic hormone [ACTH])

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 available data on the use of Omegaflex plus 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 setting, 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 plus contains sodium

This medicine contains 0.931 mg of sodium (the main component of table/cooking salt) per ml. This corresponds to 0.047% of the maximum daily sodium intake recommended for an adult.

The maximum recommended daily dose of this medicine contains 2607 mg of sodium (present in table salt). This corresponds to 130% of the maximum daily sodium intake recommended for an adult.

Consult your doctor or pharmacist if you need one or more bags per day for a prolonged period, especially if you have been advised to follow a low-salt (sodium) diet.

3. How to use Omegaflex plus

This medicine is administered by intravenous infusion (drop by drop), i.e., 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 for how long your child will require treatment with it.

If you use more Omegaflex plus than you should

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

• fluid overload and electrolyte disturbances
• fluid in your lungs (pulmonary edema)
• loss of amino acids through urine and disturbances in amino acid balance
• vomiting, nausea
• chills
• high blood sugar levels
• glucose in urine
• fluid deficit
• blood much more concentrated than normal (hyperosmolality)
• altered or loss of consciousness due to extremely high blood sugar levels
• enlargement of the liver (hepatomegalia), with or without jaundice
• enlargement of the spleen (splenomegaly)
• fat deposition in internal organs
• abnormal liver function test results
• reduced red blood cell count (anemia)
• reduced white blood cell count (leukopenia)
• reduced platelet count (thrombocytopenia)
• increase in immature red blood cells (reticulocytosis)
• breakdown of blood cells (hemolysis)
• bleeding or tendency to bleed
• disturbances in blood coagulation (as seen 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 everyone will experience them.

The following adverse effects may be serious. If you experience any of the following, inform your doctor immediately, who will discontinue administration of this medicine:

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

• allergic reactions such as 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

• redness of the skin (erythema)

• sweating

• chills

• feeling of cold

• high body temperature

• drowsiness

• chest, back, bone or lumbar 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 plus than you should”

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

• decrease in white blood cell count (leukopenia)

• decrease in platelet count (thrombocytopenia)

• disturbances in bile flow (cholestasis)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet.

You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products. Website: www.notificaRAM.es

5. Storage of Omegaflex plus

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.

Do not use this medicine after the expiry date stated on the label. The expiry date is the last day of the month indicated.

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

6. Contents of the container and additional information

Composition of Omegaflex plus

The active substances in 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 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 plus is supplied in flexible multi-chamber bags containing:

? 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)
? 2,500 ml (1,000 ml amino acid solution + 500 ml lipid emulsion + 1,000 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 x 1,250 ml, 5 x 1,875 ml, and 5 x 2,500 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

Further information on this medicinal product may be requested from the local representative of the Marketing Authorization Holder.

• Braun Medical, S.A.
  Ctra. de Terrasa, 121
  08191 Rubí, Spain

This medicinal product is authorized in the European Economic Area Member States and in the United Kingdom (Northern Ireland) under the following names:

Austria NuTRIflex Omega plus B.Braun
Belgium Nutriflex Omega plus 38 g/l AA 120 g/l G, émulsion pour perfusion / emulsie voor infusie / Emulsion zur Infusion
Bulgaria Nutriflex Omega 38/120 emulsion for infusion
Croatia Nutriflex Omega 38/120 plus emulzija infuziju
Czech Republic Nutriflex Omega plus 38/120
Denmark Nutriflex Omega Plus
Finland Nutriflex Omega 38/120/40
France LIPOFLEX OMEGA G120/N5,4/E, émulsion pour perfusion
Germany NuTRIflex Omega plus novo
Greece Nutriflex Omega 38/120 plus
Ireland Omeflex plus emulsion for infusion
Italy Omegaflex AA38/G120 emulsione per infusione
Luxembourg NuTRIflex Omega plus B.Braun
Netherlands Nutriflex Omega plus, 38 g/l + 120 g/l, emulsie voor infusie
Norway Nutriflex Omega Plus
Poland Omegaflex plus
Portugal Omegaflex plus emulsão para perfusão
Romania Omegaflex plus emulsie perfuzabila
Slovakia Nutriflex Omega plus 38/120
Spain Omegaflex plus emulsión para perfusión
Sweden Nutriflex Omega 38/120/40
United Kingdom (Northern Ireland) Omeflex plus 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/)

_____________________________________________________________________________

This information is intended for healthcare professionals only:

Parenteral nutrition products should be visually inspected before use for signs of 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 the 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: open the overwrap starting at the tear 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 bag and addition of additives

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

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

Once all chambers have been 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 phase separation.

Omegaflex plus 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: electrolytes already present in the bag must be taken into account; 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.
• Alanyl-glutamine, up to 24 g/l.
• Trace elements and vitamins: stability has been demonstrated with commercial multi-trace 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 strip from the infusion port (Fig. 7) and connect the infusion set (Fig. 8). Use an infusion set without a 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 discarded after use.

Disposal of unused medication and all materials that have been in contact with it must 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).

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

Chemical and physicochemical stability 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 mixing with additives. Otherwise, the storage times and conditions prior to use are the responsibility of the user.

After first opening (perforation of the infusion port)

The emulsion must be used immediately after opening the container.

Omegaflex plus must not be mixed with other medicinal products whose compatibility has not been documented.

Omegaflex plus must not be administered simultaneously with blood through the same infusion set due to the risk of pseudoagglutination.