Omegaflex special

Package leaflet: Information for the user

Omegaflex special
infusion emulsion
Please read carefully all the information in this leaflet before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Table of contents

1. What Omegaflex special is and what it is used for
2. What you need to know 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 Omegaflex special is and what it is used for

Omegaflex special contains fluids and substances called amino acids, electrolytes and fatty acids, which are essential for body growth or recovery. It also provides calories in the form of carbohydrates and fats.
Omegaflex special is indicated for use in adults, adolescents and children over two years of age.
You receive Omegaflex special when you are unable to take food normally. This may occur in various situations, for example during recovery after surgery, trauma or burns, or when you are unable to absorb food from the stomach and intestines.

2. Important information before using Omegaflex special

When not to use Omegaflex special

• if the patient is allergic to any of the active substances, to eggs, peanuts, soy, fish, or to any of the ingredients of this medicine (listed in section 6);
• this medicine must not be given to newborns, infants, and young children under two years of age.

Omegaflex special must also not be used if the patient has any of the following conditions:

• life-threatening circulatory disorders, such as those occurring during collapse or shock;
• heart attack or stroke;
• severe blood 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 without renal replacement therapy;
• disturbances in the body's electrolyte balance;
• fluid deficiency or excess water in the body;
• fluid in the lungs (pulmonary edema);
• severe heart failure;
• certain metabolic disorders, such as:
  • excessively high levels of lipids (fats) in the blood,
  • inherited disorders of amino acid metabolism,
  • abnormally high blood sugar levels requiring administration of more than 6 units of insulin per hour,
  • metabolic disturbances that may occur after surgery or trauma,
  • 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 this with your doctor.
Inform your doctor if:

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

While receiving this medicine, the patient will be closely monitored for early signs of allergic reactions (such as fever, chills, rash, or shortness of breath).
To ensure that the patient's body is properly processing the administered nutrients, ongoing monitoring and tests will be performed, including various blood tests.
Medical personnel will also take measures to ensure adequate fluid and electrolyte supply. In addition to Omegaflex special, the patient will receive other nutrients to fully meet the 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 currently taking or has recently taken, as well as any medicines the patient plans to take.
Omegaflex special may interact with certain other medicines. Inform your doctor if the patient is taking or receiving any of the following medicines:

• insulin;
• heparin;
• medicines preventing unwanted blood clotting, such as warfarin or other coumarin derivatives;
• medicines increasing urine production (diuretics);
• medicines used to treat high blood pressure or heart conditions (ACE inhibitors and angiotensin II receptor antagonists);
• medicines used in organ transplantation, such as cyclosporine and tacrolimus;
• medicines used to treat inflammatory conditions (corticosteroids);
• hormonal preparations affecting fluid balance (adrenocorticotropic hormone [ACTH]).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine. If the patient is pregnant, she will be given this medicine only if the doctor considers it absolutely necessary for her recovery. There are no data available 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 administered to immobilized patients, for example in hospital or clinic settings, which excludes driving and operating machinery. However, the medicine itself has no effect on the ability to drive or operate machinery.

Omegaflex special contains sodium
This medicine contains 1244 mg/ml of sodium (the main component of table salt). This corresponds to 0.062% of the maximum recommended daily dietary intake of sodium for adults.
The maximum recommended daily dose of this medicinal product contains 3048 mg of sodium (contained in table salt). This corresponds to 152% of the maximum recommended daily dietary intake of sodium for adults.
If one or more bags are administered daily over a prolonged period, patients, especially those monitoring their dietary sodium intake, should consult their doctor or pharmacist.

3. How to use Omegaflex special

This medicine is administered as an intravenous infusion (drip), meaning through a thin tube directly into a vein. This medicine will be given exclusively via one of the large (central) veins. The recommended duration of infusion for a single bag of parenteral nutrition emulsion is up to 24 hours.
The doctor will decide how much of this medicine the patient needs and how long the treatment should last.

Use in children
This medicine must not be given to newborns, infants, and young children under 2 years of age.
The doctor will decide how much of this medicine the child needs and how long the treatment should last.

Administration of a higher than recommended dose of Omegaflex special
If an excessive dose of this medicine is administered, the patient may develop so-called overload syndrome, and the following symptoms may occur:

• fluid overload and electrolyte imbalances;
• fluid in the lungs (pulmonary edema);
• loss of amino acids in urine and amino acid imbalance;
• vomiting, nausea;
• chills;
• high blood sugar levels;
• glucose in urine;
• fluid deficiency;
• significantly higher blood component concentrations than normal (hyperosmolality);
• disturbances or loss of consciousness due to extremely high blood sugar levels;
• liver enlargement (hepatomegaly) with or without jaundice;
• spleen enlargement (splenomegaly);
• fat deposition in internal organs;
• abnormal liver function test results;
• reduced number of red blood cells (anemia);
• reduced number of white blood cells (leukopenia);
• reduced number of platelets (thrombocytopenia);
• increased number of immature red blood cells (reticulocytosis);
• breakdown of blood cells (hemolysis);
• bleeding or tendency to bleed;
• blood clotting disorders (which may be observed as changes in bleeding time, clotting time, prothrombin time, etc.);
• fever;
• high blood lipid levels;
• loss of consciousness.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The side effects listed below may be serious. If any of the following side effects occur,
inform the doctor immediately, who will discontinue administration of this medicine to the patient:
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:
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,
• shortness of breath,
• headache,
• hot flushes,
• skin redness (erythema),
• sweating,
• chills,
• feeling cold,
• high body temperature,
• drowsiness,
• chest, back, bone, or lower back pain,
• low or high 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 may lead to fat overload syndrome. More information is provided under the heading “Administration of a higher than recommended dose of Omegaflex special” in section 3. Symptoms usually resolve after stopping the infusion.

Not known (frequency cannot be estimated from available data):

• reduced number of white blood cells (leukopenia),
• reduced number of platelets (thrombocytopenia),
• disturbances in bile flow (cholestasis).

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration 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 responsible entity.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Omegaflex special

Keep the medicine out of the 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 stated month.
Store the bag inside the outer protective bag to protect it from light.

6. Contents of the packaging and other information

What Omegaflex special contains
The active substances in this ready-to-use mixture are:

The other ingredients are citric acid monohydrate (for pH adjustment), egg phospholipids for injection, glycerol, sodium oleate, all-rac-α-tocopherol, sodium hydroxide (for pH adjustment), and water for injection.
What Omegaflex special looks like and what the package contains
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 three-compartment flexible bags containing:

• 625 ml (250 ml amino acid solution + 125 ml lipid emulsion + 250 ml glucose solution)
• 1250 ml (500 ml amino acid solution + 250 ml lipid emulsion + 500 ml glucose solution)
• 1875 ml (750 ml amino acid solution + 375 ml lipid emulsion + 750 ml glucose solution)

Figure A Figure B
Figure A: The multi-compartment bag is packed in an outer protective bag. Between the inner and outer bags 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 compartment contains the glucose solution, the middle compartment the lipid emulsion, and the lower compartment the amino acid solution.
The glucose and amino acid solutions are clear, colourless to straw-coloured. The lipid emulsion is milky white.
The upper and middle compartments can be connected to the lower compartment by opening the internal seals.
Different package sizes are supplied in cardboard boxes containing five bags.
Package sizes: 5 x 625 ml, 5 x 1250 ml and 5 x 1875 ml
Not all package sizes may be marketed.
Marketing Authorisation Holder
B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen, Germany
Tel.: +49-5661-71-0
Fax: +49-5661-71-4567
Manufacturer
B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen, Germany
For further information about this medicinal product, please contact the representative of the Marketing Authorisation Holder in Poland:
Aesculap Chifa sp. z o.o.
ul. Tysiąclecia 14
64-300 Nowy Tomyśl
Telephone: +48 61 442 01 00
Fax: +48 61 443 75 05
E-mail: [email protected]
This medicinal product is authorised for marketing 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
___________________________________________________________________
Information intended exclusively for healthcare professionals:
Before use, parenteral nutrition products should be visually inspected for possible damage, colour changes and emulsion instability.
Do not use bags that are damaged. The outer and inner bags, as well as the seals between compartments, should be intact. The product should be used only if the amino acid and glucose solutions are clear and colourless to straw-coloured, and the lipid emulsion is uniform and milky white. Do not use if the solutions contain particulate matter.
After mixing the contents of the three compartments, do not use if the emulsion shows discoloration or signs of phase separation (oil droplets, oil layer). In case of emulsion discoloration or signs of phase separation, infusion must be immediately stopped.
Before opening the outer bag, check the colour 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
Aseptic handling procedures must be strictly followed.
Opening: Tear open the outer bag starting from the notches (Fig. 1). Remove the inner bag from the protective packaging. Discard the outer bag, oxygen indicator and oxygen absorber.

Visually inspect the inner bag for possible leaks. Discard any leaking bag, as sterility cannot be guaranteed.
Mixing the bag contents and adding additional substances
To sequentially open the compartments and mix their contents, roll the bag with both hands, starting from the seal separating the upper (glucose) and lower (amino acids) compartments (Fig. 2).

Then continue pressing to open the seal separating the middle (lipids) and lower compartments (Fig. 3).

After mixing the contents of all compartments and removing the aluminium foil (Fig. 3A), compatible additives may be added via the medication port (Fig. 4). Mix the contents thoroughly (Fig. 5) and visually inspect the mixture (Fig. 6). The mixture is a uniform milky white oil-in-water emulsion. Any signs of emulsion phase separation are unacceptable.

Omegaflex special may be mixed with the following additives up to the upper concentration limits or maximum amounts specified below after supplementation. The resulting mixtures are stable for 7 days at +2°C to +8°C plus 2 additional days at 25°C.

• Electrolytes: consider electrolytes already present in the bag; stability in the three-component mixture has been demonstrated up to a total of 200 mmol/l sodium + potassium (combined), 9.6 mmol/l magnesium and 6.4 mmol/l calcium.
• Phosphate: stability has been demonstrated up to a maximum concentration of 20 mmol/l inorganic phosphate or up to a maximum concentration of 30 mmol/l organic phosphate (not both simultaneously).
• Alanyl-glutamine up to 24 g/l.
• Trace elements and vitamins: stability has been demonstrated when using commercially available products containing multiple trace elements and vitamins (e.g. Tracutil, Cernevit) at the standard dose recommended by the respective manufacturer of the trace element product.

Detailed information on the above-mentioned additives and appropriate shelf lives of such mixtures is available on request from the manufacturer.
Preparation for infusion
Before infusion, warm the emulsion to room temperature.
Remove the aluminium cap from the infusion port (Fig. 7) and connect an infusion set (Fig. 8). Use an infusion set without an air vent or cover the air vent if using a set with one. Hang the bag on an infusion stand (Fig. 9) and administer the infusion using standard technique.

For single use only. After use, dispose of the packaging and any unused remnants of the product.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.
Partially used containers must not be reconnected.
If filters are required, they must be lipid-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 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 prior to use.
Shelf life after addition of compatible additives
From a microbiological standpoint, the product should be used immediately after addition of additives. If the product is not used immediately after addition of additives, the user is responsible for storage duration and conditions prior to use.
After first opening (puncturing the infusion port)
The emulsion should be used immediately after opening the container.
Omegaflex special must not be mixed with other medicinal products for which compatibility has not been demonstrated.
Due to the risk of pseudoagglutination, Omegaflex special must not be administered simultaneously with blood through the same infusion set.