Omegaflex special without electrolytes

Patient Information Leaflet

Omegaflex special bez elektrolitów
Intravenous emulsion
Please read all of this leaflet carefully before this medicine is administered, as it contains
important information for you.

• 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.

Contents of the leaflet

1. What Omegaflex special bez elektrolitów is and what it is used for
2. Important information before administration of Omegaflex special bez elektrolitów
3. How to use Omegaflex special bez elektrolitów
4. Possible side effects
5. How to store Omegaflex special bez elektrolitów
6. Contents of the pack and other information

1. What Omegaflex special bez elektrolitów is and what it is used for

Omegaflex special bez elektrolitów contains fluids and substances called amino acids and fatty
acids, which are essential for body growth or recovery. It also provides calories in the form of
carbohydrates and fats.
Omegaflex special bez elektrolitów is indicated for use in adults, adolescents and children over
the age of two years.
You are given Omegaflex special bez elektrolitów when you are unable to take food normally. This
may occur in many 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 administration of Omegaflex special bez elektrolitów

When not to use Omegaflex special bez elektrolitów

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

Omegaflex special bez elektrolitów must also not be used if you have any of the following conditions:

• life-threatening circulatory disorders, such as those occurring in shock or collapse;
• heart attack or stroke;
• severe blood coagulation disorders, risk of bleeding (severe coagulopathy, worsening haemorrhagic diathesis);
• blockage of blood vessels by blood clots or fat (thrombosis, 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 oedema);
• severe heart failure;
• certain metabolic disorders, such as:
  • excess lipids (fats) in the blood,
  • inherited disorders of amino acid metabolism,
  • abnormally high blood sugar levels requiring 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 bez elektrolitów, discuss with your doctor.
Tell your doctor if:

• you have heart, liver or kidney disorders;
• you have certain metabolic disorders, such as diabetes, abnormal blood lipid levels, or disturbances in fluid and electrolyte balance or acid-base balance.

While receiving this medicine, you will be closely monitored for early signs of allergic reactions (such as fever, chills, rash or shortness of breath).
To ensure your body is properly processing the nutrients provided, further monitoring and tests will be performed, including various blood tests.
This medicine is an electrolyte-free solution. Healthcare professionals will also take measures to ensure your body's needs for fluids and electrolytes are met.
In addition to Omegaflex special bez elektrolitów, you may also receive other nutritional substances to fully meet your requirements.

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

Omegaflex special bez elektrolitów and other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Omegaflex special bez elektrolitów may interact with certain other medicines.
Tell your doctor if you are taking or receiving any of the following medicines:

• insulin;
• heparin;
• anticoagulant medicines 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 become pregnant, consult your doctor before using this medicine. You will receive this medicine during pregnancy only if your doctor considers it absolutely necessary for your treatment. There are no data on the use of Omegaflex special bez elektrolitów in pregnant women.
Breastfeeding is not recommended in mothers receiving parenteral nutrition.

Driving and using machines
This medicine is usually administered to bedridden patients in hospital or clinic settings, which excludes driving and operating machinery. However, this medicine itself has no effect on the ability to drive or operate machinery.

Omegaflex special bez elektrolitów contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per multi-chamber bag, meaning it is considered "sodium-free".

3. How to use Omegaflex special without electrolytes

This medicine is administered as an intravenous infusion (drip), meaning through a thin tube directly into a vein. This medicine will be given exclusively through 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 with this medicine will 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 with this medicine will last.
Administration of a higher than recommended dose of Omegaflex special without electrolytes
If too high a dose of this medicine is administered, the patient may develop a so-called overload syndrome, and the following symptoms may occur:

• fluid overload and electrolyte disturbances;
• fluid in the lungs (pulmonary edema);
• loss of amino acids in urine and amino acid imbalance;
• vomiting, nausea;
• chills;
• increased blood glucose concentration;
• glucose in urine;
• fluid deficiency;
• significantly higher concentration of blood components than normal (hyperosmolality);
• disturbances or loss of consciousness due to extremely high blood glucose concentration;
• enlargement of the liver (hepatomegalia) with or without jaundice;
• enlargement of the spleen (splenomegalia);
• 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 bleeding;
• coagulation disorders (which may be observed as changes in bleeding time, clotting time, prothrombin time, etc.);
• fever;
• increased blood lipid levels;
• loss of consciousness.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The adverse reactions listed below may be severe. If any of the following adverse reactions occur,
inform the doctor immediately, who will decide whether to discontinue administration of the medicine to the patient:
Rare (may occur in up to 1 in 1,000 people):

• allergic reactions, such as skin reactions, shortness of breath, swelling of the lips, mouth and throat, breathing difficulties.

Other adverse reactions:
Uncommon (may occur in up to 1 in 100 people):

• nausea, vomiting, loss of appetite

Rare (may occur in 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 of cold,
• high body temperature,
• drowsiness,
• chest, back, bone or lower back pain,
• low or high blood pressure.

Very rare (may occur in 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 fat levels may lead to fat overload syndrome. More information on this is provided in section 3 "Use of a higher than recommended dose of Omegaflex special bez elektrolitów". Symptoms usually resolve after stopping the infusion.

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

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

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Omegaflex special bez elektrolitów

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not freeze. If accidental freezing occurs, discard the bag.
Store the bag in the outer protective bag to protect from light.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the stated month.

6. Contents of the package and other information

What Omegaflex special bez elektrolitów contains
The active substances in the ready-to-use mixture are:

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 bez elektrolitów looks like and contents of the pack
The ready-to-use product is an infusion emulsion, i.e. an emulsion administered through a thin tube into
a vein.
Omegaflex special bez elektrolitów is supplied in flexible, three-compartment bags containing:

• 625 ml (250 ml amino acid solution + 125 ml fat emulsion + 250 ml glucose solution)
• 1250 ml (500 ml amino acid solution + 250 ml fat emulsion + 500 ml glucose solution)
• 1875 ml (750 ml amino acid solution + 375 ml fat 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 bag there 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 glucose solution, the middle compartment contains fat emulsion, and the lower compartment contains amino acid solution.
The glucose solution and amino acid solution are clear and colourless to straw-coloured.
The fat emulsion is milky white.
The upper and middle compartments can be connected to the lower compartment by opening internal seals.
Different pack sizes are supplied in cardboard boxes containing five bags.
Pack sizes: 5 x 625 ml, 5 x 1250 ml, and 5 x 1875 ml
Not all pack 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, contact the local 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 in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Austria NuTRIflex Omega special ohne Elektrolyte B.Braun
Belgium Nutriflex Omega special zonder elektrolyten 56 g/l Amino + 144 g/l G,
emulsie voor infusie
Czech Republic Nutriflex Omega special bez elektrolytů
Denmark Nutriflex Omega Special elektrolytfri
France REANUTRIFLEX OMEGA, émulsion pour perfusion
Germany NuTRIflex Omega special ohne Elektrolyte novo Emulsion zur Infusion
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 novo Emulsion zur Infusion
Netherlands Nutriflex Omega special zonder elektrolyten, 56 g/l Amino + 144 g/l G,
emulsie voor infusie
Norway Nutriflex Omega Special elektrolytfri infusjonsvæske, emulsjon
Poland Omegaflex special bez elektrolitów
Portugal Nutriflex Omega S sem eletrólitos emulsão para perfusão
Slovakia Nutriflex Omega special bez elektrolytov
Spain Nutriflex Omega special sin electrolitos Emulsión para perfusión
Sweden Nutriflex Omega 56/144/40 elektrolytfri infusionsvätska, emulsion
United Kingdom (Northern Ireland) Omeflex special without electrolytes emulsion for infusion

Information intended exclusively for healthcare professionals:

Before using parenteral nutrition products, visually inspect for any damage, discoloration, or emulsion instability.
Do not use bags that are damaged. The outer and inner bags, as well as the seals between compartments, must be intact. The product should be used only if amino acid and glucose solutions are clear and colorless to straw-colored, and the fat emulsion is a uniform milky white. Do not use if particulate matter is present.
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). If discoloration or phase separation occurs, infusion must be immediately discontinued.
Before opening the outer bag, check the color of the oxygen indicator (see Figure A). Do not use if the oxygen indicator has changed to pink. Use only if the oxygen indicator is yellow.

Preparation of the mixed emulsion
Strict aseptic handling procedures must be followed.
Opening: Tear the outer bag starting from the notches (Fig. 1). Remove the inner bag from the protective packaging. Discard the outer packaging, oxygen indicator, and oxygen absorber.

Visually inspect the inner bag for any leaks. Discard any leaking bag, as sterility cannot be assured.

Mixing the bag contents and adding additional substances
To sequentially open the compartments and mix their contents, squeeze the bag with both hands, starting by opening the seal separating the upper compartment (glucose) and lower compartment (amino acids) (Fig. 2).

Then continue squeezing to open the seal between the middle compartment (lipids) and the lower compartment (Fig. 3).

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

Omegaflex special bez elektrolitów may be mixed with the following additives up to the specified maximum concentrations or total amounts indicated below. The resulting mixtures are stable for 7 days at +2°C to +8°C plus an additional 2 days at 25°C.

• Electrolytes: stability has been demonstrated in three-compartment mixtures containing 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 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 preparation.

Detailed information regarding the above-mentioned additives and appropriate shelf-lives of such mixtures is available upon request from the manufacturer.

Preparation for infusion
Before infusion, warm the emulsion to room temperature.
Remove the aluminum seal from the infusion port (Fig. 7) and connect the infusion administration set (Fig. 8). Use an infusion set without an air vent, or if using a set with an air vent, ensure it is properly closed. Hang the bag on an infusion stand (Fig. 9) and administer using standard infusion technique.

For single use only. After use, discard the packaging and any unused product.
Any unused product or waste material should be disposed of in accordance with local regulations.
Do not reconnect partially used containers.
If filters are required, they must be lipid-compatible (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 not used immediately, the user is responsible for the storage duration and conditions prior to use.

After first opening (puncturing the infusion port)
The emulsion should be used immediately after container opening.

Omegaflex special bez elektrolitów must not be mixed with other medicinal products for which compatibility has not been demonstrated.
Due to the risk of pseudoagglutination, Omegaflex special bez elektrolitów must not be administered simultaneously with blood through the same infusion set.