Omegaflex

Package leaflet: Information for the user

Omegaflex

(AA38/G120/L40 Emulsion for infusion)
Please read 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. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Omegaflex is and what it is used for

Omegaflex contains liquids and substances called amino acids, electrolytes, and fatty acids, which are essential
for the body to grow or heal. It also provides calories in the form of carbohydrates and fats.
Omegaflex is administered to adults.
Omegaflex is given to you when you are unable to eat normally. This may occur in many situations, for example after surgery, injuries or burns, or if you are unable to absorb food through the stomach and intestine.

2. What you need to know before using Omegaflex

Do not use Omegaflex

• if you are allergic to any of the active substances, to eggs, peanuts, soy, fish, or to any of the other components of this medicine (listed in section 6).
• this medicine must not be administered to neonates, infants, or children under two years of age. In addition, do not use Omegaflex if you have any of the following conditions:
• potentially life-threatening circulatory disorders, such as those occurring in cases of collapse or shock
• heart attack or stroke
• severe impairment of blood coagulation, risk of bleeding (severe coagulopathy, worsening hemorrhagic diathesis)
• blockage of blood vessels by blood clots or fat (embolism)
• severe hepatic insufficiency

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• impairment of bile flow (intrahepatic cholestasis)
• severe renal insufficiency in the absence of renal replacement therapy
• imbalances in the body's electrolyte composition
• fluid deficiency or excess water in the body
• fluid in the lungs (pulmonary edema)
• severe heart failure
• certain metabolic disorders, such as
  • excessive lipids (fats) in the blood
  • congenital disorders of amino acid metabolism
  • excessively high blood sugar levels requiring more than 6 units of insulin per hour to remain under control
  • metabolic abnormalities that may occur after surgery or trauma
  • coma of unknown origin
  • insufficient oxygen supply to tissues
  • excessively high levels of acids in the blood.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Omegaflex.
Inform your doctor if:

• you have heart, liver, or kidney problems
• you suffer from certain metabolic disorders such as diabetes, abnormal blood lipid levels, imbalances in body fluids and electrolytes, or disturbances in acid-base balance.

You will be closely monitored for early signs of an allergic reaction (such as fever, chills,
skin rash, or labored breathing) when receiving this medicine.
Additional monitoring and tests, such as various blood tests, will be performed to ensure that
your body is properly utilizing the administered nutrients.
The healthcare provider will also take appropriate measures to ensure adequate fluid and electrolyte intake
according to your needs. In addition to Omegaflex, you will receive other nutrients (food) to fully meet your
requirements.
Children
The safety and efficacy in children over 2 years of age has not yet been established. No data are
available.
This medicine must not be administered to neonates, infants, or children under two years of age.
Other medicines and Omegaflex
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take
any other medicines.
Omegaflex may interact with other medicines. Inform your doctor, pharmacist, or nurse if you are taking
or are being administered any of the following medicines:

• insulin
• heparin
• medicines that prevent inappropriate blood clotting, such as warfarin or other coumarin derivatives
• medicines that promote urine flow (diuretics)

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• medicines used to treat high blood pressure or heart problems (ACE inhibitors and angiotensin II receptor antagonists)
• medicines used in organ transplantation, such as cyclosporine and tacrolimus
• medicines used to treat inflammation (corticosteroids)
• hormonal preparations affecting fluid balance (adrenocorticotropic hormone [ACTH])

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine. If you are pregnant, you will
receive this medicine only if your doctor or pharmacist considers it essential for your recovery.
Data on the use of Omegaflex in pregnant women are not available.
Breastfeeding is not recommended for women receiving parenteral nutrition.
Driving and use of machines
This medicine is normally administered to immobilized patients, e.g., in hospital or clinic settings,
who therefore do not drive or operate machinery. In any case, this medicine has no effect on the ability to
drive or operate machinery.

3. How to use Omegaflex

This medicine is administered by intravenous infusion (drip), that is, through a small tube inserted directly into a vein. The medicine is administered exclusively into one of the large veins (central veins). The recommended duration of infusion for a parenteral nutrition bag is a maximum of 24 hours.
Your doctor or pharmacist will determine the amount of medicine you need and the duration of treatment with this medicine.

Use in children
The safety and efficacy in children older than 2 years have not been established. No data are available.
This medicine must not be administered to neonates, infants, or children under 2 years of age.

If you use more Omegaflex than you should
If you have received an excessive amount of this medicine, you may experience the so-called "overload syndrome" with the following symptoms:

• excess fluid and electrolyte disturbances
• fluid in the lungs (pulmonary edema)
• loss of amino acids in urine and disturbances in amino acid balance
• vomiting, nausea
• chills
• high blood sugar levels
• glucose in urine
• fluid deficiency

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• excessive concentration of the blood (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)
• fat deposition in internal organs
• changes in liver function parameters
• reduced number of red blood cells in the blood (anemia)
• reduced number of white blood cells in the blood (leucopenia)
• reduced number of platelets in the blood (thrombocytopenia)
• increased number of immature red blood cells (reticulocytosis)
• breakdown of blood cells (hemolysis)
• bleeding or tendency to bleed
• disturbances in blood coagulation (characterized by changes in bleeding time, coagulation time, prothrombin time, etc.)
• fever
• high levels of fats in the blood
• loss of consciousness

If any of these symptoms occur, the infusion must be stopped immediately.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects can be serious. If you experience any of the following side effects, inform your doctor immediately;
the doctor will stop administration of this medicine:
Rare (may affect up to 1 in 1,000 people):

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

Other side 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 of blood to clot
• bluish discoloration of the skin
• shortness of breath
• headache
• hot flushes
• skin redness (erythema)
• sweating
• chills

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• feeling cold
• elevated 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):
• excessively high levels of fats or sugars in the blood
• elevated levels of acidic substances in the blood
• excess of lipids may lead to lipid overload syndrome; for further information see “If you use more Omegaflex than you should” in section 3. Symptoms usually resolve upon discontinuation of the infusion. Not known (frequency cannot be estimated from the available data):
• reduced white blood cell count (leucopenia)
• reduced platelet count (thrombocytopenia)
• impairment of bile flow (cholestasis)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Omegaflex

Keep this 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. The expiry date refers to the last day of that month.
Keep the bag in its protective packaging to protect the medicine from light.

6. Contents of the package and other information

What Omegaflex contains The active substances contained in the ready-to-use mixture are:

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The other components are citric acid monohydrate (to adjust pH), egg lecithin, glycerol, sodium oleate,
all-rac-alpha-tocopherol, sodium hydroxide (to adjust pH), and water for injections.
Description of the appearance of Omegaflex and contents of the pack
The ready-to-use product is an infusion emulsion, meaning it is administered through a tube inserted into a vein.
Omegaflex is supplied in flexible multi-compartment bags containing:

• 1,250 ml (500 ml of amino acid solution + 250 ml of lipid emulsion + 500 ml of glucose solution)
• 1,875 ml (750 ml of amino acid solution + 375 ml of lipid emulsion + 750 ml of glucose solution)
• 2,500 ml (1,000 ml of amino acid solution + 500 ml of lipid emulsion + 1,000 ml of glucose solution)

Figure A Figure B
Figure A: the multi-compartment bag is enclosed in a protective overwrap. Between the bag and the overwrap there are an oxygen absorber and an oxygen indicator; the oxygen absorber sachet is made of inert material and contains ferrous hydroxide.
Figure B: the upper compartment contains a glucose solution, the middle compartment contains a lipid emulsion, and the lower compartment contains an amino acid solution.
The glucose and amino acid solutions are clear and colourless to pale yellow. The lipid emulsion is white and opalescent in appearance.
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The upper and middle compartments can be connected to the lower compartment by opening the intermediate seals.
Different container sizes are packaged in boxes containing five bags.
Pack sizes: 5 x 1.250 ml, 5 x 1.875 ml and 5 x 2.500 ml
It is possible that not all pack sizes are marketed.
Marketing Authorisation Holder and Manufacturer
B. Braun Melsungen AG
Carl-Braun-Straße 1 Postal address:
34212 Melsungen, Germany 34209 Melsungen, Germany
Telephone: +49-5661-71-0
Fax: +49-5661-71-4567
This medicinal product is authorised in the European Economic Area Member States under the following
names:
Austria Nutriflex Omega plus B.Braun Emulsion zur Infusion
Belgium Nutriflex Omega plus 38 g/l Amino120 g/l G, emulsie voor infusie
Bulgaria Nutriflex Omega 38/120 plus emulsion for infusion
Croatia Nutriflex Omega 38/120 plus emulzija za infuziju
Cyprus Nutriflex Omega 38/120 plus γαλάκτωμα για έγχυση
Czech Republic Nutriflex Omega plus 38/120, infuzní emulze
Denmark Nutriflex Omega Plus
Finland Nutriflex Omega 38/120/40 infuusioneste, emulsio
France MEDNUTRIFLEX OMEGA E, émulsion pour perfusion
Germany Nutriflex Omega plus novo Emulsion zur Infusion
Greece Nutriflex Omega 38/120 plus
Ireland Nutriflex Omega 38/120 plus Emulsion for Infusion
Italy Omegaflex
Luxembourg Nutriflex Omega plus novo Emulsion zur Infusion
Netherlands Nutriflex Omega plus, 38 g/l Amino + 120 g/l G, emulsie voor infusie
Norway Nutriflex Omega Plus infusjonsvæske, emulsjon
Poland Nutriflex Omega 38/120 plus
Portugal Nutriflex Omega 38/120 P emulsão para perfusão
Romania NuTRIflex Omega Plus novo, emulsie perfuzabilă
Slovakia Nutriflex Omega 38/120 plus, infúzna emulzia
Spain Omegaflex plus emulsión para perfusión
Sweden Nutriflex Omega 38/120/40 infusionsvätska, emulsion
United Kingdom Omega Plus 38/120
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______________________________________________________________________________
The following information is intended for healthcare professionals only:
No special instructions for disposal.
Before use, parenteral nutrition products must be visually inspected for damage, discolouration and emulsion instability.
Do not use damaged bags. The overwrap, primary bag and compartment seals must be intact. Use only if the amino acid and glucose solutions are clear and colourless to pale yellow and if the lipid emulsion is homogeneous and white and opalescent. Do not use if the solutions contain particles.
After mixing the three compartments, do not use if the emulsion shows discolouration or signs of phase separation (oil droplets, oily layer). Immediately discontinue infusion in case of discolouration or signs of phase separation.
Before opening the overwrap, check the colour of the oxygen indicator (see Figure A). Do not use if the oxygen indicator is pink. Use only if the oxygen indicator is yellow.
Preparation of the emulsion by mixing
Aseptic procedures must be strictly followed.
To open: tear the overwrap starting from the designated slits (Fig. 1). Remove the bag from the protective overwrap. Discard the overwrap, oxygen indicator and oxygen absorber.
Visually inspect the primary bag for leaks. Leaking bags must be discarded, as sterility cannot be guaranteed.

To open and progressively mix the compartments, roll the bag with both hands, pressing on the seal separating the upper compartment (glucose) from the lower compartment (amino acids) (Fig. 2a). Continue pressing until the seal between the middle compartment (lipids) and the lower compartment is opened (Fig. 2b).
Addition of additives
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After removing the aluminium cap (Fig. 3), compatible additives may be added through the medication addition port (Fig. 4).
Omegaflex may be mixed with the following additives up to the maximum concentration limits specified below or to the maximum amount of additives after addition. The resulting mixtures are stable for 7 days at +2°C to +8°C plus 2 days at 25°C.

• Electrolytes: consider the amount of electrolytes already present in the bag; 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 of inorganic phosphate.
• Alanyl-glutamine up to 24 g/l.
• Trace elements and vitamins: stability has been demonstrated with commercially available multi-trace elements and multi-vitamins (e.g. Olitrace, Cernevit) up to the standard dosage recommended by the respective micronutrient formulation manufacturer.

Detailed information on the above-mentioned additives and the corresponding shelf life of such mixtures can be provided upon request by the manufacturer.

Carefully mix the contents of the bag (Fig. 5) and visually inspect the mixture (Fig. 6). No signs of emulsion phase separation should be visible.
The mixture is a homogeneous oil-in-water emulsion, white and opalescent in appearance.
Preparation of infusion
The emulsion must always be brought to room temperature before infusion.
Remove the aluminium film from the infusion port (Fig. 7) and connect the infusion set (Fig. 8).
Use a non-vented infusion set or close the air vent if a vented set is used. Hang the bag on an IV pole (Fig. 9) and administer the infusion according to standard technique.
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For single use only. The container and any unused residues must be discarded after use. Do not reconnect a partially used container.
If filters are used, they must be lipid-permeable (pores ≥1.2 µm).
Shelf life after removal of the protective overwrap and mixing of the bag contents
Chemical and physicochemical stability of the mixture of amino acids, glucose and fats has been demonstrated for 7 days at 2–8°C and an additional 2 days at 25°C.
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 additive addition, the user is responsible for the storage times and conditions during use.
After first opening (puncture of the infusion port)
The emulsion must be used immediately after opening the container.
Omegaflex must not be mixed with other medicinal products for which compatibility has not been documented. Compatibility data for various additives (e.g. electrolytes, trace elements, vitamins) and shelf life for these mixtures can be provided upon request by the manufacturer.
Omegaflex must not be administered simultaneously with blood through the same infusion set due to the risk of pseudoagglutination.
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