OMEGAPRO 625 ML Emulsja do infuzji dożylnej

Treść ulotki

1. Omegapro (AA56/G144/L40 Emulsion for infusion)
   1. What Omegapro is and what it is used for
   2. What you need to know before using Omegapro
   3. How to use Omegapro
   4. Possible side effects
   5. How to store Omegapro
   6. Contents of the pack and other information

Omegapro (AA56/G144/L40 Emulsion for infusion)

Read this leaflet carefully before using this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Omegapro is and what it is used for

Omegapro contains liquids and substances called amino acids, electrolytes and fatty acids, which are essential
for the body to grow or heal. It also contains calories in the form of carbohydrates and fats.
Omegapro is administered to adults.
Omegapro is administered to you when you are unable to feed yourself normally. This can happen in
many situations, for example after surgery, injuries or burns, or if you are unable to absorb
food in the stomach and intestines.

2. What you need to know before using Omegapro

Do not use Omegapro

• if you are allergic to any of the active ingredients, 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 newborns, infants and children under two years of age. Also, do not use Omegapro if you suffer from any of the following conditions:
• potentially life-threatening disorders of blood circulation, such as those that may occur in case of collapse or shock
• heart attack or stroke
• severe impairment of blood coagulation, risk of bleeding (severe coagulopathy, worsening haemorrhagic diathesis)
• obstruction of blood vessels by blood clots or fat (embolism)
• severe liver failure
• impaired bile flow (intrahepatic cholestasis)
• severe kidney failure in the absence of renal replacement therapy
• imbalances in the salt content in the body
• deficiency of fluids or excess of water in the body
• water in the lungs (pulmonary edema)

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• severe heart failure
• certain metabolic disorders, such as
• too many lipids (fats) in the blood
• congenital disorders of amino acid metabolism
• levels of sugar in the blood that are too high and require more than 6 units of insulin per hour to keep under control
• metabolic abnormalities that may occur after surgery or injury
• coma of unknown origin
• insufficient oxygen supply to the tissues
• too high levels of acids in the blood.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Omegaflex AA56/G144.
Tell your doctor if:

• you have problems with your heart, liver or kidneys
• you suffer from certain metabolic disorders such as diabetes, abnormal fat levels in the blood and imbalances in fluid and salt content in the body or alterations in acid-base balance. You will be carefully monitored for early signs of an allergic reaction (such as fever, chills, rash or shortness of breath) when you receive this medicine.

Other checks and tests, such as various tests performed on blood samples, will be used to verify that
the body uses the administered nutrients correctly.
The healthcare professional will also take appropriate measures to ensure adequate fluid and electrolyte supply to
your needs. In addition to Omegapro, you will receive other nutrients (food) to fully cover your
needs.

Children
Safety and efficacy in children over 2 years of age have not yet been established. No data are
available.
This medicine must not be administered to newborns, infants and children under two years of age.

Other medicines and Omegapro
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take
any other medicine.
Omegapro can interact with other medicines. Tell your doctor, pharmacist or nurse if you are taking or
are given 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)
• 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 that affect fluid balance (adrenocorticotropic hormone [ACTH])

Pregnancy and breastfeeding
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If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. If you are pregnant, you will
receive this medicine only if your doctor or pharmacist considers it essential for recovery. No
data are available regarding the use of Omegapro in pregnant women.
Breastfeeding is not recommended for women receiving parenteral nutrition.

Driving and operating machinery
This medicine is normally administered to immobilized patients, e.g. in hospital or clinic,
who therefore do not drive or operate machinery. In any case, the medicine has no effects on the ability to
drive vehicles or operate machinery.

Omegapro contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per multi-compartment bag, i.e. it is practically
“sodium-free”.

3. How to use Omegapro

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

Use in children and adolescents
Safety and efficacy in children over 2 years of age have not been established. No data are
available.
This medicine should not be administered to newborns, infants and children under two years of age.

If you use more Omegapro than you should
If you have received an excessive amount of this medicine, you may suffer from 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 the urine and disturbances of amino acid balance
• vomiting, nausea
• shivering
• high blood sugar levels
• glucose in the urine
• fluid deficit
• excessive blood concentration (hyperosmolarity)
• alteration 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)

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• fat deposition in internal organs
• alterations in liver function parameters
• reduction in the number of red blood cells in the blood (anemia)
• reduction in the number of white blood cells in the blood (leukopenia)
• reduction in the number of platelets in the blood (thrombocytopenia)
• increase in immature red blood cells (reticulocytosis)
• breakdown of blood cells (hemolysis)
• bleeding or tendency to bleed
• blood coagulation disorders (characterized by alterations 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, ask your doctor or pharmacist.

4. Possible side effects

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

The following side effects may be serious. If any of the following side effects occur,
inform your doctor immediately, who will stop giving you 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 the blood to clot
• bluish discoloration of the skin
• shortness of breath
• headache
• hot flushes
• redness of the skin (erythema)
• sweating
• shivering
• feeling of 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):

• excessive levels of fats or sugars in the blood

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• high levels of acidic substances in the blood
• An excess of lipids can lead to a lipid overload syndrome; for more information see “If you use more Omegapro than you should” in section 3. Symptoms generally disappear when the infusion is stopped. Not known (frequency cannot be estimated from available data):
• decreased white blood cell count (leukopenia)
• decreased platelet count (thrombocytopenia)
• impaired bile flow (cholestasis)

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
You can also report side effects directly through 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 Omegapro

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

6. Contents of the pack and other information

What Omegaflex AA56/G144 contains
The active ingredients contained in the ready-to-use mixture are:

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Other ingredients are citric acid monohydrate (to adjust the pH), egg lecithin, glycerol, sodium oleate,
all-rac-alpha-tocopherol, sodium hydroxide (to adjust the pH) and water for injections.

Description of the appearance of Omegapro and contents of the pack
The ready-to-use product is an emulsion for infusion, i.e. it is administered through a tube inserted
into a vein.
Omegapro is supplied in flexible multi-compartment bags containing:

• 625 ml (250 ml of amino acid solution + 125 ml of lipid emulsion + 250 ml of glucose solution)
• 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)

Figure A Figure B
Figure A: the multi-compartment bag is wrapped in a protective packaging. Between the bag and the packaging there 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 compartment contains a glucose solution, the intermediate compartment contains
a lipid emulsion and the lower compartment contains an amino acid solution.
The glucose and amino acid solutions are clear and colorless to straw yellow. The lipid emulsion is
milky white in appearance.
The upper and intermediate compartments can be connected to the lower compartment by opening the
intermediate seals.
The different container sizes are packaged in boxes containing five bags.
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Pack sizes: 5 x 625 ml, 5 x 1,250 ml and 5 x 1,875 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder

• 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

Manufacturer

• B. Braun Melsungen AG LIFE Nutrition, Plant P Am Schwerzelshof 1 34 212 Melsungen Germany

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:
Austria Nutriflex Omega special B.Braun Emulsion zur Infusion
Belgium Nutriflex Omega special, 56 g/l Amino + 144 g/l G, emulsie voor infusie
Bulgaria Nutriflex Omega 56/144 special emulsion for infusion
Croatia Nutriflex Omega 56/144 specijal emulzija za 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 Omegapro
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 Nutriflex Omega 56/144 S 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 Omegaflex especial emulsión para perfusión
Sweden Nutriflex Omega 56/144/40 infusionsvätska, emulsion
United Kingdom Omeflex special emulsion for infusion
______________________________________________________________________________
The following information is intended exclusively for physicians or healthcare professionals:
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No particular instructions for disposal.
Before use, parenteral nutrition medicines must be visually inspected for any damage, colour changes and emulsion instability.
Do not use damaged bags. The outer packaging, primary bag and internal seals located between the compartments
must be intact. Use only if the amino acid and glucose solutions are clear and colourless to straw-yellow and if the lipid emulsion is homogeneous and milky white in appearance. Do not use if the solutions
contain particles.
After mixing the three compartments, do not use if the emulsion shows colour changes or obvious signs of
phase separation (oil droplets, oily layer). Immediately stop the infusion if changes in the emulsion colour or obvious signs of phase separation are observed.
.
Before opening the outer packaging, 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
Strict adherence to the rules for aseptic procedures is essential.
To open: tear the outer packaging starting from the designated notches (Fig. 1). Remove the bag from the protective packaging. Discard the outer packaging, oxygen indicator and oxygen absorber.
Visually inspect the primary bag for any leaks. Bags that leak must be
discarded, as sterility cannot be guaranteed in this case.

To open and gradually 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). Then
continue to press until the seal separating the intermediate compartment (lipids) from the
lower compartment is opened (Fig. 2b).
Addition of additives
After removing the aluminium seal (Fig. 3), additives compatible with the formulation can be added through the
port intended for adding medications (Fig. 4).
Omegapro can be mixed with the following additives up to the upper concentration limits or the maximum amount of additives after integration specified below. The produced mixtures are stable for 7 days between +2 °C and +8 °C plus 2 days at 25 °C.
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• Electrolytes: take into account the electrolytes already present in the bag; stability has been demonstrated up to a maximum total amount 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.
• Alanil-glutamine up to 24 g/l.
• Trace elements and vitamins: stability has been demonstrated with commercially available multi-trace element and multi-vitamin products (e.g. Tracutil, Cernevit) up to the standard dosage recommended by the respective manufacturers of the micronutrient-based formula per litre in the mixture.

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

Carefully mix the contents of the bag (Fig. 5) and visually inspect the mixture (Fig. 6). No
signs of phase separation of the emulsion should be visible.
The mixture is a homogeneous oil-in-water emulsion, milky white in appearance.

Preparation of the infusion
The emulsion must always be brought to room temperature before infusion.
Remove the aluminium foil 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 infusion pole (Fig. 9) and administer the infusion according to standard technique.

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For single use only. The container and any unused residue must be discarded after use.
Do not reconnect a partially used container.
If filters are used, they must be lipid-permeable (pore size ≥1.2 µm).

Shelf life after removal of the protective packaging and mixing of the bag contents
The chemical and physical stability of the amino acid, glucose and lipid mixture during use has been demonstrated for
7 days at 2-8 °C and for a further 2 days at 25 °C.

Shelf life after addition of compatible additives
From a microbiological point of view, the product must be used immediately after the addition of additives.
If the product is not used immediately after the addition of additives, the user is responsible for the
storage times and conditions during use.

After first opening (piercing the infusion port)
The emulsion must be used immediately after opening the container.
Omegapro must not be administered simultaneously with blood in the same infusion set due to the
risk of pseudoagglutination.
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