Omegapro

Package leaflet: Information for the user

Omegapro (AA56/G144/L40 Emulsion for infusion)

Read this entire leaflet carefully before 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 adverse reactions, including those not listed in this leaflet, contact 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 using 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 provides calories in the form of carbohydrates and fats.
Omegapro is administered to adults.
You are given Omegapro when you are unable to eat normally. This may occur in various situations, for example after surgery, trauma, or burns, or if you are unable to absorb food through the stomach and intestine.

2. What you should know before using Omegapro

Do not use Omegapro

• if you are allergic to any of the active substances, to eggs, peanuts, soy, fish, or to any of the other ingredients of this medicine (listed in section 6).
• This medicine must not be administered to newborns, infants, or children under two years of age. In addition, do not use Omegapro if you have any of the following conditions:
• potentially life-threatening circulatory disorders, such as those occurring in case 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 liver failure
• impaired bile flow (intrahepatic cholestasis)
• severe renal failure without renal replacement therapy
• imbalances in the body's electrolyte levels
• fluid deficiency or excess water in the body
• fluid 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
  • excessively high blood sugar levels requiring more than 6 units of insulin per hour to be controlled
  • 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 AA56/G144.
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, rash, or shortness of breath) when receiving this medicine.

Other checks and tests, such as various blood tests, will be performed to ensure that
your body is properly utilizing the nutrients administered.
Your healthcare provider will also take appropriate measures to ensure adequate fluid and electrolyte intake
according to your needs. In addition to Omegapro, you will receive other nutritional substances (nutrients) to fully meet your
requirements.
Children
The 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, or children under two years of age.
Other medicines and Omegapro
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take
any other medicine.
Omegapro 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)
• 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
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If you are pregnant, suspect you may be pregnant, planning a pregnancy, or 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 recovery.
There are no data available on the use of Omegapro in pregnant women.
Breastfeeding is not recommended for women receiving parenteral nutrition.
Driving and using 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.
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 by intravenous infusion (intravenous drip), meaning through a small tube inserted directly into a vein. The medicine must be administered exclusively into one of the large veins (central veins). The recommended infusion duration 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 and adolescents
The safety and efficacy in children older than 2 years have not been established. There are no available data.
This medicine must not be administered to neonates, infants, or children under 2 years of age.

If you use more Omegapro 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 the urine and disturbances in amino acid balance
• vomiting, nausea
• chills
• high blood sugar levels
• glucose in the urine
• fluid deficit
• excessive concentration of the blood (hyperosmolarity)
• altered or lost 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 red blood cell count in the blood (anaemia)
• reduced white blood cell count in the blood (leucopenia)
• reduced platelet count in the blood (thrombocytopenia)
• increase in immature red blood cells (reticulocytosis)
• breakdown of blood cells (haemolysis)
• bleeding or tendency to bleed
• disturbances in blood coagulation (characterized by changes in bleeding time, coagulation time, prothrombin time, etc.)
• fever
• high levels of fat 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.

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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects can be serious. If you experience any of the following side effects, inform your doctor immediately;
the doctor will discontinue 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
• feeling cold
• elevated body temperature
• drowsiness
• chest, back, bone or lower back pain
• decreased or increased blood pressure

Very rare (may affect up to 1 in 10,000 people):

• excessively high levels of fats or sugars in the blood

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• elevated levels of acidic substances in the blood

• An excess of lipids may lead to a lipid overload syndrome; for further information see “If you use more Omegapro 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 (leukopenia)

• 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 the following website: 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 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 the protective outer packaging to protect the medicine from light.

6. Contents of the pack and other information

What Omegaflex AA56/G144 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-tocoferol, sodium hydroxide (to adjust pH), and water for injections.
Description of the appearance of Omegapro and contents of the pack
The ready-to-use product is an infusion emulsion, meaning it is administered through a small 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 enclosed in a protective overwrap. Between the bag and the overwrap there are an oxygen absorber and an oxygen indicator; the sachet of the oxygen absorber is made of inert material and contains iron 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 a white, milky-looking emulsion.
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.
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Pack sizes: 5 x 625 ml, 5 x 1.250 ml and 5 x 1.875 ml
It is possible that not all pack sizes are marketed.
Marketing Authorization 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
34212 Melsungen
Germany
This medicinal product is authorized in the European Economic Area Member States under the following
names:
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 special instructions for disposal.
Before use, parenteral nutrition medicines must be visually inspected for any damage, colour changes, or emulsion instability.
Do not use damaged bags. The overwrap, primary bag, and internal seals between compartments 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 appears white and milky. 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 discontinue infusion if colour changes in the emulsion or obvious signs of phase separation are observed.
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 any 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). Then continue pressing until the seal between the middle compartment (lipids) and the lower compartment opens (Fig. 2b).
Addition of additives
After removing the aluminium closure (Fig. 3), compatible additives may be added through the medication addition port (Fig. 4).
Omegapro may be mixed with the following additives up to the upper concentration limits or maximum amounts of additives after integration specified below. The resulting mixtures are stable for 7 days at +2 °C to +8 °C plus 2 days at 25 °C.
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• Electrolytes: take into account electrolytes already present in the bag; stability has been demonstrated up to a total maximum of 200 mmol/l of sodium + potassium (combined), 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 commercially available multi-trace element and multivitamin products (e.g. Tracutil, Cernevit) up to the standard dosage recommended by the respective manufacturers of the micronutrient formulation per litre in the mixture.

Detailed information on the above 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 emulsion phase separation should be visible.
The mixture is a homogeneous oil-in-water emulsion, appearing white and milky.
Preparation of the 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 using a vented set. 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 (pore size ≥1.2 µm).
Shelf life after removal of the protective overwrap and mixing of the bag contents
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 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 addition of additives, the user is responsible for the storage times and conditions during use.
After first opening (perforation of the infusion port)
The emulsion must be used immediately after opening the container.
Omegapro must not be mixed with other medicinal products for which compatibility has not been documented.
Omegapro must not be administered simultaneously with blood through the same infusion set due to the risk of pseudoagglutination.
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