Nutriflex Omega Plus Emulsion For Infusion


Package leaflet: Information for the user

M Nutriflex® Omega plus

emulsion for infusion

Approval for Printing

BlBRAUN Melsungen AG

Approved for Printing

Approved for Printing when corrected

New draft required

Read all of 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 further questions, ask your doctor, pharmacist or nurse.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.



Name in capital letters


What is in this leaflet

1.    What Nutriflex® Omega plus is and what it is used for

2.    What you need to know before you use Nutriflex® Omega plus

3.    How to use Nutriflex® Omega plus

4.    Possible side effects

5.    How to store Nutriflex® Omega plus

6.    Contents of the pack and other information

1. What Nutriflex® Omega plus is and what it is used for

Nutriflex® Omega plus contains substances called amino acids, electrolytes and fatty acids that are essential for the body to grow or to recover. It also contains calories in the form of carbohydrates and fats.

You are given Nutriflex® Omega plus when you are unable to eat food normally. There are many situations when this might be the case, for example when you are recovering from surgery, injuries, or burns, or when you are unable to absorb food from your stomach and gut.

2. What you need to know before you use Nutriflex® Omega plus

Do not use Nutriflex® Omega plus

•    if you are allergic to egg, peanut, soybean or fish or any of the other ingredients of this medicine (listed in section 6).

•    This medicine must not be given to newborn infants, infants and toddlers under two years old.

Also, do not use Nutriflex® Omega plus if you suffer from any of the following:

•    life-threatening blood circulation problems such as those that can occur if you are in a state of collapse or shock

•    heart attack or stroke

•    severely impaired blood clotting function (bleeding risk)

•    blocking of blood vessels by blood clots or fat (embolism)

•    severe liver failure

•    impaired bile flow (intrahepatic cholestasis)

•    severe kidney failure where no dialysis facilities are available

•    disturbances of your body salt composition

•    fluid deficit or excess water in your body

•    water on your lungs (pulmonary oedema)

•    severe heart failure

•    certain metabolic disorders such as

-    too much lipid (fat) in the blood

-    inborn errors of amino acid metabolism

-    abnormally high blood sugar level that needs more than 6 units of insulin per hour to be controlled

-    abnormalities of metabolism that may occur after operations or injuries

-    coma of unknown origin

-    insufficient supply of oxygen to tissues

-    abnormally high acid level in the blood.

Warnings and precautions

Talk to your doctor before using Nutriflex® Omega plus.

Please inform your doctor if:

•    you have heart, liver or kidney problems

•    you suffer from certain types of metabolic disorders such as diabetes, abnormal blood fat values and disorders of your body fluid and salt composition

•    your blood clotting function is impaired or if your vitamin K level might be too low.

You will be monitored closely to detect early signs of an allergic reaction (such as fever, shivering, rash, or shortness of breath) when you receive this medicine.

Further monitoring and tests such as various examinations of blood samples will be applied to make sure that your body handles the administered foodstuffs properly.

The nursing staff may also take measures to ensure that your body's fluid and electrolyte requirements are met. In addition to Nutriflex® Omega plus you may receive further nutrients (foodstuffs) in order to fully cover your requirements.

Children and adolescents

Safety and efficacy in children and adolescents have not been established. This medicine must not be given to newborn infants, infants and toddlers under two years old.

Other medicines and Nutriflex® Omega plus

Tell your doctor if you are taking, have recently taken or might take any other medicines.

Nutriflex® Omega plus can interact with some other medicines. Please tell your doctor if you are taking or receiving any of the following:

•    insulin

•    heparin

•    medicines that prevent undesirable blood clotting such as warfarin or other coumarin derivatives

•    medicines to promote urine flow (diuretics)

•    medicines to treat high blood pressure or heart problems (ACE-inhibitors and angiotensin-II-receptor antagonists)

•    medicines used in organ transplants such as cyclosporin and tacrolimus

•    medicines to treat inflammation (corticosteroids)

•    hormone preparations that affect your fluid balance (adrenocorticotropic hormone [ACTH]).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. If you are pregnant you will receive this medicine only if the doctor considers it absolutely necessary for your recovery. There is no data available about the use of Nutriflex® Omega plus in pregnant women.

Breast-feeding is not recommended for mothers on parenteral nutrition.

Driving and using machines

Nutriflex® Omega plus is normally given to immobile patients in a hospital or clinic. This will exclude driving and using machines.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

If you use more Nutriflex® Omega plus than you should

If you have received too much of this medicine you may suffer from a so-called 'overload syndrome' and the following symptoms:

•    fluid excess and electrolyte disorders

•    water on your lungs (pulmonary oedema)

•    loss of amino acids through the urine and disturbed amino acid balance

•    vomiting, feeling sick

•    shivering

•    high blood sugar level

•    glucose in the urine

•    fluid deficit

•    blood much more concentrated than normal (hyperosmolality)

•    impairment or loss of consciousness due to extremely high blood sugar

•    enlargement of the liver (hepatomegaly) with and without jaundice (icterus)

•    enlargement of the spleen (splenomegaly)

•    fat deposition in the inner organs

•    abnormal values of liver function tests

•    reduction of red blood cell count (anaemia)

•    reduction of white blood cell count (leukopenia)

•    reduction of blood platelet count (thrombocytopenia)

•    increase of immature red blood cells (reticulocytosis)

•    rupture of blood cells (haemolysis)

•    bleeding or a tendency to bleeding

•    impairment of blood coagulation (as can be seen by changes of bleeding time, coagulation time, prothrombin time etc.)

•    fever

•    high blood fat levels

•    loss of consciousness

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

Latus 1398

Format = 210 x 594 mm 2 Seiten


Nutriflex® Omega plus 170/12609620/0815 GIF - 3KB

Standort Melsungen

Font size: 9,5 pt.

G 121712

4. Possible side effects

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

The following side effects may be serious. If any of the following side effects occur, tell your doctor immediately, he will stop giving you this medicine:

Rare (affects 1 to 10 users in 10,000):

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

Other side effects include:

Uncommon (affects 1 to 10 users in 1,000):

•    feeling sick, vomiting, loss of appetite Rare (affects 1 to 10 users in 10,000):

•    increased tendency for your blood to clot

•    bluish discolouration of the skin

•    shortness of breath

•    headache

•    flushing

•    reddening of skin (erythema)

•    sweating

•    chills

•    feeling cold

•    high body temperature

•    drowsiness

•    pain in the chest, back, bones or lumbar region

•    decrease or increase in blood pressure Very rare (affects less than 1 user in 10,000):

•    abnormally high blood fat or blood sugar values

•    high levels of acidic substances in your blood

•    Too much lipid can lead to fat overload syndrome, for more information on this please see under the heading "If you use more Nutriflex® Omega plus than you should" in section 3. Symptoms normally disappear when the infusion is stopped.

Reporting of side effects:

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly via the:

United Kingdom: Yellow Card Scheme at Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website:; e-mail:

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Nutriflex® Omega plus

Keep this medicine out of the sight and reach of children.

Do not store above 25 °C. Keep the bags in the outer carton in order to protect from light.

Do not freeze. If accidentally frozen, discard the bag.

Do not use this medicine after the expiry date which is stated on the label.

6. Contents of the pack and other information

What Nutriflex® Omega plus contains

The active substances in the ready-for-use mixture are:

from the upper, left-hand chamber (glucose solution)


1000 ml


1250 ml


1875 ml


2500 ml

Glucose monohydrate equivalent to anhydrous glucose

132.0    g

120.0    g

165.0    g

150.0    g

247.5 g 225.0 g

330.0    g

300.0    g

Sodium dihydrogen phosphate dihydrate

1.872 g

2.340 g

3.510 g

4.680 g

Zinc acetate dihydrate

5.264 mg

6.580 mg

9.870 mg

13.16 mg

3. How to use Nutriflex® Omega plus

This medicine is administered by intravenous infusion (drip), that is, through a small tube directly into a vein. This medicine will be administered through one of your large (central) veins only.

Your doctor will decide how much of this medicine you need and for how long you will require treatment with this medicine.

Use in children and adolescents

Safety and efficacy in children and adolescents have not been established. This medicine must not be given to newborn infants, infants and toddlers under two years old.

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from the upper, right-hand chamber (fat emulsion)


1000 ml


1250 ml


1875 ml


2500 ml



20.00 g

25.00 g

37.50 g

50.00 g

Soya-bean oil refined

16.00 g

20.00 g

30.00 g

40.00 g



4.000 g

5.000 g

7.500 g

10.00 g


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from the lower chamber (amino acid solution)


1000 ml


1250 ml


1875 ml


2500 ml


2.256 g

2.820 g

4.230 g

5.640 g


3.008 g

3.760 g

5.640 g

7.520 g

Lysine hydrochloride

2.728 g

3.410 g

5.115 g

6.820 g

equivalent to lysine

2.184 g

2.729 g

4.094 g

5.459 g


1.880 g

2.350 g

3.525 g

4.700 g


3.368 g

4.210 g

6.315 g

8.420 g


1.744 g

2.180 g

3.270 g

4.360 g


0.544 g

0.680 g

1.020 g

1.360 g


2.496 g

3.120 g

4.680 g

6.240 g


2.592 g

3.240 g

4.860 g

6.480 g

Histidine hydrochloride monohydrate

1.624 g

2.030 g

3.045 g

4.060 g

equivalent to histidine

1.202 g

1.503 g

2.254 g

3.005 g


4.656 g

5.820 g

8.730 g

11.64 g

Aspartic acid

1.440 g

1.800 g

2.700 g

3.600 g

Glutamic acid

3.368 g

4.210 g

6.315 g

8.420 g


1.584 g

1.980 g

2.970 g

3.960 g


3.264 g

4.080 g

6.120 g

8.160 g


2.880 g

3.600 g

5.400 g

7.200 g

Sodium hydroxide

0.781 g

0.976 g

1.464 g

1.952 g

Sodium chloride

0.402 g

0.503 g

0.755 g

1.006 g

Sodium acetate trihydrate

0.222 g

0.277 g

0.416 g

0.554 g

Potassium acetate

2.747 g

3.434 g

5.151 g

6.868 g

Magnesium acetate tetrahydrate

0.686 g

0.858 g

1.287 g

1.716 g

Calcium chloride dihydrate

0.470 g

0.588 g

0.882 g

1.176 g



1000 ml


1250 ml


1875 ml


2500 ml


40 mmol

50 mmol

75 mmol

100 mmol


28 mmol

35 mmol

52.5 mmol

70 mmol


3.2 mmol

4.0 mmol

6.0 mmol

8.0 mmol


3.2 mmol

4.0 mmol

6.0 mmol

8.0 mmol


0.024 mmol

0.03 mmol

0.045 mmol

0.06 mmol


36 mmol

45 mmol

67.5 mmol

90 mmol


36 mmol

45 mmol

67.5 mmol

90 mmol


12 mmol

15 mmol

22.5 mmol

30 mmol

Amino acid content

38 g

48 g

72 g

96 g



5.4 g

6.8 g

10.2 g

13.6 g



120 g

150 g

225 g

300 g

Lipid content

40 g

50 g

75 g

100 g

What Nutriflex® Omega plus looks like and contents of the pack

The ready-to-use product is an emulsion for infusion, i.e. it is administered through a small tube into a vein.

Nutriflex® Omega plus is supplied in flexible multichamber bags containing:

•    1250 ml (500 ml of amino acids solution + 250 ml of fat emulsion + 500 ml of glucose solution)

•    1875 ml (750 ml of amino acids solution + 375 ml of fat emulsion + 750 ml of glucose solution)

•    2500 ml (1000 ml of amino acids solution + 500 ml of fat emulsion + 1000 ml of glucose solution)

The glucose and the amino acid solutions are clear and colourless up to straw-coloured. The fat emulsion is milky-white.

The multichamber bag is packed in a protective overwrap. An oxygen absorber is placed between the bag and the overwrap.

The two upper chambers can be connected with the lower chamber by opening the intermediate seam.

The different container sizes are presented in cartons containing five bags.

Pack sizes: 5 x 1250 ml, 5 x 1875 ml and 5 x 2500 ml Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

B. Braun Melsungen AG

Carl-Braun-StraBe 1    Postal address:

34212 Melsungen, Germany    34209 Melsungen, Germany

Phone: +49-5661-71-0 Fax: +49-5661-71-4567

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria    NuTRIflex Omega    plus

Belgium    NuTRIflex Omega    plus

Bulgaria    NuTRIflex Omega    plus

Cyprus    NuTRIflex Omega    plus

Czech Republic NuTRIflex Omega    plus

Denmark    Nutriflex Omega plus

Estonia    NuTRIflex Omega

Finland    Nutriflex Omega plus

France    Mednutriflex Omega G 120/N 5,4/E

Germany    NuTRIflex Omega    plus

Greece    NuTRIflex Omega    plus

Hungary    NuTRIflex Omega    plus

Ireland    Nutriflex® Omega plus

Italy    Nutriplus Omega

Latvia    NuTRIflex Omega

Lithuania    NuTRIflex Omega

Luxembourg    NuTRIflex Omega    plus

Netherlands    NuTRIflex Omega    plus

Norway    Nutriflex Omega plus

Poland    NuTRIflex Omega    plus

Portugal    NuTRIflex Omega    P

Romania    NuTRIflex Omega    plus

Slovakia    NuTRIflex Omega    plus

Slovenia    Nutriflex Omega G 120/N5,4/E

Spain    NuTRIflex Omega    plus

Sweden    Nutriflex Omega plus

United Kingdom Nutriflex® Omega plus

This leaflet was last revised in July 2015

Energy in the form of lipid

1590 kJ (380 kcal)

1990 kJ (475 kcal)

2985 kJ (715 kcal)

3980 kJ (950 kcal)

Energy in the form of carbohydrates

2010 kJ (480 kcal)

2510 kJ (600 kcal)

3765 kJ (900 kcal)

5020 kJ (1200 kcal)

Energy in the form of amino acids

635 kJ (150 kcal)

800 kJ (190 kcal)

1200 kJ (285 kcal)

1600 kJ (380 kcal)



3600 kJ (860 kcal)

4500 kJ (1075 kcal)

6750 kJ (1615 kcal)

9000 kJ (2155 kcal)

Total energy

4235 kJ (1010 kcal)

5300 kJ (1265 kcal)

7950 kJ (1900 kcal)

10600 kJ (2530 kcal)

The following information is intended for healthcare professionals only:

Nutriflex® Omega plus is supplied in containers for single use. Discard container and any unused content after use.

Do not re-connect partially used containers.

Only use bags that are undamaged and in which the amino acid and glucose solutions are clear, colourless up to straw-coloured solutions. Do not use bags where there is a discolouration or discernible phase separation (oil drops) in the chamber containing the lipid emulsion.

If filters are used they must be lipid-permeable.





















5.0 - 6.0

5.0 - 6.0

5.0 - 6.0

5.0 - 6.0

The other ingredients are citric acid monohydrate, egg lecithin, glycerol, sodium oleate, all-rac-a-tocopherol, sodium hydroxide for pH adjustment and water for injections.

Preparation of the mixed emulsion:

Remove inner bag from its protective overwrap and proceed as follows:

•    put the bag on a solid, flat surface

•    mix glucose with amino acids by pressing the upper left chamber against the peel seam, then add the fat emulsion by pressing the upper right chamber against the peel seam

•    mix the contents of the bag thoroughly.

Preparation for infusion:

•    fold the bag and hang it on the infusion stand by the centre hanging loop

•    remove the protective cap from the infusion port and carry out infusion using the standard technique.

The mixture is a milky white homogenous oil-in-water emulsion.

The emulsion should always be brought to room temperature prior to infusion.

Shelf life after removing the protective overwrap and after mixing of the contents of the bag:

Chemical and physical in-use stability after mixing the contents has been demonstrated for 7 days at 2 - 8 °C. After removing this bag from the refrigerator it is stable for 48 hours at 25 °C.

Shelf life after admixture of compatible additives:

From a microbiological point of view, the product should be used immediately after admixture of additives. If not used immediately after admixture of additives, in-use storage times and conditions prior to use are the responsibility of the user.

The emulsion is to be used immediately after opening of the container. Nutriflex Omega plus may only be mixed with other medicinal products for which compatibility has been documented. Compatibility data for different additives (e.g. electrolytes, trace elements, vitamins) and the corresponding shelf life of such admixtures can be provided on demand by the manufacturer.


B. Braun Melsungen AG

34209 Melsungen Germany

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