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OMEFLEX PLUS EMULSION FOR INFUSION

Active substance(s): ALANINE / ARGININE / ASPARTIC ACID / CALCIUM CHLORIDE DIHYDRATE / GLUCOSE MONOHYDRATE / GLUTAMIC ACID / GLYCINE / HISTIDINE HYDROCHLORIDE MONOHYDRATE / ISOLEUCINE / LEUCINE / LYSINE HYDROCHLORIDE / MAGNESIUM ACETATE TETRAHYDRATE / MEDIUM CHAIN TRIGLYCERIDES / METHIONI

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170/12619803/0617

Package leaflet: Information for the user
B. Braun Melsungen AG · 34209 Melsungen, Germany

Nutriflex Omega 38/120/40
emulsion for infusion
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.

What is in this leaflet
1. What Nutriflex Omega 38/120/40 is and what it is used for
2. What you need to know before you use Nutriflex Omega 38/120/40
3. How to use Nutriflex Omega 38/120/40
4. Possible side effects
5. How to store Nutriflex Omega 38/120/40
6. Contents of the pack and other information

1. What Nutriflex Omega 38/120/40 is and what it is
used for
Nutriflex Omega 38/120/40 contains fluids and 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.
Nutriflex Omega 38/120/40 is given to adults.
You are given Nutriflex Omega 38/120/40 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 38/120/40
Do not use Nutriflex Omega 38/120/40
• if you are allergic to any of the active substances, to egg, peanut,
soybean or fish or to 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 38/120/40 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 (severe
coagulopathy, aggravating haemorrhagic diatheses)
• blocking of blood vessels by blood clots or fat (embolism)
• severe liver failure
• impaired bile flow (intrahepatic cholestasis)
• severe kidney failure in the absence of kidney replacement therapy
• 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, pharmacist or nurse before using Nutriflex Omega
38/120/40 .
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 or your acid-base balance
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.
Your healthcare professional will also take measures to ensure that your
body’s fluid and electrolyte requirements are met. In addition to Nutriflex
Omega 38/120/40 you will receive further nutrients (foodstuffs) in order
to fully cover your requirements.

• 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 or 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 (leucopenia)
• 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.
If you have any further questions on the use of this medicine, ask your
doctor, pharmacist or nurse.

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 (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):
• feeling sick, vomiting, loss of appetite
Rare (may affect up to 1 in 1,000 people):
• 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 (may affect up to 1 in 10,000 people):
• 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
38/120/40 than you should” in section 3. Symptoms normally disappear
when the infusion is stopped.
Not known (frequency cannot be estimated from the available data):
• reduction of white blood cell count (leucopenia)
• reduction of blood platelet count (thrombocytopenia)
• impaired bile flow (cholestasis)

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 leaflet.
You can also report side effects directly via the national reporting system
listed in Appendix V. By reporting side effects you can help provide more
information on the safety of this medicine.

Children

5. How to store Nutriflex Omega 38/120/40

The safety and efficacy in children over 2 years have not been established
yet. No data are available.
This medicine must not be given to newborn infants, infants and toddlers
under two years old.

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 which is stated on the label.
The expiry date refers to the last date of that month.
Keep the bag in the protective overwrap in order to protect from light.

Other medicines and Nutriflex Omega 38/120/40
Tell your doctor, pharmacist or nurse if you are taking, have recently taken
or might take any other medicines.
Nutriflex Omega 38/120/40 can interact with some other medicines.
Please tell your doctor, pharmacist or nurse 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 ciclosporin 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 or pharmacist for advice before
taking this medicine. If you are pregnant you will receive this medicine
only if the doctor or pharmacist considers it absolutely necessary for your
recovery. There is no data available about the use of Nutriflex Omega
38/120/40 in pregnant women.
Breast-feeding is not recommended for mothers on parenteral nutrition.

Driving and using machines
This medicine is normally given to immobile patients, e.g. in a hospital
or clinic which would exclude driving or using machines. However, the
medicine itself has no effect on the ability to drive or use machines.

3. How to use Nutriflex Omega 38/120/40
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. The recommended duration
of infusion for a parenteral nutrition bag is maximum 24 h.
Your doctor or pharmacist will decide how much of this medicine you
need and for how long you will require treatment with this medicine.

Use in children
The safety and efficacy in children over 2 years have not been established
yet. No data are available.
This medicine must not be given to newborn infants, infants and toddlers
under two years old.

If you use more Nutriflex Omega 38/120/40 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

6. Contents of the pack and other information
What Nutriflex Omega 38/120/40 contains
The active substances in the ready-for-use mixture are:
from the top chamber
in 1000 ml in 1250 ml in 1875 ml
(glucose solution)
Glucose monohydrate
132.0 g 165.0 g 247.5 g
equivalent to glucose
120.0 g 150.0 g 225.0 g
Sodium dihydrogen
phosphate dihydrate
1.872 g 2.340 g 3.510 g
Zinc acetate dihydrate
5.264 mg 6.580 mg 9.870 mg
from the middle chamber
(fat emulsion)
in 1000 ml in 1250 ml in 1875 ml
Medium-chain triglycerides
20.00 g 25.00 g 37.50 g
Soya-bean oil, refined
16.00 g 20.00 g 30.00 g
Omega-3-acid triglycerides
4.000 g 5.000 g 7.500 g
from the bottom chamber
in 1000 ml in 1250 ml in 1875 ml
(amino acid solution)
Isoleucine
2.256 g 2.820 g 4.230 g
Leucine
3.008 g 3.760 g 5.640 g
Lysine hydrochloride
2.728 g 3.410 g 5.115 g
equivalent to lysine
2.184 g 2.729 g 4.094 g
Methionine
1.880 g 2.350 g 3.525 g
Phenylalanine
3.368 g 4.210 g 6.315 g
Threonine
1.744 g 2.180 g 3.270 g
Tryptophan
0.544 g 0.680 g 1.020 g
Valine
2.496 g 3.120 g 4.680 g
Arginine
2.592 g 3.240 g 4.860 g
Histidine hydrochloride
monohydrate
1.624 g 2.030 g 3.045 g
equivalent to histidine
1.202 g 1.503 g 2.254 g
Alanine
4.656 g 5.820 g 8.730 g
Aspartic acid
1.440 g 1.800 g 2.700 g
Glutamic acid
3.368 g 4.210 g 6.315 g
Glycine
1.584 g 1.980 g 2.970 g
Proline
3.264 g 4.080 g 6.120 g
Serine
2.880 g 3.600 g 5.400 g
Sodium hydroxide
0.781 g 0.976 g 1.464 g
Sodium chloride
0.402 g 0.503 g 0.755 g
Sodium acetate trihydrate
0.222 g 0.277 g 0.416 g
Potassium acetate
2.747 g 3.434 g 5.151 g
Magnesium acetate
tetrahydrate
0.686 g 0.858 g 1.287 g
Calcium chloride dihydrate
0.470 g 0.588 g 0.882 g
in 1000 ml in 1250 ml in 1875 ml
Amino acid content [g]
38
48
72
Nitrogen content [g]
5.4
6.8
10.2
Carbohydrate content [g]
120
150
225
Lipid content [g]
40
50
75

in 2500 ml
330.0 g
300.0 g
4.680 g
13.16 mg
in 2500 ml
50.00 g
40.00 g
10.00 g
in 2500 ml
5.640 g
7.520 g
6.820 g
5.459 g
4.700 g
8.420 g
4.360 g
1.360 g
6.240 g
6.480 g
4.060 g
3.005 g
11.64 g
3.600 g
8.420 g
3.960 g
8.160 g
7.200 g
1.952 g
1.006 g
0.554 g
6.868 g
1.716 g
1.176 g
in 2500 ml
96
13.7
300
100

B|BRAUN
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07.06.17 16:55

schwarz (10% – 100%)
Format = 210 x 594 mm
2 Seiten
Lätus 8696

MRP___170 - LIFE N
170/12619803/0617
GIF
Production site: Melsungen (LIFE N)

Font size: 9,0 pt.

170/12619803/0617

Electrolytes [mmol]
Sodium
Potassium
Magnesium
Calcium
Zinc
Chloride
Acetate
Phosphate

in 1000 ml in 1250 ml in 1875 ml in 2500 ml
40
50
75
100
28
35
52.5
70
3.2
4.0
6.0
8.0
3.2
4.0
6.0
8.0
0.024
0.03
0.045
0.06
36
45
67.5
90
36
45
67.5
90
12
15
22.5
30
in 1000 ml in 1250 ml in 1875 ml in 2500 ml
Energy in the form
1590
1990
2985
3980
of lipids [kJ (kcal)]
(380)
(475)
(715)
(950)
Energy in the form of
2010
2510
3765
5020
carbohydrates [kJ (kcal)]
(480)
(600)
(900)
(1200)
Energy in the form of
635
800
1200
1600
amino acids [kJ (kcal)]
(150)
(190)
(285)
(380)
Non-protein energy
3600
4500
6750
9000
[kJ (kcal)]
(860)
(1075)
(1615)
(2155)
Total energy
4235
5300
7950
10600
[kJ (kcal)]
(1010)
(1265)
(1900)
(2530)
Osmolality [mOsm/kg]
1540
Theoretical osmolarity [mOsm/l]
1215
pH
5.0 - 6.0
The other ingredients are citric acid monohydrate (for pH adjustment),
egg lecithin, glycerol, sodium oleate, all-rac-alpha-tocopherol, sodium
hydroxide (for pH adjustment) and water for injections.

What Nutriflex Omega 38/120/40 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 38/120/40 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)
Tear Notches

Handle Hanger

Overwrap

Glucose
Fat
Emulsion
Amino Acid
Solution

Figure A: The multichamber bag is packed in a protective overwrap. An
oxygen absorber and an oxygen indicator are placed between the bag and
the overwrap; the oxygen absorber sachet is made of inert material and
contains iron hydroxide.
Figure B: The top chamber contains a glucose solution, the middle
chamber contains a fat emulsion, and the bottom chamber contains an
amino acid solution.
The glucose and the amino acid solutions are clear and colourless up to
straw-coloured. The fat emulsion is milky-white.
The top chamber and the middle chamber can be connected with the
bottom chamber by opening the intermediate seams.
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-Straße 1
34212 Melsungen, Germany
Phone: +49-5661-71-0
Fax: +49-5661-71-4567

Postal address:
34209 Melsungen, Germany

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

Bulgaria
Croatia
Czech Republic
Denmark
Finland
France
Germany
Greece
Ireland
Italy
Luxembourg
Netherlands
Norway
Portugal
Romania
Slovakia
Spain
Sweden
United Kingdom

NuTRIflex Omega plus B.Braun
Nutriflex Omega plus 38 g/l AA 120 g/l G, émulsion
pour perfusion / emulsie voor infusie / Emulsion zur
Infusion
Nutriflex Omega 38/120 emulsion for infusion
Nutriflex Omega 38/120 plus emulzija infuziju
Nutriflex Omega plus 38/120
Nutriflex Omega Plus
Nutriflex Omega 38/120/40
LIPOFLEX OMEGA G120/N5,4/E, émulsion pour
perfusion
NuTRIflex Omega plus novo
Nutriflex Omega 38/120 plus
Omeflex plus emulsion for infusion
Omegaflex AA38/G120 emulsione per infusione
NuTRIflex Omega plus novo
Nutriflex Omega plus, 38 g/l + 120 g/l, emulsie voor
infusie
Nutriflex Omega PlusPoland Omegaflex plus
Omegaflex plus emulsão para perfusão
Omegaflex plus emulsie perfuzabilă
Nutriflex Omega plus 38/120
Nutriflex Omega 38/120 plus emulsión para perfusión
Nutriflex Omega 38/120/40
Omeflex plus emulsion for infusion

This leaflet was last revised in April 2017
Oxygen Indicator

Figure A

Oxygen Absorber

Infusion Port

Medication Port

Figure B

The following information is intended for healthcare professionals only:
No special requirements for disposal.
Parenteral nutrition products should be visually inspected for damage, discolouration and emulsion instability before use.
Do not use bags which are damaged. Overwrap, primary bag and the peel seam between the chambers should be intact. Only use if the amino acid and
glucose solutions are clear and colourless up to straw coloured and the lipid emulsion is homogenous with milky white appearance. Do not use if the
solutions contain particulate matter.
After mixing the three chambers, do not use if the emulsion shows discoloration or signs of phase separation (oil drops, oil layer). Stop the infusion
immediately in case of discoloration of the emulsion 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 mixed emulsion
Strict adherence to aseptic handling principles must be complied with.
To open: Tear overwrap starting from the tear notches (Fig. 1). Remove the bag from its protective overwrap. Discard overwrap, oxygen indicator and
oxygen absorber.
Visually inspect the primary bag for leaks. Leaky bags must be discarded, since the sterility cannot be guaranteed.

2a

1

2b

3

To open and mix the chambers sequentially, roll the bag with both hands, starting first by opening the peel seam that separates the top chamber
(glucose) and the bottom chamber (amino acids) (Fig. 2a). Then continue applying pressure so that the peel seam separating the middle chamber (lipids)
and the bottom chamber opens (Fig. 2b).
Addition of additives
After removing the aluminium seal (Fig. 3) one can add compatible additives via the medication port (Fig. 4).
Nutriflex Omega 38/120/40 can be mixed with the following additives up to the below specified upper concentration limits or maximum amount of
additives after supplementation. The resulting admixtures are stable for 7 days between +2 °C to +8 °C plus 2 days at 25 °C.
- Electrolytes: take account of the electrolytes already present in the bag; stability has been demonstrated up to a total quantity 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.
- Alanyl-Glutamin up to 24 g/l.
- Trace elements and vitamins: stability has been demonstrated with commercially available multi-trace elements and multi-vitamins (e.g. Tracutil,
Cernevit) up to the standard dosage recommended by the respective manufacturer of the micronutrient formulation.
Detailed information about the above mentioned additives and the corresponding shelf life of such admixtures can be provided on demand by the
manufacturer.

4

5

6

Mix the contents of the bag thoroughly (Fig. 5) and visually inspect the mixture (Fig. 6). There should be no signs of emulsion phase separation.
The mixture is a milky-white homogenous oil-in-water emulsion.
Preparation for infusion
The emulsion should always be brought to room temperature prior to infusion.
Remove the aluminium foil from the infusion port (Fig. 7) and attach the infusion set (Fig. 8). Use a non-vented infusion set or close the air vent when
using a vented set. Hang the bag on an infusion stand (Fig. 9) and carry out infusion using the standard technique.

7

8

9

For single use only. Container and unused residues must be discarded after use.
Do not reconnect partially used containers.
If filters are used they must be lipid-permeable (pore size ≥ 1.2 μm).
Shelf life after removing the protective overwrap and after mixing of the contents of the bag
Chemical and physicochemical in-use stability of the mixture of amino acids, glucose and fat was demonstrated for 7 days at 2-8 °C and additional
2 days 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.
After first opening (spiking of the infusion port)
The emulsion is to be used immediately after opening of the container.
Nutriflex Omega 38/120/40 must not be mixed with other medicinal products for which compatibility has not been documented.
Nutriflex Omega 38/120/40 should not be given simultaneously with blood in the same infusion set due to the risk of pseudoagglutination.

B|BRAUN
12619803_Nutriflex Omega 38-120-40_GIF-210x594__MRP.indd 2

B. Braun Melsungen AG
34209 Melsungen, Germany

07.06.17 16:55

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