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OMEFLEX SPECIAL WITHOUT ELECTROLYTES EMULSION FOR INFUSION

Active substance(s): ALANINE / ARGININE / ASPARTIC ACID / GLUCOSE MONOHYDRATE / GLUTAMIC ACID / GLYCINE / HISTIDINE / ISOLEUCINE / LEUCINE / LYSINE MONOHYDRATE / MEDIUM-CHAIN TRIGLYCERIDES NEUTRAL / METHIONINE / OMEGA-3-ACID TRIGLYCERIDES / PHENYLALANINE / PROLINE / SERINE / SOYA-BEAN OIL RE

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740/12619320/0617

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

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

1. What Nutriflex Omega special elektrolytfri is and what it
is used for
Nutriflex Omega special elektrolytfri contains fluids and substances called
amino acids 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 special elektrolytfri is given to adults.
You are given Nutriflex Omega special elektrolytfri 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
special elektrolytfri
Do not use Nutriflex Omega special elektrolytfri
• 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 special elektrolytfri 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
special elektrolytfri.
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.
This medicine is an electrolyte free solution. Your healthcare professional
will take measures to ensure that your body’s fluid and electrolyte
requirements are met. In addition to this medicine you will receive further
nutrients (foodstuffs) in order to fully cover your requirements.

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.

Other medicines and Nutriflex Omega special elektrolytfri
Tell your doctor, pharmacist or nurse if you are taking, have recently taken
or might take any other medicines.
Nutriflex Omega special elektrolytfri 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

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
special elektrolytfri 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.

Nutriflex Omega special elektrolytfri contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per multichamber
bag, i.e. it is essentially ‘sodium-free’.

3. How to use Nutriflex Omega special elektrolytfri
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 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 yet been
established. 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 special elektrolytfri than you
should

schwarz (10% - 100%)

• 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 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
special elektrolytfri 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 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.

5. How to store Nutriflex Omega special elektrolytfri
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.
Keep the bag in the protective overwrap in order to protect from light.
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.

6. Contents of the pack and other information
What Nutriflex Omega special elektrolytfri contains
The active substances in the ready-for-use mixture are:
from the top chamber
(glucose solution)
in 1000 ml in 625 ml in 1250 ml in 1875 ml
Glucose monohydrate
158.4 g 99.00 g 198.0 g 297.0 g
equivalent to glucose
144.0 g 90.00 g 180.0 g 270.0 g
from the middle chamber
(fat emulsion)
in 1000 ml in 625 ml in 1250 ml in 1875 ml
Medium-chain triglycerides
20.00 g 12.50 g 25.00 g 37.50 g
Soya-bean oil, refined
16.00 g 10.00 g 20.00 g 30.00 g
Omega-3-acid triglycerides
4.000 g 2.500 g 5.000 g 7.500 g
from the bottom chamber
(amino acid solution)
in 1000 ml in 625 ml in 1250 ml in 1875 ml
Isoleucine
3.284 g 2.053 g 4.105 g 6.158 g
Leucine
4.384 g 2.740 g 5.480 g 8.220 g
Lysine monohydrate
3.576 g 2.235 g 4.470 g 6.705 g
equivalent to lysine
3.184 g 1.990 g 3.979 g 5.969 g
Methionine
2.736 g
1.710 g 3.420 g 5.130 g
Phenylalanine
4.916 g
3.073 g 6.145 g 9.218 g
Threonine
2.540 g 1.588 g 3.175 g 4.763 g
Tryptophan
0.800 g 0.500 g 1.000 g 1.500 g
Valine
3.604 g 2.253 g 4.505 g 6.758 g
Arginine
3.780 g 2.363 g 4.725 g 7.088 g
Histidine
1.752 g 1.095 g 2.190 g 3.285 g
Alanine
6.792 g 4.245 g 8.490 g 12.73 g
Aspartic acid
2.100 g 1.313 g 2.625 g 3.938 g
Glutamic acid
4.908 g 3.068 g 6.135 g 9.203 g
Glycine
2.312 g 1.445 g 2.890 g 4.335 g
Proline
4.760 g 2.975 g 5.950 g 8.925 g
Serine
4.200 g 2.625 g 5.250 g 7.875 g
Amino acid content [g]
Nitrogen content [g]
Carbohydrate content [g]
Lipid content [g]

in 1000 ml
56.0
8
144
40

in 625 ml in 1250 ml in 1875 ml
35.0
70.1
105.1
5
10
15
90
180
270
25
50
75

If you have received too much of this medicine, you may suffer from a socalled ‘overload syndrome’ and the following symptoms:

B|BRAUN
12619320_Nutriflex Omega special woE_GIF-210x594__MRP.indd 1

07.06.17 16:54

Format = 210 x 594 mm
2 Seiten
Lätus 8695

MRP___740-LIFE N
740/12619320/0617
GIF
Production site: Melsungen (LIFE N)

Font size: 9,0 pt.

740/12619320/0617

in 625 ml in 1250 ml in 1875 ml
995
1990
2985
(240)
(475)
(715)
1510
3015
4520
(360)
(720)
(1080)
585
1170
1755
(140)
(280)
(420)
2505
5005
7510
(600)
(1195)
(1795)
Total energy [kJ (kcal)]
3090
6175
9265
(740)
(1475)
(2215)
Osmolality [mOsm/kg]
1840
Theoretical osmolarity [mOsm/l]
1330
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.

B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen, Germany
Phone: +49-5661-71-0
Fax: +49-5661-71-4567

What Nutriflex Omega special elektrolytfri looks like and contents
of the pack

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

The ready-to-use product is an emulsion for infusion, i.e. it is administered
through a small tube into a vein.
Nutriflex Omega special elektrolytfri is supplied in flexible multichamber
bags containing:
• 625 ml (250 ml of amino acids solution + 125 ml of fat emulsion
+ 250 ml of glucose solution)
• 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)

Austria
Belgium

Energy in the form
of lipids [kJ (kcal)]
Energy in the form
of carbohydrates [kJ (kcal)]
Energy in the form
of amino acids [kJ (kcal)]
Non-protein energy [kJ (kcal)]

Tear Notches

in 1000 ml
1590
(380)
2415
(575)
940
(225)
4005
(955)
4945
(1180)

Handle Hanger

Overwrap

Glucose
Fat
Emulsion
Amino Acid
Solution

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 625 ml, 5 x 1250 ml, and 5 x 1875 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

NuTRIflex Omega special ohne Elektrolyte B.Braun
Nutriflex Omega special EF, 56 g/l AA + 144 g/l G,
emulsie voor infusie, émulsion pour perfusion,
Emulsion zur Infusion
Nutriflex Omega special bez elektrolytů
Nutriflex Omega Special elektrolytfri
LIPOFLEX OMEGA G144/N8, émulsion pour perfusion
NuTRIflex Omega special ohne Elektrolyte novo
Nutriflex Omega special without electrolytes
Omeflex special without electrolytes emulsion for
infusion
Omegaflex AA38/G120 senza elettroliti
NuTRIflex Omega special ohne Elektrolyte novo
Nutriflex Omega special zonder elektrolyten,
56 g/l + 144 g/l, emulsie voor infusie
Nutriflex Omega Special elektrolytfri
Nutriflex Omega special without electrolytes
Nutriflex Omega special without electrolytes
emulsão para perfusão
Nutriflex Omega special bez elektrolytov
Nutriflex Omega special sin electrolitos Emulsión
para perfusión
Nutriflex Omega 56/144/40 elektrolytfri
Omeflex special without electrolytes emulsion for
infusion

Czech Republic
Denmark
France
Germany
Greece
Ireland
Italy
Luxembourg
Netherlands
Norway
Poland
Portugal
Slovakia
Spain

Oxygen Indicator

Oxygen Absorber

Infusion Port

Medication Port

Figure A
Figure B
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.

Postal address:
34209 Melsungen, Germany

Sweden
United Kingdom

This leaflet was last revised in April 2017

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 special elektrolytfri 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: 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 or up to a maximum concentration
of 30 mmol/l for organic phosphate (not both at the same time).
• 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 special elektrolytfri must not be mixed with other medicinal products for which compatibility has not been documented.
Nutriflex Omega special elektrolytfri should not be given simultaneously with blood in the same infusion set due to the risk of pseudoagglutination.

B|BRAUN
B. Braun Melsungen AG
34209 Melsungen, Germany

12619320_Nutriflex Omega special woE_GIF-210x594__MRP.indd 2

07.06.17 16:54

+ Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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