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NUTRIFLEX OMEGA 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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170/12609620/0815

Package leaflet: Information for the user

Nutriflex® Omega plus
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

If you use more Nutriflex® Omega plus than you should

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

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 imme­
diately.

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 (ACEinhibitors 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.

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.

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 www.mhra.gov.uk/yellowcard.
Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2;
Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie;
e-mail: medsafety@hpra.ie
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)

in
1000 ml

in
1250 ml

in
in
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

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

in
1000 ml

in
1250 ml

in
in
1875 ml 2500 ml

Medium-chain
triglycerides

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

Omega-3-acid
triglycerides

4.000 g

5.000 g

7.500 g

10.00 g

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schwarz
Format = 210 x 594 mm
2 Seiten
Lätus 1398

GB-IE___170
Nutriflex® Omega plus
170/12609620/0815
GIF – 3KB
Standort Melsungen

Font size: 9,5 pt.

G 121712

170/12609620/0815

from the lower
chamber (amino
acid solution)

in
1000 ml

in
1250 ml

in
in
1875 ml 2500 ml

Isoleucine

2.256 g

2.820 g

4.230 g

5.640 g

Leucine

3.008 g

3.760 g

5.640 g

7.520 g

Lysine hydrochloride
equivalent to lysine

2.728 g
2.184 g

3.410 g
2.729 g

5.115 g
4.094 g

6.820 g
5.459 g

Methionine

1.880 g

2.350 g

3.525 g

4.700 g

Phenylalanine

3.368 g

4.210 g

6.315 g

8.420 g

Threonine

1.744 g

2.180 g

3.270 g

4.360 g

Tryptophan

0.544 g

0.680 g

1.020 g

1.360 g

Valine

2.496 g

3.120 g

4.680 g

6.240 g

Arginine

2.592 g

3.240 g

4.860 g

6.480 g

Histidine hydro­
chloride monohydrate
equivalent to
­histidine

1.624 g

2.030 g

3.045 g

4.060 g

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

Glycine

1.584 g

1.980 g

2.970 g

3.960 g

Proline

3.264 g

4.080 g

6.120 g

8.160 g

Serine

2.880 g

3.600 g

5.400 g

7.200 g

Alanine

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

Electrolytes

in
1000 ml

in
1250 ml

in
1875 ml

in
2500 ml

Sodium

40 mmol

50 mmol

75 mmol

100 mmol

Potassium

28 mmol

35 mmol 52.5 mmol

70 mmol

Magnesium

3.2 mmol

4.0 mmol

6.0 mmol

8.0 mmol

Calcium

3.2 mmol

4.0 mmol

6.0 mmol

8.0 mmol

Zinc

0.024 mmol 0.03 mmol 0.045 mmol 0.06 mmol

Chloride

36 mmol

45 mmol

67.5 mmol

90 mmol

Acetate

36 mmol

45 mmol

67.5 mmol

90 mmol

Phosphate

12 mmol

15 mmol 22.5 mmol

30 mmol

Amino acid
content

38 g

48 g

72 g

96 g

Nitrogen
content

5.4 g

6.8 g

10.2 g

13.6 g

Carbohydrate
content

120 g

150 g

225 g

300 g

Lipid content

40 g

50 g

75 g

100 g

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
5020 kJ
(900 kcal) (1200 kcal)

Energy in the
form of amino
acids

635 kJ
(150 kcal)

800 kJ
(190 kcal)

1200 kJ
(285 kcal)

Non-protein
energy

3600 kJ
4500 kJ
6750 kJ
9000 kJ
(860 kcal) (1075 kcal) (1615 kcal) (2155 kcal)

Total energy

4235 kJ
5300 kJ
7950 kJ 10600 kJ
(1010 kcal) (1265 kcal) (1900 kcal) (2530 kcal)

1600 kJ
(380 kcal)

Osmolality

1540
mOsm/kg

1540
mOsm/kg

1540
mOsm/kg

1540
mOsm/kg

Theoretical
osmolarity

1215
mOsm/l

1215
mOsm/l

1215
mOsm/l

1215
mOsm/l

5.0 - 6.0

5.0 - 6.0

5.0 - 6.0

5.0 - 6.0

pH

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

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-Straße 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

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.
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

12609620_NutriflexOmega plus_GIF-3KB_210x594__GB-IE_170.indd 2

B. Braun Melsungen AG
34209 Melsungen
Germany

11.08.15 06:34

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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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