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NUTRIFLEX OMEGA SPECIAL 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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179/12609625/0815

Package leaflet: Information for the user

Nutriflex® Omega special
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

Use in children and adolescents

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

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.

1. What Nutriflex® Omega special is and what it is used
for
Nutriflex® Omega special 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 special 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
Do not use Nutriflex® Omega special
• if you are allergic to egg, peanut, fish or soybean 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 special 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 special.
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 special 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 special
Tell your doctor if you are taking, have recently taken or might take
any other medicines.
Nutriflex® Omega special 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 special
in pregnant women.
Breast-feeding is not recommended for mothers on parenteral nutrition.

Driving and using machines
Nutriflex® Omega special 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 special
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.

If you use more Nutriflex® Omega special 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.

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 special 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 special
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 special contains
The active substances in the ready-for-use-mixture are:
from the
in
in
in
in
in
­upper,
1000 ml
625 ml 1250 ml 1875 ml 2500 ml
left-hand
chamber
(glucose solution)
158.4 g 99.00 g 198.0 g
297.0 g 396.0 g
Glucose
monohydrate
144.0 g 90.00 g 180.0 g 270.0 g 360.0 g
equivalent
to anhydrous
glucose
2.496 g 1.560 g
3.120 g 4.680 g 6.240 g
Sodium
­dihydrogen
phosphate
dihydrate
Zinc acetate
7.024 mg 4.390 mg 8.780 mg 13.17 mg 17.56 mg
dihydrate

B|BRAUN
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11.08.15 06:38

schwarz
Format = 210 x 594 mm
2 Seiten
Lätus 1399

GB-IE___179
Nutriflex® Omega special
179/12609625/0815
GIF – 3KB
Standort Melsungen
Font size: 9,5 pt.

G 121712

179/12609625/0815

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

from the
upper, righthand chamber
(fat emulsion)
Medium-chain
triglycerides
Soya-bean oil,
refined

in
1000 ml

in
625 ml

in
1250 ml

in
1875 ml

in
2500 ml

20.00 g

12.50 g

25.00 g

37.50 g

50.00 g

16.00 g

10.00 g

20.00 g

30.00 g

40.00 g

Omega-3-acid
triglycerides

4.000 g

2.500 g

5.000 g

7.500 g

10.00 g

from the
lower chamber (amino
acid solution)

in
1000 ml

in
625 ml

in
1250 ml

in
1875 ml

in
2500 ml

Isoleucine

3.284 g

2.053 g

4.105 g

6.158 g

8.210 g

Leucine

4.384 g

2.740 g

5.480 g

8.220 g

10.96 g

Lysine hydrochloride
equivalent to
lysine

3.980 g

2.488 g

4.975 g

7.463 g

9.950 g

3.186 g

1.991 g

3.982 g

5.973 g

7.962 g

Methionine

2.736 g

1.710 g

3.420 g

5.130 g

6.840 g

Phenylalanine

4.916 g

3.073 g

6.145 g

9.218 g

12.29 g

Threonine

2.540 g

1.588 g

3.175 g

4.763 g

6.350 g

Not all pack sizes may be marketed.

Tryptophan

0.800 g

0.500 g

1.000 g

1.500 g

2.000 g

Marketing Authorisation Holder and Manufacturer

Valine

3.604 g

2.253 g

4.505 g

6.758 g

9.010 g

Arginine

3.780 g

2.363 g

4.725 g

7.088 g

9.450 g

Histidine hydrochloride
monohydrate
equivalent to
histidine

2.368 g

1.480 g

2.960 g

4.440 g

5.920 g

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

1.753 g

1.095 g

2.191 g

3.286 g

4.381 g

Alanine

6.792 g

4.245 g

8.490 g

12.73 g

16.98 g

Aspartic acid

2.100 g

1.313 g

2.625 g

3.938 g

5.250 g

Glutamic acid

4.908 g

3.068 g

6.135 g

9.203 g

12.27 g

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 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)
• 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 625 ml, 5 x 1250 ml, 5 x 1875 ml and 5 x 2500 ml

Postal address:
34209 Melsungen, Germany

This medicinal product is authorised in the Member States of
the EEA under the following names:
Austria
Belgium
Bulgaria
Cyprus
Czech Republic
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Ireland
Italy
Latvia
Lithuania
Luxembourg
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom

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Glycine

2.312 g

1.445 g

2.890 g

4.335 g

5.780 g

Proline

4.760 g

2.975 g

5.950 g

8.925 g

11.90 g

Serine

4.200 g

2.625 g

5.250 g

7.875 g

10.50 g

Sodium
­hydroxide

1.171 g

0.732 g

1.464 g

2.196 g

2.928 g

Sodium
­chloride

0.378 g

0.237 g

0.473 g

0.710 g

0.946 g

Sodium
­acetate
­trihydrate

0.250 g

0.157 g

0.313 g

0.470 g

0.626 g

Potassium
acetate

3.689 g

2.306 g

4.611 g

6.917 g

9.222 g

Magnesium acetate
­tetrahydrate

0.910 g

0.569 g

1.137 g

1.706 g

2.274 g

Calcium
­chloride
­dihydrate

0.623 g

0.390 g

0.779 g

1.169 g

1.558 g

Electrolytes

in
1000 ml

in
625 ml

in
1250 ml

in
1875 ml

in
2500 ml

Sodium

53.6
mmol

33.5
mmol

67
mmol

100.5
mmol

134
mmol

Potassium

37.6
mmol

23.5
mmol

47
mmol

70.5
mmol

94
mmol

Magnesium

4.2
mmol

2.65
mmol

5.3
mmol

7.95
mmol

10.6
mmol

The following information is intended for healthcare professionals only:

Calcium

4.2
mmol

2.65
mmol

5.3
mmol

7.95
mmol

10.6
mmol

Zinc

0.03
mmol

0.02
mmol

0.04
mmol

0.06
mmol

0.08
mmol

Nutriflex® Omega special 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.

Chloride

48 mmol 30 mmol 60 mmol 90 mmol 120 mmol

Acetate

48 mmol 30 mmol 60 mmol 90 mmol 120 mmol

Phosphate

16 mmol 10 mmol 20 mmol 30 mmol 40 mmol

Amino acid
content

56.0 g

35.1 g

70.1 g

105.1 g

140.1 g

8g

5g

10 g

15 g

20 g

Carbohydrate
content

144 g

90 g

180 g

270 g

360 g

Lipid content

40 g

25 g

50 g

75 g

100 g

Nitrogen
­content

This leaflet was last revised in July 2015

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:

Energy in the
form of lipid
Energy in
the form of
­carbohydrate

1590 kJ
995 kJ 1990 kJ 2985 kJ 3980 kJ
(380 kcal) (240 kcal) (475 kcal) (715 kcal) (950 kcal)
2415 kJ
(575
kcal)

1510 kJ
(360
kcal)

3015 kJ
(720
kcal)

4520 kJ
(1080
kcal)

6030 kJ
(1440
kcal)

Energy in the
940 kJ
590 kJ 1170 kJ 1755 kJ 2340 kJ
form of amino (225 kcal) (140 kcal) (280 kcal) (420 kcal) (560 kcal)
acids
Non-protein
energy

4005 kJ
(955
kcal)

2505 kJ
(600
kcal)

5005 kJ
(1195
kcal)

7510 kJ 10010 kJ
(1795
(2390
kcal)
kcal)

Total energy

4945 kJ
(1180
kcal)

3095 kJ
(740
kcal)

6175 kJ
(1475
kcal)

9265 kJ 12350 kJ
(2215
(2950
kcal)
kcal)

Osmolality
Theoretical
osmolarity
pH

2115
2115
2115
2115
2115
mOsm/kg mOsm/kg mOsm/kg mOsm/kg mOsm/kg
1545
mOsm/l

1545
mOsm/l

1545
mOsm/l

1545
mOsm/l

1545
mOsm/l

5.0 - 6.0 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-α-tocopherol, sodium hydroxide for pH
adjustment and water for injections.

• 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 special 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

12609625_NutriflexOmega special_GIF-3KB_210x594__GB-IE_179.indd 2

B. Braun Melsungen AG
34209 Melsungen
Germany

11.08.15 06:38

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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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