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NUTRIFLEX LIPID SPECIAL WITHOUT ELECTROLYTES EMULSION FOR INFUSION

Active substance(s): ALANINE / ARGININE / ASPARTIC ACID / GLUCOSE MONOHYDRATE / GLUTAMIC ACID / GLYCINE / HISTIDINE / ISOLEUCINE / LEUCINE / LYSINE HYDRATE / MEDIUM CHAIN TRIGLYCERIDES / METHIONINE / PHENYLALANINE / PROLINE / SERINE / SOYA OIL / THREONINE / TRYPTOPHAN / VALINE

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

NuTRIflex® Lipid special without electrolytes
Emulsion for Infusion

Read all of this leaflet carefully 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 Lipid special without electrolytes is and what it is
used for
2. What you need to know before you use NuTRIflex Lipid special without
electrolytes
3. How to use NuTRIflex Lipid special without electrolytes
4. Possible side effects
5. How to store NuTRIflex Lipid special without electrolytes
6. Contents of the pack and other information

1. What NuTRIflex Lipid special without electrolytes is
and what it is used for
NuTRIflex Lipid special without electrolytes contains 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.
You are given NuTRIflex Lipid special without electrolytes 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
Lipid special without electrolytes
Do not use NuTRIflex Lipid special without electrolytes
• if you are allergic to egg, peanut or soybean 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 Lipid special without electrolytes 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 Lipid special without
electrolytes.
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
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
Lipid special without electrolytes you may receive further nutrients
(foodstuffs) in order to fully cover your requirements.

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

Other medicines and NuTRIflex Lipid special without electrolytes
Tell your doctor if you are taking, have recently taken or might take any
other medicines.
NuTRIflex Lipid special without electrolytes 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 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 Lipid special without
electrolytes in pregnant women.
Breast-feeding is not recommended for mothers on parenteral nutrition.

Driving and using machines
NuTRIflex Lipid special without electrolytes is normally given to
immobile patients in a hospital or clinic. This will exclude driving and
using machines.

NuTRIflex Lipid special without electrolytes contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per multichamber
bag, i.e. it is essentially ‘sodium-free’.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

3. How to use NuTRIflex Lipid special without electrolytes
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
This medicine must not be given to newborn infants, infants and toddlers
under two years old.

If you use more NuTRIflex Lipid special without electrolytes 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
• 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 Lipid
special without electrolytes than you should” in section 3. Symptoms
normally disappear when the infusion is stopped.
If you get any side effects, talk to your doctor or nurse. This includes any
possible side effects not listed in this leaflet.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly viathe national reporting system.
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store NuTRIflex Lipid special without
electrolytes
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.
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 Lipid special without electrolytes contains
The ready-for-use emulsion for intravenous infusion contains, in all
three sizes of the product:
from the larger
in 1250 ml in 1875 ml in 2500 ml
upper, left
Size 1
Size 2
Size 3
chamber (500,
750 and 1000 mL)
Glucose
198.0 g
297.0 g
396,0 g
monohydrate
equivalent to
180.0 g
270.0 g
360.0 g
anhydrous glucose

Quantity
per
1000 ml

from the smaller
upper, right
chamber (250,
375 and 500 ml)
Soya bean oil,
refined
Medium chain
triglycerides

Quantity
per
1000 ml

in 1250 ml in 1875 ml in 2500 ml
Size 1
Size 2
Size 3

158.4 g
144.0 g

25.0 g

37.5 g

50.0 g

20.0 g

25.0 g

37.5 g

50.0 g

20.0 g

from the lower
in 1250 ml in 1875 ml in 2500 ml
chamber (500,
Size 1
Size 2
Size 3
750 and 1000 mL)
Isoleucine
4.11 g
6.16 g
8.21 g
Leucine
5.48 g
8.22 g
10.96 g
Lysine
4.47 g
6.71 g
8.94 g
hydrochloride
equivalent to
3.98 g
5.97 g
7.96 g
Lysine
Methionine
3.42 g
5.13 g
6.84 g
Phenylalanine
6.15 g
9.22 g
12.29 g
Threonine
3.18 g
4.76 g
6.35 g
Tryptophan
1.00 g
1.50 g
2.00 g
Valine
4.51 g
6.76 g
9.01 g
Arginine
4.73 g
7.09 g
9.45 g
Histidine hydro2.19 g
3.29 g
4.38 g
chloride monohydrate equivalent to
Histidine

Quantity
per
1000 ml
3.28 g
4.38 g
3.58 g

B|BRAUN

3.18 g
2.74 g
4.92 g
2.54 g
0.80 g
3.60 g
3.78 g
1.75 g

121715

174/12262552/0314

Alanine
Aspartic acid
Glutamic acid
Glycine
Proline
Serine

Amino acid
content
Nitrogen
content
Carbohydrate
content
Lipid content

8.49 g
2.63 g
6.14 g
2.89 g
5.95 g
5.25 g

[g]

12.73 g
3.94 g
9.20 g
4.33 g
8.93 g
7.88 g

16.98 g
5.25 g
12.27 g
5.78 g
11.90 g
10.50 g

6.79 g
2.10 g
4.91 g
2.31 g
4.76 g
4.20 g

in 1250 ml in 1875 ml in 2500 ml
Size 1
Size 2
Size 3
70.1

105.1

140.1

Quantity
per
1000 ml
56.0

10

15

20

8

180

270

360

144

50

75

100

40

[g]
[g]
[g]

For the full list of excipients, see section 6.1.
The other ingredients are citric acid monohydrate, egg lecithin, glycerol,
sodium oleate and water for injections.

What NuTRIflex Lipid special without electrolytes 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 Lipid special without electrolytes 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 or
faintly 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.

The following information is intended for healthcare professionals only:
NuTRIflex Lipid special without electrolytes 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 faintly 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 accidentally frozen, discard the bag.
If filters are used they must be lipid-permeable.
Preparation of the mixed emulsion:
Remove the 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 plus 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 Lipid special without electrolytes must not be used as a carrier
solution for pharmaceuticals or be mixed with other infusion solutions
without testing, since it is not possible to guarantee adequate stability of
the emulsion. 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.

Marketing Authorisation Holder and Manufacturer:
B. Braun Melsungen AG
Carl-Braun-Str. 1
34212 Melsungen, Germany
Tel.: +49-(0)-5661-71-0
Fax: +49-(0)-5661-71-4567

Postal address:
34209 Melsungen, Germany

This leaflet was last revised in 02/2014

B|BRAUN

B. Braun Melsungen AG
34209 Melsungen, Germany

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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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