Nutriflex Lipid Special Emulsion For Infusion

173/12262544/0214

Package leaflet: Information for the user

B. Braun Melsungen AG • 34209 Melsungen, Germany

NuTRIflex® Lipid special

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 is and what it is used for

2. What you need to know before you use NuTRIflex Lipid special

3. How to use NuTRIflex Lipid special

4. Possible side effects

5. How to store NuTRIflex Lipid special

6. Contents of the pack and other information

1. What NuTRIflex Lipid special is and what it is used for

NuTRIflex Lipid 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 Lipid 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 Lipid special_

Do not use NuTRIflex Lipid special

• 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 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.

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 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

Tell your doctor if you are taking, have recently taken or might take any other medicines.

NuTRIflex Lipid 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 (ACE-inhibitors)

• medicines to treat high blood pressure or heart problems (angiotensin-ll-receptor antagonists)

• medicines used in organ transplants such as cyclosporine and tacrolimus

• medicines to treat inflammation (corticosteroids)

• hormonepreparationsthataffectyourfluidbalance(adrenocorticotropic hormone or 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.lf 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 in pregnant women.

Breast-feeding is not recommended for mothers on parenteral nutrition. Driving and using machines

NuTRIflex Lipid 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.

• 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 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 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.

S. How to store NuTRIflex Lipid 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.

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 contains

The active substances per individual chamber and respectively, per pack size, are:

from the larger upper, left chamber (500, 750 and 1000 mL)	in 1250 ml Size 1	in 1875 ml Size 2	in 2500 ml Size 3	Quantity per 1000 ml
Glucose monohydrate	198.0 g	297.0 g	396.0 g	158.4 g
equivalent to anhydrous glucose	180.0 g	270.0 g	360.0 g	144.0 g
Sodium dihydrogen phosphate dihydrate	3.120 g	4.680 g	6.240 g	2.496 g
Zinc acetate dihydrate	8.78 mg	13.17 mg	17.56 mg	7.02 mg

from the smaller upper, rightchamber (250, 375 and 500 ml)

in 1250 ml Size 1

in 1875 ml Size 2

in 2500 ml Size 3

Quantity per 1000 ml

Soya-bean oil, refined

25.0 g

37.5 g

50.0 g

20.0 g

Medium-chain

triglycerides

25.0 g

37.5 g

50.0 g

20.0 g

3. How to use NuTRIflex Lipid 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.

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 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

from the lower	in 1250 ml	in 1875 ml	in 2500 ml	Quantity
chamber (500, 750 and 1000 mL)	Size 1	Size 2	Size 3	per 1000 ml
Isoleucine	4.11 g	6.16 g	8.21 g	3.28 g
Leucine	5.48 g	8.22 g	10.96 g	4.38 g
Lysine hydrochloride	4.98 g	7.46 g	9.95 g	3.98 g
equivalent to lysine	3.98 g	5.96 g	7.95 g	3.18 g
Methionine	3.42 g	5.13 g	6.84 g	2.74 g
Phenylalanine	6.15 g	9.22 g	12.29 g	4.92 g
Threonine	3.18 g	4.76 g	6.35 g	2.54 g
Tryptophan	1.00 g	1.50 g	2.00 g	0.80 g
Valine	4.51 g	6.76 g	9.01 g	3.60 g
Arginine	4.73 g	7.09 g	9.45 g	3.78 g

B BRAUN

Histidine hydrochloride monohydrate equivalent to histidine	2.96 g 2.19 g	4.44 g 3.29 g	5.92 g 4.38 g	2.37 g 1.75 g
Alanine	8.49 g	12.73 g	16.98 g	6.79 g
Aspartic acid	2.63 g	3.94 g	5.25 g	2.10 g
Glutamic acid	6.14 g	9.20 g	12.27 g	4.91 g
Glycine	2.89 g	4.33 g	5.78 g	2.31 g
Proline	5.95 g	8.93 g	11.90 g	4.76 g
Serine	5.25 g	7.88 g	10.50 g	4.20 g
Sodium hydroxide	1.464 g	2196 g	2.928 g	1.171 g
Sodium chloride	0.473 g	0.710 g	0.946 g	0.378 g
Sodium acetate trihydrate	0.313 g	0.470 g	0.626 g	0.250 g
Potassium acetate	4.611 g	6.917 g	9.222 g	3.689 g
Magnesium acetate tetrahydrate	1.137 g	1.706 g	2.274 g	0.910 g
Calcium chloride dihydrate	0.779 g	1.168 g	1.558 g	0.623 g

Electrolyte contents and physico-chemical characteristics of Nutriflex Lipid special after mixing the chamber bags:

Electrolytes	in 1250 ml Size 1	in 1875 ml Size 2	in 2500 ml Size 3	Quantity per 1000 ml
Sodium	67 mmol	100.5 mmol	134 mmol	53.6 mmol
Potassium	47 mmol	70.5 mmol	94 mmol	37.6 mmol
Magnesium	5.3 mmol	7.95 mmol	10.6 mmol	4.2 mmol
Calcium	5.3 mmol	7.95 mmol	10.6 mmol	4.2 mmol
Zinc	0.04 mmol	0.06 mmol	0.08 mmol	0.03 mmol
Chloride	60 mmol	90 mmol	120 mmol	48 mmol
Acetate	60 mmol	90 mmol	120 mmol	48 mmol
Phosphate	20 mmol	30 mmol	40 mmol	16 mmol

Amino acid content	70.1 g	105.1 g	140.1 g	56.0 g
Nitrogen content	10 g	15 g	20 g	s g
Carbohydrate content	180 g	270 g	360 g	144 g
Lipid content	50 g	75 g	100 g	40 g

Energy in the form of lipids	1990 kJ (475 kcal)	2985 kJ (715 kcal)	3980 kJ (950 kcal)	1590 kJ (380 kcal)
Energy in the form of carbohydrates	3015 kJ (720 kcal)	4520 kJ (1080 kcal)	6030 kJ (1440 kcal)	2415 kJ (575 kcal)
Energy in the form of amino acids	1170 kJ (280 kcal)	1755 kJ (420 kcal)	2340 kJ (560 kcal)	940 kJ (225 kcal)
Non-protein energy	5005 kJ (1195 kcal)	7510 kJ (1795 kcal)	10010 kJ (2390 kcal)	4005 kJ (955 kcal)
Total energy	6175 kJ (1475 kcal)	9265 kJ (2215 kcal)	12350 kJ (2950 kcal)	4945 kJ (1180 kcal)
Osmolality	2115 mOsm/kg	2115 mOsm/kg	2115 mOsm/kg	2115 mOsm/kg
Theoretical osmolarity	1545 mOsm/l	1545 mOsm/l	1545 mOsm/l	1545 mOsm/l
pH	5.0 - 6.0	5.0 - 6.0	5.0 - 6.0	5.0 - 6.0

What NuTRIflex Lipid special looks like and contents of the pack

The ready-to-use product is an emulsion for infusion, Le. it is administered through a small tube into a vein.

NuTRIflex Lipid special 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: 5x 1250 ml, 5 x 1875 ml and 5x 2500 ml Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

B. Braun Melsungen AG

Carl-Braun-Str. 1 Postal address:

34212 Melsungen, Germany 34209 Melsungen, Germany

Tel.: +49-(0)-5661-71-0 Fax: +49-(0)-5661-71-4567

This leaflet was last revised in 02/2014

The other ingredients are citric acid monohydrate, egg lecithin, glycerol, sodium oleate and water for injections.

The following information is intended for healthcare professionals only:

NuTRIflex Lipid special is supplied in containers for single use. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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 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.

B BRAUN

B. Braun Melsungen AG

34209 Melsungen, Germany