1. what lipoflex special without electrolytes is and what it is used for

Lipoflex special without electrolytes 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.

You are given Lipoflex 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 lipoflex special without electrolytes

Do not use Lipoflex special without electrolytes

• if you are allergic to any of the active substances, 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 Lipoflex 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 (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 Lipoflex 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 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 B 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

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

Other medicines and Lipoflex special without electrolytes

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

Lipoflex special without electrolytes can interact with some other medicines. Please tell your doctor, pharmacist or nurse 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 Lipoflex special without electrolytes 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. Lipoflex 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’.

3. how to use lipoflex 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 or pharmacist 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 Lipoflex 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 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 (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 or pharmacist.

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 Lipoflex 56/144 special without electrolytes 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)

5. how to store lipoflex special without electrolytes

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 day of that month.

6. contents of the pack and other information

What Lipoflex special without electrolytes 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
Soya-bean oil, refined	20.00 g	12.50 g	25.00 g	37.50 g
Medium-chain triglycerides	20.00 g	12.50 g	25.00 g	37.50 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
	in 1000 ml	in 625 ml	in 1250 ml	in 1875 ml
Amino acid content	56.0 g	35.0 g	70.1 g	105.1 g
Nitrogen content	8 g	5 g	10 g	15 g
Carbohydrate content	144 g	90 g	180 g	270 g
Lipid content	40 g	25 g	50 g	75 g

B|BRAUN

	Energy in the form of lipids Energy in the form	1590 kJ (380 kcal) 2415 kJ	995 kJ (240 kcal) 1510 kJ	1990 kJ	2985 kJ
				f/17R l/nnll (71 £ l/nnll
				(4/5 kcal) (7 15 kcal)
				3015 kJ	4520 kJ
	of carbohydrates	(575 kcal)	(360 kcal)	(720 kcal) (1080 kcal)
	Energy in the form	940 kJ	585 kJ	1170 kJ	1755 kJ
	of amino acids	(225 kcal)	(140 kcal)	(280 kcal) (420 kcal)
	Non-protein energy	4005 kJ	2505 kJ	5005 kJ	7505 kJ
		(955 kcal)	(600 kcal)	(1195 kcal) (1795 kcal)
	Total energy Osmolality Theoretical osmolarity pH	4945 kJ (1180 kcal)	3090 kJ (740 kcal)	6175 kJ 9260 kJ (1475 kcal) (2215 kcal) 1840 mOsm/kg 1330 mOsm/l 5.0 – 6.0

The other ingredients are citric acid monohydrate (for pH adjustment), egg phospholipids for injection, glycerol, sodium oleate, all-rac-alpha-tocopherol and water for injections.

What Lipoflex 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.

Lipoflex special without electrolytes 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)

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 or 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 × 625 ml, 5 × 1250 ml and 5 × 1875 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

Figure A

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.

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 seams 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 turned 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.

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 (Fig. 7) from the infusion port 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.

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 pm).

Shelflife 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.

Shelflife 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.

Lipoflex special without electrolytes must not be mixed with other medicinal products for which compatibility has not 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.

Lipoflex plus should not be given simultaneously with blood in the same infusion set due to the risk of pseudoaggluti­nation.

Duration of infusion of one single bag

The recommended duration of infusion for a parenteral nutrition bag is maximum 24 h.

B|BRAUN

	Energy in the form of lipids Energy in the form	1590 kJ (380 kcal) 2415 kJ	995 kJ (240 kcal) 1510 kJ	1990 kJ	2985 kJ
				f/17R l/nnll (71 £ l/nnll
				(4/5 kcal) (7 15 kcal)
				3015 kJ	4520 kJ
	of carbohydrates	(575 kcal)	(360 kcal)	(720 kcal) (1080 kcal)
	Energy in the form	940 kJ	585 kJ	1170 kJ	1755 kJ
	of amino acids	(225 kcal)	(140 kcal)	(280 kcal) (420 kcal)
	Non-protein energy	4005 kJ	2505 kJ	5005 kJ	7505 kJ
		(955 kcal)	(600 kcal)	(1195 kcal) (1795 kcal)
	Total energy Osmolality Theoretical osmolarity pH	4945 kJ (1180 kcal)	3090 kJ (740 kcal)	6175 kJ 9260 kJ (1475 kcal) (2215 kcal) 1840 mOsm/kg 1330 mOsm/l 5.0 – 6.0

The other ingredients are citric acid monohydrate (for pH adjustment), egg phospholipids for injection, glycerol, sodium oleate, all-rac-alpha-tocopherol and water for injections.

What Lipoflex 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.

Lipoflex special without electrolytes 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)

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 or 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 × 625 ml, 5 × 1250 ml and 5 × 1875 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

Figure A

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.

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 seams 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 turned 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.

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 (Fig. 7) from the infusion port 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.

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 pm).

Shelflife 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.

Shelflife 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.

Lipoflex special without electrolytes must not be mixed with other medicinal products for which compatibility has not 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.

Lipoflex plus should not be given simultaneously with blood in the same infusion set due to the risk of pseudoaggluti­nation.

Duration of infusion of one single bag

The recommended duration of infusion for a parenteral nutrition bag is maximum 24 h.

B|BRAUN

B. Braun Melsungen AG

34209 Melsungen, Germany

12617497_Lipoflex special woE_GIF-210×594__GB.indd 2

24.09.20 10:01