Lipoflex

Package leaflet: Information for the user

Lipoflex, AA 56 / G 144 infusion emulsion

Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Lipoflex, AA 56 / G 144 is and what it is used for
2. What you need to know before using Lipoflex, AA 56 / G 144
3. How to use Lipoflex, AA 56 / G 144
4. Possible side effects
5. How to store Lipoflex, AA 56 / G 144
6. Contents of the pack and other information

1. What Lipoflex, AA 56 / G 144 is and what it is used for

Lipoflex, AA 56 / G 144 contains liquids and substances called amino acids, electrolytes, and fatty acids, which are essential for the body to grow or heal. It also provides calories in the form of carbohydrates and fats.
Lipoflex, AA 56 / G 144 is administered to you when you are unable to eat normally. This may occur in many situations, for example after surgery, injuries or burns, or if you are unable to absorb food through the stomach and intestines.

2. What you need to know before using Lipoflex, AA 56 / G 144

Do not use Lipoflex, AA 56 / G 144

• if you are allergic to any of the active substances, eggs, peanuts, soy, or any of the other ingredients of this medicine (listed in section 6).
• this medicine must not be administered to neonates, infants, or children under two years of age.

Also, do not use Lipoflex, AA 56 / G 144 if you have any of the following conditions:

• potentially life-threatening circulatory disorders, such as those occurring in cases of collapse or shock
• heart attack or stroke
• severe impairment of blood coagulation, risk of bleeding (severe coagulopathy, worsening hemorrhagic diathesis)
• blockage of blood vessels by blood clots or fat (embolism)
• severe liver failure
• impaired bile flow (intrahepatic cholestasis)
• severe renal failure without renal replacement therapy
• imbalances in the body's electrolyte levels
• fluid deficiency or excess water in the body
• fluid in the lungs (pulmonary edema)
• severe heart failure
• certain metabolic disorders, such as:
  • excessive lipids (fats) in the blood
  • congenital amino acid metabolism disorders
  • excessively high blood sugar levels requiring more than 6 units of insulin per hour to remain under control
  • metabolic disturbances that may occur after surgery or trauma
  • coma of unknown origin
  • inadequate oxygen supply to tissues
  • excessively high levels of acids in the blood.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Lipoflex, AA 56 / G 144.
Inform your doctor if:

• you have heart, liver, or kidney problems
• you suffer from certain metabolic disorders such as diabetes, abnormal blood lipid levels, imbalances in body fluids and electrolytes, or disturbances in acid-base balance.

You will be closely monitored for early signs of an allergic reaction (such as fever, chills, skin rash, or labored breathing) while receiving this medicine.
Additional monitoring and tests, including various blood tests, will be performed to ensure your body is properly utilizing the administered nutrients.
The medical staff may also take appropriate measures to ensure adequate fluid and electrolyte intake according to your needs. In addition to Lipoflex, AA 56 / G 144, you may receive other nutritional substances (nutrients) to fully meet your nutritional requirements.

Children
This medicine must not be administered to neonates, infants, or children under two years of age.

Other medicines and Lipoflex, AA 56 / G 144
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Lipoflex, AA 56 / G 144 may interact with other medicines. Inform your doctor, pharmacist, or nurse if you are taking or are being administered any of the following medicines:

• insulin
• heparin
• medicines that prevent inappropriate blood clotting, such as warfarin or other coumarin derivatives
• medicines that promote urine flow (diuretics)
• medicines used to treat high blood pressure (ACE inhibitors)
• medicines used to treat high blood pressure or heart problems (angiotensin II receptor antagonists)
• medicines used in organ transplantation, such as cyclosporine and tacrolimus
• medicines used to treat inflammation (corticosteroids)
• hormonal preparations affecting fluid balance (adrenocorticotropic hormone or ACTH)

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine. If you are pregnant, you will be given this medicine only if your doctor or pharmacist considers it essential for your recovery. There are no available data on the use of Lipoflex, AA 56 / G 144 in pregnant women.
Breastfeeding is not recommended for women receiving parenteral nutrition.

Driving and using machines
This medicine is normally administered to immobilized patients, e.g., in hospital or clinic settings, who therefore do not drive or operate machinery. In any case, this medicine has no effect on the ability to drive or operate machinery.

3. How to use Lipoflex, AA 56 / G 144

This medicine is administered by intravenous infusion (drip), i.e. through a small tube inserted directly into a vein. The medicine is given exclusively into one of the large veins (central veins).
Your doctor or pharmacist will determine the amount of medicine you need and the duration of treatment with this medicine.

Use in children
This medicine must not be given to neonates, infants, or children under two years of age.

If you use more Lipoflex, AA 56 / G 144 than you should
If you have received an excessive amount of this medicine, you may experience the so-called "overload syndrome" with the following symptoms:

• excess fluid and electrolyte disturbances
• fluid in the lungs (pulmonary edema)
• loss of amino acids in the urine and disturbances in amino acid balance
• vomiting, nausea
• chills
• high blood sugar levels
• glucose in the urine
• fluid deficit
• excessive concentration of the blood (hyperosmolarity)
• reduced or loss of consciousness due to extremely high blood sugar levels
• enlargement of the liver (hepatomegaly) with or without jaundice
• enlargement of the spleen (splenomegaly)
• fat deposition in internal organs
• changes in liver function parameters
• low red blood cell count in the blood (anemia)
• reduced white blood cell count (leukopenia)
• reduced platelet count (thrombocytopenia)
• increase in immature red blood cells (reticulocytosis)
• breakdown of blood cells (hemolysis)
• bleeding or tendency to bleed
• blood coagulation disorders (characterized by changes in bleeding time, coagulation time, prothrombin time, etc.)
• fever
• high levels of fats in the blood
• loss of consciousness

If any of these symptoms occur, the infusion must be stopped immediately.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

The following side effects can be serious. If you experience any of the following, contact your doctor immediately,
who will stop treatment with 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):

• nausea, vomiting, loss of appetite

Rare (may affect up to 1 in 1,000 users):

• increased tendency of the blood to clot
• bluish discoloration of the skin
• shortness of breath
• headache
• hot flushes
• skin redness (erythema)
• sweating
• chills
• feeling cold
• elevated body temperature
• drowsiness
• chest, back, bone or lower back pain
• decreased or increased blood pressure

Very rare (may affect up to 1 in 10,000 people):

• excessive levels of fats or sugars in the blood
• elevated levels of acidic substances in the blood
• An excess of lipids may lead to a lipid overload syndrome; for further information see “If you use more Lipoflex, AA 56 / G 144 than you should” in section 3. Symptoms usually resolve upon discontinuation of the infusion.

Not known (frequency cannot be estimated from the available data):

• low white blood cell count (leucopenia)
• low platelet count in the blood (thrombocytopenia)
• impairment of bile flow (cholestasis)

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.

You may also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lipoflex, AA 56 / G 144

Keep this medicine out of the sight and reach of children.
Do not store above 25 °C.
Do not freeze. If accidental freezing occurs, discard the bag.
Keep the bag in its protective outer packaging to protect the medicine from light.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of that month.

6. Pack contents and other information

What Lipoflex, AA 56 / G 144 contains
The active substances contained in the ready-to-use mixture are:

The other components are citric acid monohydrate (to adjust pH), egg lecithin, glycerol, sodium oleate,
all-rac-alpha-tocopherol and water for injections.
Description of the appearance of Lipoflex, AA 56 / G 144 and contents of the pack
The ready-to-use product is an infusion emulsion, meaning it is administered through a tube inserted into a vein.
Lipoflex, AA 56 / G 144 is supplied in flexible multi-compartment bags containing:

• 625 ml (250 ml amino acid solution + 125 ml lipid emulsion + 250 ml glucose solution)
• 1,250 ml (500 ml amino acid solution + 250 ml lipid emulsion + 500 ml glucose solution)
• 1,875 ml (750 ml amino acid solution + 375 ml lipid emulsion + 750 ml glucose solution)

Figure A Figure B
Figure A: the multi-compartment bag is enclosed in a protective overwrap. Between the bag and the overwrap are an oxygen absorber and an oxygen indicator; the oxygen absorber sachet is made of inert material and contains iron hydroxide.
Figure B: the upper compartment contains a glucose solution, the middle compartment contains a lipid emulsion and the lower compartment contains an amino acid solution.
The glucose and amino acid solutions are clear and colourless or pale yellow. The lipid emulsion is white and opalescent in appearance.
The upper and middle compartments can be connected to the lower compartment by opening the intermediate seals.
Different container sizes are packaged in boxes containing five bags.
Pack sizes: 5 x 625 ml, 5 x 1,250 ml and 5 x 1,875 ml
It is possible that not all pack sizes are marketed.
Marketing Authorisation Holder and Manufacturer
B. Braun Melsungen AG
Carl-Braun-Str. 1 Postal address:
34212 Melsungen, Germany 34209 Melsungen, Germany
Tel.: +49--5661-71-0
Fax: +49--5661-71-4567
This medicinal product is authorised in the European Economic Area Member States under the following
names:
Austria Nutriflex Lipid special B. Braun
Belgium Nutriflex Lipid special 56 g/l AA + 144 g/l G, emulsie voor infusie
Denmark Lipoflex special
Finland Nutriflex Lipid 56/144/40
France LIPOFLEX LIPIDE G144/N8/E, émulsion pour perfusion
Germany Nutriflex Lipid 56/144 special
Iceland Nutriflex Lipid 56/144 special
Italy Lipoflex, AA 56 / G 144
Luxembourg Nutriflex Lipid 56/144 special
Netherlands Nutriflex Lipid special, 56 g/l + 144 g/l emulsie voor infusie
Norway Lipoflex special
Poland Lipoflex special
Spain Nutriflex Lipid 56/144 special Emulsión para perfusión
Sweden Nutriflex Lipid 56/144/40
United Kingdom Lipoflex special emulsion for infusion
______________________________________________________________________________
The following information is intended for medical or healthcare professionals only:
No special instructions for disposal.
Before use, parenteral nutrition products must be visually inspected for any damage, discolouration and emulsion instability.
Do not use damaged bags. The overwrap, primary bag and seals between compartments must be intact. Use only if the amino acid and glucose solutions are clear and colourless to pale yellow, and if the lipid emulsion is homogeneous and white and opalescent. Do not use if the solutions contain particles.
After mixing the three compartments, do not use if the emulsion shows discolouration or signs of phase separation (oil droplets, oily layer). Immediately stop the infusion if discolouration or signs of phase separation occur.
Before opening the overwrap, check the colour of the oxygen indicator (see Figure A). Do not use if the oxygen indicator is pink. Use only if the oxygen indicator is yellow.
Preparation of the emulsion by mixing
Aseptic procedures must be strictly followed.
To open: tear the overwrap starting at the designated slits (Fig. 1). Remove the bag from the protective overwrap. Discard the overwrap, oxygen indicator and oxygen absorber.
Visually inspect the primary bag for any leaks. Leaking bags must be discarded, as sterility cannot be guaranteed.

To open and progressively mix the compartments, roll the bag with both hands, pressing on the seal separating the upper compartment (glucose) from the lower compartment (amino acids) (Fig. 2a). Continue pressing until the seal between the middle compartment (lipids) and the lower compartment opens (Fig. 2b).
After removing the aluminium closure (Fig. 3), compatible additives may be added via the medication addition port (Fig. 4).

Carefully mix the contents of the bag (Fig. 5) and visually inspect the mixture (Fig. 6). No signs of emulsion phase separation should be visible.
The mixture is a homogeneous oil-in-water emulsion, white and opalescent in appearance.
Preparation of the infusion
The emulsion must always be brought to room temperature before infusion.
Remove the aluminium film (Fig. 7) from the infusion port and connect the infusion set (Fig. 8). Use a non-vented infusion set or close the air vent if using a vented set. Hang the bag on an IV pole (Fig. 9) and administer the infusion according to standard techniques.

For single use only. The container and any unused residue must be discarded after use. Do not reconnect a partially used container.
If filters are used, they must be lipid-permeable (pore size ≥1.2 µm).
Stability period after removal of the protective overwrap and mixing of the bag contents
Chemical and physicochemical stability of the mixture of amino acids, glucose and fats has been demonstrated for 7 days at 2–8°C and for an additional 2 days at 25°C.
Stability period after addition of compatible additives
From a microbiological standpoint, the product should be used immediately after additive addition.
If the product is not used immediately after additive addition, the user is responsible for the storage times and conditions during use.
The emulsion must be used immediately after opening the container.
Lipoflex, AA 56 / G 144 must not be mixed with other medicinal products unless compatibility has been documented. Compatibility data for various additives (e.g. electrolytes, trace elements, vitamins) and shelf lives for such mixtures are available from the manufacturer upon request.
Lipoflex, AA 56 / G 144 must not be administered simultaneously with blood transfusion through the same infusion set due to the risk of pseudoagglutination.
Duration of infusion of a single bag
The recommended infusion duration for a parenteral nutrition bag is a maximum of 24 hours.

Package leaflet: information for the user

Lipoflex, AA32/G64 emulsion for infusion

Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Lipoflex, AA32/G64 is and what it is used for
2. What you need to know before using Lipoflex, AA32/G64
3. How to use Lipoflex, AA32/G64
4. Possible side effects
5. How to store Lipoflex, AA32/G64
6. Contents of the pack and other information

---

1. What Lipoflex, AA32/G64 is and what it is used for

Lipoflex, AA32/G64 contains liquids and substances called amino acids, electrolytes, and fatty acids, which are essential for the body to grow or heal. It also provides calories in the form of carbohydrates and fats.
Lipoflex, AA32/G64 is administered to you when you are unable to eat normally. This may occur in many situations, for example after surgery, trauma, or burns, or if you are unable to absorb food through the stomach and intestines.

---

2. What you need to know before using Lipoflex, AA32/G64

Do not use Lipoflex, AA32/G64

• if you are allergic to any of the active substances, to eggs, peanuts, soy, or to any of the other ingredients of this medicine (listed in section 6).
• This medicine must not be administered to newborns, infants, or children under two years of age.

Additionally, do not use Lipoflex, AA32/G64 if you have any of the following conditions:

• potentially life-threatening circulatory disorders, such as those occurring in shock or collapse
• heart attack or stroke
• severe impairment of blood coagulation, risk of bleeding (severe coagulopathy, worsening hemorrhagic diathesis)
• blockage of blood vessels by blood clots or fat (embolism)
• severe liver failure
• impaired bile flow (intrahepatic cholestasis)
• severe kidney failure in the absence of renal replacement therapy
• imbalances in the body's salt content
• fluid deficiency or excess water in the body
• fluid in the lungs (pulmonary edema)
• severe heart failure
• certain metabolic disorders, such as:
  • too many lipids (fats) in the blood
  • congenital disorders of amino acid metabolism
  • excessively high blood sugar levels requiring more than 6 units of insulin per hour to control
  • metabolic abnormalities that may occur after surgery or trauma
  • coma of unknown origin
  • inadequate oxygen supply to tissues
  • excessively high levels of acids in the blood

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Lipoflex, AA32/G64.
Inform your doctor if:

• you have heart, liver, or kidney problems
• you suffer from certain metabolic disorders such as diabetes, abnormal blood lipid levels, imbalances in body fluids and electrolytes, or disturbances in acid-base balance. You will be closely monitored for early signs of an allergic reaction (such as fever, chills, rash, or shortness of breath) when receiving this medicine.

Other checks and tests, including various blood tests, will be performed to ensure your body is properly utilizing the nutrients provided.
The nursing staff may also take appropriate measures to ensure adequate fluid and electrolyte intake according to your needs.
In addition to Lipoflex, AA32/G64, you may receive other nutritional substances (nutrients) to fully meet your requirements.

Children
This medicine must not be administered to newborns, infants, or children under two years of age.

Other medicines and Lipoflex, AA32/G64
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Lipoflex, AA32/G64 may interact with other medicines. Inform your doctor, pharmacist, or nurse if you are taking or are being given any of the following medicines:

• insulin
• heparin
• medicines that prevent inappropriate blood clotting, such as warfarin or other coumarin derivatives
• medicines that promote urine flow (diuretics)
• medicines used to treat high blood pressure (ACE inhibitors)
• medicines used to treat high blood pressure or heart problems (angiotensin II receptor antagonists)
• medicines used in organ transplantation, such as cyclosporine and tacrolimus
• medicines used to treat inflammation (corticosteroids)
• hormonal preparations affecting fluid balance (adrenocorticotropic hormone or ACTH)

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. If you are pregnant, you will receive this medicine only if your doctor or pharmacist considers it essential for recovery. There are no data available on the use of Lipoflex, AA32/G64 in pregnant women.
Breastfeeding is not recommended for women receiving parenteral nutrition.

Driving and using machines
This medicine is normally administered to immobilized patients, e.g., in hospital or clinic settings, who therefore do not drive or operate machinery. In any case, this medicine has no effect on the ability to drive or operate machinery.

---

3. How to use Lipoflex, AA32/G64

This medicine is administered by intravenous infusion (drip), through a small tube inserted directly into a vein. The medicine may be given through either small veins (peripheral veins) or large veins (central veins).

Your doctor or pharmacist will determine the amount of medicine you need and the duration of treatment.

Use in children
This medicine must not be administered to newborns, infants, or children under two years of age.

If you use more Lipoflex, AA32/G64 than you should
If you have received an excessive amount of this medicine, you may develop so-called "overload syndrome" with the following symptoms:

• excess fluid and electrolyte disturbances
• fluid in the lungs (pulmonary edema)
• loss of amino acids in urine and amino acid imbalance
• vomiting, nausea
• chills
• high blood sugar levels
• glucose in urine
• fluid deficiency
• excessive concentration of blood (hyperosmolarity)
• reduced or lost consciousness due to extremely high blood sugar levels
• enlargement of the liver (hepatomegaly), with or without jaundice
• enlargement of the spleen (splenomegalia)
• fat deposition in internal organs
• changes in liver function parameters
• reduction or loss of red blood cells in the blood (anemia)
• reduction in white blood cell count (leukopenia)
• reduction in platelet count (thrombocytopenia)
• increase in immature red blood cells (reticulocytosis)
• breakdown of blood cells (hemolysis)
• bleeding or tendency to bleed
• disturbances in blood coagulation (characterized by changes in bleeding time, coagulation time, prothrombin time, etc.)
• fever
• high levels of fat in the blood
• loss of consciousness

If any of these symptoms occur, the infusion must be stopped immediately.
If you have any doubts about the use of this medicine, consult 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 can be serious. If you experience any of the following side effects, contact your doctor immediately, who will stop administration of 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:
Common (may affect up to 1 in 10 people):

• irritation or inflammation of the veins (phlebitis, thrombophlebitis)

Uncommon (may affect up to 1 in 100 people):

• nausea, vomiting, loss of appetite

Rare (may affect up to 1 in 1,000 people):

• increased tendency of blood to clot
• bluish discoloration of the skin
• shortness of breath
• headache
• hot flushes
• redness of the skin (erythema)
• sweating
• chills
• feeling cold
• elevated body temperature
• drowsiness
• chest, back, bone or lower back pain
• decreased or increased blood pressure

Very rare (may affect up to 1 in 10,000 people):

• excessively high levels of fats or sugars in the blood

• high levels of acidic substances in the blood

• An excess of lipids may lead to a lipid overload syndrome; for further information see “If you use more Lipoflex AA32/G64 than you should” in section 3. Symptoms usually resolve upon discontinuation of the infusion.
  Not known (frequency cannot be estimated from the available data):

• decreased white blood cell count (leukopenia)

• decreased platelet count in the blood (thrombocytopenia)

• impairment of bile flow (cholestasis)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lipoflex AA32/G64

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 its protective outer packaging to protect the medicine from light.
Do not use this medicine after the expiry date 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, AA32/G64 contains
The active substances contained in the ready-to-use mixture are:

The other components are citric acid monohydrate (to adjust pH), egg lecithin, glycerol, sodium oleate,
all-rac-alpha-tocopherol and water for injections.
Description of the appearance of Lipoflex, AA32/G64 and contents of the pack
The ready-to-use product is an infusion emulsion, meaning it is administered through a small tube inserted
into a vein.
Lipoflex, AA32/G64 is supplied in flexible multi-compartment bags containing:

• 1,250 ml (500 ml of amino acid solution + 250 ml of lipid emulsion + 500 ml of glucose solution)
• 1,875 ml (750 ml of amino acid solution + 375 ml of lipid emulsion + 750 ml of glucose solution)
• 2,500 ml (1,000 ml of amino acid solution + 500 ml of lipid emulsion + 1,000 ml of glucose solution)

Figure A Figure B
Figure A: the multichamber bag is wrapped in a protective overwrap. Between the bag and the overwrap there is an oxygen absorber and an oxygen indicator; the sachet of the oxygen absorber is made of inert material and contains iron hydroxide.
Figure B: the upper chamber contains a glucose solution, the middle chamber contains a lipid emulsion, and the lower chamber contains an amino acid solution.
The glucose and amino acid solutions are clear and colourless or pale yellow. The lipid emulsion is white and milky in appearance.
The upper and middle chambers can be connected to the lower chamber by opening the intermediate seals.
Different container sizes are packaged in boxes containing five bags.
Pack sizes: 5 x 1.250 ml, 5 x 1.875 ml and 5 x 2.500 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 medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Austria Nutriflex Lipid peri B. Braun
Belgium Nutriflex Lipid peri, 32 g/l AA + 64 g/l G , emulsie voor infusie
Bulgaria Nutriflex Lipid 32/64 peri emulsion for infusion
Czech Republic Nutriflex Lipid peri 32/64,
Denmark Lipoflex peri
Finland Nutriflex Lipid 32/64/40 perifer
France Lipoflex Lipide G64/N4,6/E, émulsion pour perfusion
Germany Nutriflex Lipid 32/64 peri
Iceland Nutriflex Lipid 32/64 peri
Italy Lipoflex, AA32/G64 emulsione per infusione
Luxembourg Nutriflex Lipid 32/64 peri
Netherlands Nutriflex Lipid peri, 32 g/l + 64 g/l,
emulsie voor infusie
Norway Lipoflex peri
Poland Lipoflex peri
Romania Lipoflex peri emulsie perfuzabila
Slovakia Nutriflex Lipid Peri 32/64,
Spain Nutriflex Lipid 32/64 peri emulsión para perfusión
Sweden Nutriflex Lipid 32/64 perifer
United Kingdom Lipoflex peri emulsion for infusion
______________________________________________________________________________
The following information is intended for healthcare professionals only:
No special requirements for disposal.
Before use, parenteral nutrition products must be visually inspected for damage, discolouration and emulsion instability.
Do not use damaged bags. The overwrap, primary bag and seals between chambers must be intact. Use only if the amino acid and glucose solutions are clear and colourless to pale yellow, and if the lipid emulsion is homogeneous and white and milky in appearance. Do not use if the solutions contain particles.
After mixing the three chambers, do not use if the emulsion shows discolouration or signs of phase separation (oily droplets, oily layer). Immediately discontinue infusion if discolouration or phase separation occurs.
Before opening the overwrap, check the colour of the oxygen indicator (see Figure A). Do not use if the oxygen indicator is pink. Use only if the oxygen indicator is yellow.
Preparation of the emulsion by mixing
Aseptic techniques must be strictly observed.
To open: tear the overwrap starting at the designated notches (Fig. 1). Remove the bag from the protective overwrap. Discard the overwrap, oxygen indicator and oxygen absorber.
Visually inspect the primary bag for leaks. Leaking bags must be discarded, as sterility cannot be guaranteed.

To open and progressively mix the chambers, roll the bag with both hands, applying pressure on the seal separating the upper chamber (glucose) from the lower chamber (amino acids) (Fig. 2a). Continue applying pressure until the seal between the middle chamber (lipids) and the lower chamber opens (Fig. 2b).
After removing the aluminium closure (Fig. 3), compatible additives may be added through the medication port (Fig. 4).

Carefully mix the contents of the bag (Fig. 5) and visually inspect the mixture (Fig. 6). No signs of emulsion phase separation should be visible.
The resulting mixture is a homogeneous oil-in-water emulsion, white and milky in appearance.
Preparation of infusion
The emulsion must always be brought to room temperature before infusion.
Remove the aluminium film (Fig. 7) from the infusion port and connect the infusion set (Fig. 8). Use a non-vented infusion set or close the air vent if a vented set is used. Hang the bag on an IV pole (Fig. 9) and administer infusion according to standard techniques.

For single use only. The container and any unused residue must be discarded after use. Do not reconnect a partially used container.
If filters are used, they must be lipid-permeable (pore size ≥1.2 µm).
Stability period after removal of the protective overwrap and mixing of the bag contents
Chemical and physicochemical stability of the mixture of amino acids, glucose and fats has been demonstrated for 7 days at 2-8°C and for an additional 2 days at 25°C.
Stability period after addition of compatible additives
From a microbiological standpoint, the product should be used immediately after additive addition.
If the product is not used immediately after additive addition, the user is responsible for the storage times and conditions during use.
The emulsion must be used immediately after opening the container.
Lipoflex, AA32/G64 must not be mixed with other medicinal products unless compatibility has been documented. Compatibility data for various additives (e.g. electrolytes, trace elements, vitamins) and shelf lives for such mixtures are available upon request from the manufacturer.
Lipoflex, AA32/G64 must not be administered simultaneously with blood through the same infusion set due to the risk of pseudoagglutination.
Duration of infusion of a single bag
The recommended infusion duration for a parenteral nutrition bag is up to 24 hours.

Package leaflet: information for the user

Lipoflex, AA38/G120 emulsion for infusion

Please read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Lipoflex, AA38/G120 is and what it is used for

2. What you need to know before using Lipoflex, AA38/G120

3. How to use Lipoflex, AA38/G120

4. Possible side effects

5. How to store Lipoflex, AA38/G120

6. Contents of the pack and other information

7. What Lipoflex, AA38/G120 is and what it is used for

Lipoflex, AA38/G120 contains fluids and substances called amino acids, electrolytes, and fatty acids, which are essential for growth and healing. It also provides calories in the form of carbohydrates and fats.
Lipoflex, AA38/G120 is administered when you are unable to eat normally. Various conditions may require its use, such as recovery after surgery, trauma, or burns, or when you are unable to absorb nutrients through the stomach or intestines.

2. What you need to know before using Lipoflex, AA38/G120

Do not use Lipoflex, AA38/G120

• if you are allergic to any of the active substances, eggs, peanuts, soy, or any of the other components of this medicine (listed in section 6).
• This medicine must not be administered to neonates, infants, or children under two years of age.

Also, do not use Lipoflex, AA38/G120 if you have any of the following conditions:

• life-threatening circulatory problems, such as those occurring during collapse or shock
• heart attack or stroke
• severe impairment of blood coagulation, risk of bleeding (severe coagulopathy, worsening hemorrhagic diathesis)
• blockage of blood vessels by blood or fat clots (embolism)
• severe liver failure
• impaired bile flow (intrahepatic cholestasis)
• severe renal failure without renal replacement therapy
• imbalances in body salt levels
• fluid deficiency or excess body water
• fluid in the lungs (pulmonary edema)
• severe heart failure
• certain metabolic disorders, such as:
  • excessive lipids (fats) in the blood
  • congenital disorders of amino acid metabolism
  • abnormally high blood sugar levels requiring more than 6 units of insulin per hour to control
  • metabolic abnormalities that may occur after surgery or injury
  • coma of unknown origin
  • inadequate oxygen supply to tissues
  • abnormally high levels of acid in the blood.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Lipoflex, AA38/G120.
Inform your doctor if:

• you have heart, liver, or kidney problems
• you suffer from certain metabolic disorders such as diabetes, abnormal blood lipid levels, imbalances in body fluid and salt levels, or acid-base disturbances. You will be closely monitored for early signs of an allergic reaction (such as fever, chills, rash, or shortness of breath) while receiving this medicine.

Additional monitoring and tests, including various blood tests, will be performed to ensure your body is properly utilizing the administered nutrients.
Nursing staff may also take measures to ensure your fluid and electrolyte needs are met. In addition to Lipoflex, AA38/G120, you may receive other nutritional substances (food) to fully meet your requirements.

Children
This medicine must not be administered to neonates, infants, or children under two years of age.

Other medicines and Lipoflex, AA38/G120
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Lipoflex, AA38/G120 may interact with other medicines. Inform your doctor, pharmacist, or nurse if you are taking or being administered any of the following medicines:

• insulin
• heparin
• medicines that prevent unwanted blood clotting, such as warfarin or other coumarin derivatives
• medicines that promote urine flow (diuretics)
• medicines used to treat high blood pressure (ACE inhibitors)
• medicines used to treat high blood pressure or heart problems (angiotensin II receptor antagonists)
• medicines used in organ transplantation, such as cyclosporine and tacrolimus
• medicines used to treat inflammation (corticosteroids)
• hormonal preparations affecting fluid balance (adrenocorticotropic hormone or ACTH)

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. You will receive this medicine during pregnancy only if your doctor or pharmacist considers it essential for recovery. There are no available data on the use of Lipoflex, AA38/G120 in pregnant women.
Breastfeeding is not recommended for women receiving parenteral nutrition.

Driving and using machines
This medicine is normally administered to immobilized patients, e.g., in hospital or clinic settings, which excludes the possibility of driving or operating machinery. In any case, this medicine has no effect on the ability to drive or operate machinery.

3. How to use Lipoflex, AA38/G120

This medicine is administered by intravenous infusion (drip), delivered directly into a vein through a small tube. This medicine is administered exclusively into one of the large veins (central veins).

Your doctor or pharmacist will determine the dose you need and the duration of treatment with this medicine.

Use in children
This medicine must not be administered to neonates, infants, or children under two years of age.

If you use more Lipoflex, AA38/G120 than you should
If you have received an excessive amount of this medicine, you may experience the so-called "overload syndrome" with the following symptoms:

• fluid overload and electrolyte disturbances
• fluid in the lungs (pulmonary edema)
• loss of amino acids in urine and disturbances in amino acid balance
• vomiting, nausea
• chills
• high blood sugar levels
• glucose in urine
• fluid deficiency
• abnormally concentrated blood (hyperosmolarity)
• reduced or lost consciousness due to extremely high blood sugar levels
• liver enlargement (hepatomegaly), with or without jaundice
• spleen enlargement (splenomegaly)
• fat deposition in internal organs
• abnormal liver function test results
• reduced red blood cell count (anemia)
• reduced white blood cell count (leukopenia)
• reduced platelet count (thrombocytopenia)
• increased immature red blood cells (reticulocytosis)
• breakdown of blood cells (hemolysis)
• bleeding or tendency to bleed
• impaired blood coagulation (characterized by prolonged bleeding time, coagulation time, prothrombin time, etc.)
• fever
• elevated blood fat levels
• loss of consciousness

If any of these symptoms occur, the infusion must be stopped immediately.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects can be serious. If you experience any of the following side effects, inform your doctor immediately;
the doctor will discontinue administration of 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):

• nausea, vomiting, loss of appetite

Rare (may affect up to 1 in 1,000 people):

• increased tendency of blood to clot
• bluish discoloration of the skin
• shortness of breath
• headache
• hot flushes
• skin redness (erythema)
• sweating
• chills
• feeling cold
• elevated body temperature
• drowsiness
• chest, back, bone or lower back pain
• decreased or increased blood pressure

Very rare (may affect up to 1 in 10,000 people):

• unusually high levels of fats or sugars in the blood
• elevated levels of acidic substances in the blood
• an excess of lipids may lead to a lipid overload syndrome; for further information see “If you use more Lipoflex, AA38/G120 than you should” in section 3. Symptoms usually resolve upon discontinuation of the infusion.

Not known (frequency cannot be estimated from the available data):

• reduced white blood cell count (leucopenia)
• reduced platelet count (thrombocytopenia)
• impairment of bile flow (cholestasis)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lipoflex, AA38/G120

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not freeze. In case of accidental freezing, discard the bag.
Keep the bag in its protective outer packaging to protect the medicine from light.
Do not use this medicine after the expiry date 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, AA38/G120 contains
The active substances contained in the ready-to-use mixture are:

The other components are citric acid monohydrate (to adjust pH), egg lecithin, glycerol, sodium oleate,
all-rac-alpha-tocopherol and water for injections.
Description of the appearance of Lipoflex, AA38/G120 and contents of the pack
The ready-to-use product is an infusion emulsion, i.e. it is administered through a small tube inserted into a vein.
Lipoflex, AA38/G120 is supplied in flexible multi-compartment bags containing:

• 1,250 ml (500 ml of amino acid solution + 250 ml of lipid emulsion + 500 ml of glucose solution)
• 1,875 ml (750 ml of amino acid solution + 375 ml of lipid emulsion + 750 ml of glucose solution)
• 2,500 ml (1,000 ml of amino acid solution + 500 ml of lipid emulsion + 1,000 ml of glucose solution)

Figure A Figure B
Figure A: the multi-compartment bag is enclosed in a protective wrapper. Between the bag and the wrapper there are an oxygen absorber and an oxygen indicator; the sachet of the oxygen absorber is made of inert material and contains iron hydroxide.
Figure B: the upper compartment contains a glucose solution, the middle compartment contains a lipid emulsion, and the lower compartment contains an amino acid solution.
The glucose and amino acid solutions are clear and colourless or pale yellow. The lipid emulsion appears as a white, milky emulsion.
The upper and middle compartments can be connected to the lower compartment by opening the intermediate seals.
Different container sizes are packaged in boxes containing five bags.
Pack sizes: 5 x 1.250 ml, 5 x 1.875 ml and 5 x 2.500 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 medicinal product is authorised in the European Economic Area Member States under the following
names:
Austria Nutriflex Lipid plus B. Braun
Belgium Nutriflex Lipid plus, 38 g/l AA + 120 g/l G, emulsie voor infusie
Czech Republic Nutriflex Lipid plus 38/120
Denmark Lipoflex Plus
Finland Nutriflex Lipid 38/120/40
France LIPOFLEX LIPIDE G120/N5,4/E, émulsion pour perfusion
Germany Nutriflex Lipid 38/120 plus
Iceland Nutriflex Lipid 38/120 plus
Italy Lipoflex, AA38/G120
Luxembourg Nutriflex Lipid 38/120 plus
Netherlands Nutriflex Lipid plus, 38 g/l + 120 g/l, emulsie voor infusie
Norway Lipoflex plus
Poland Lipoflex plus
Romania Lipoflex plus emulsie perfuzabilă
Slovakia Nutriflex Lipid plus 38/120
Spain Nutriflex Lipid 38/120 plus emulsión para perfusión
Sweden Nutriflex Lipid 38/120/40
United Kingdom Lipoflex plus emulsion for infusion
______________________________________________________________________________
The following information is intended exclusively for physicians or healthcare professionals:
No special instructions for disposal.
Before use, parenteral nutrition products must be visually inspected for any damage, colour changes, or emulsion instability.
Do not use damaged bags. The wrapper, primary bag, and seals between compartments must be intact. Use only if the amino acid and glucose solutions are clear and colourless to pale yellow, and if the lipid emulsion is homogeneous and appears white and milky. Do not use if the solutions contain particles.
After mixing the three compartments, do not use if the emulsion shows colour changes or signs of phase separation (oily droplets, oily layer). Immediately discontinue the infusion in case of colour change or signs of phase separation.
Before opening the wrapper, check the colour of the oxygen indicator (see Figure A). Do not use if the oxygen indicator is pink. Use only if the oxygen indicator is yellow.
Preparation of the emulsion by mixing
To open: tear the wrapper starting from the designated slits (Fig. 1). Remove the bag from the protective wrapper. Discard the wrapper, oxygen indicator, and oxygen absorber.
Visually inspect the primary bag for leaks. Bags that leak must be discarded, as sterility cannot be guaranteed.

To open and progressively mix the compartments, roll the bag with both hands, pressing on the seal separating the upper compartment (glucose) from the lower compartment (amino acids) (Fig. 2a). Continue pressing until the seal between the middle compartment (lipids) and the lower compartment opens (Fig. 2b).
After removing the aluminium closure (Fig. 3), compatible additives may be added through the medication addition port (Fig. 4).

Carefully mix the contents of the bag (Fig. 5) and visually inspect the mixture (Fig. 6). No signs of emulsion phase separation should be visible.
The mixture is a homogeneous oil-in-water emulsion, appearing white and milky.
Preparation of the infusion
The emulsion must always be brought to room temperature before infusion.
Remove the aluminium film (Fig. 7) from the infusion port and connect the infusion set (Fig. 8). Use a non-vented infusion set or close the air vent if using a vented set. Hang the bag on an IV pole (Fig. 9) and administer the infusion according to standard techniques.

For single use only. The container and any unused residues must be discarded after use.
Do not reconnect a partially used container.
If filters are used, they must be lipid-permeable (pore size ≥1.2 µm).
Stability period after removal of the protective wrapper and mixing of the bag contents
Chemical and physicochemical stability of the mixture of amino acids, glucose and lipids has been demonstrated for 7 days at 2–8°C and for an additional 2 days at 25°C.
Stability period after addition of compatible additives
From a microbiological standpoint, the product should be used immediately after additive addition.
If the product is not used immediately after additive addition, the user is responsible for the storage times and conditions during use.
The emulsion must be used immediately after opening the container.
Lipoflex, AA38/G120 must not be mixed with other medicinal products unless compatibility has been documented. Compatibility data for various additives (e.g. electrolytes, trace elements, vitamins) and shelf lives for such mixtures can be provided upon request by the manufacturer.
Lipoflex, AA38/G120 must not be administered simultaneously with blood through the same infusion set due to the risk of pseudoagglutination.
Duration of infusion of a single bag
The recommended infusion duration for a parenteral nutrition bag is up to 24 hours.

Package leaflet: information for the user

Lipoflex, AA 56 / G 144 without electrolytes, emulsion for infusion

Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Lipoflex, AA 56 / G 144 without electrolytes is and what it is used for
2. What you need to know before using Lipoflex, AA 56 / G 144 without electrolytes
3. How to use Lipoflex, AA 56 / G 144 without electrolytes
4. Possible side effects
5. How to store Lipoflex, AA 56 / G 144 without electrolytes
6. Contents of the pack and other information

1. What Lipoflex, AA 56 / G 144 without electrolytes is and what it is used for

Lipoflex, AA 56 / G 144 without electrolytes contains fluids and substances called amino acids and fatty acids,
which are essential for the body to grow or heal. It also provides calories in the form of carbohydrates and fats.
Lipoflex, AA 56 / G 144 without electrolytes is administered to you when you are unable to eat
normally. This may occur in many situations, for example after surgery, injuries or
burns, or if you are unable to absorb food through the stomach and intestine.

2. What you need to know before using Lipoflex, AA 56 / G 144 without electrolytes

Do not use Lipoflex, AA 56 / G 144 without electrolytes

• if you are allergic to any of the active substances, to eggs, peanuts, soy, or to any of the other ingredients of this medicine (listed in section 6).
• This medicine must not be administered to neonates, infants, or children under two years of age.

Additionally, do not use Lipoflex, AA 56 / G 144 without electrolytes if you have any of the following conditions:

• potentially life-threatening circulatory disorders, such as those occurring in case of collapse or shock
• heart attack or stroke
• severe impairment of blood coagulation, risk of bleeding (severe coagulopathy, worsening hemorrhagic diathesis)
• obstruction of blood vessels due to blood clots or fat (embolism)
• severe liver failure
• impaired bile flow (intrahepatic cholestasis)
• severe renal failure without renal replacement therapy
• imbalances in the body's salt content
• fluid deficit or excess water in the body
• fluid in the lungs (pulmonary edema)
• severe heart failure
• certain metabolic disorders, such as
  • excessive lipids (fats) in the blood
  • congenital amino acid metabolism disorders
  • excessively high blood sugar levels requiring more than 6 units of insulin per hour to be controlled
  • metabolic abnormalities that may occur after surgery or trauma
  • coma of unknown origin
  • insufficient oxygen supply to tissues
  • abnormally high levels of acid in the blood.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Lipoflex, AA 56 / G 144 without electrolytes.
Inform your doctor if:

• you have heart, liver, or kidney problems
• you suffer from certain types of metabolic disorders such as diabetes, abnormal blood lipid levels, imbalances in body fluids and electrolytes, or disturbances in acid-base balance.

You will be closely monitored for early signs of an allergic reaction (such as fever, chills, skin rash, or shortness of breath) while receiving this medicine.
Additional monitoring and laboratory tests, including various blood tests, will be performed to ensure your body is properly utilizing the nutrients administered.
This medicine is an electrolyte-free solution. The healthcare provider will take measures to ensure adequate intake of fluids and electrolytes according to your needs. In addition to this medicine, you will receive other nutritional substances (nutrients) to fully meet your requirements.
Children
This medicine must not be administered to neonates, infants, or children under two years of age.
Other medicines and Lipoflex, AA 56 / G 144 without electrolytes
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Lipoflex, AA 56 / G 144 without electrolytes may interact with other medicines. Inform your doctor, pharmacist, or nurse if you are taking or are being administered any of the following medicines:

• insulin
• heparin
• medicines that prevent inappropriate blood clotting, such as warfarin or other coumarin derivatives

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine. If you are pregnant, you will receive this medicine only if your doctor or pharmacist considers it essential for your recovery. There are no data available on the use of Lipoflex, AA 56 / G 144 without electrolytes in pregnant women.
Breastfeeding is not recommended for women receiving parenteral nutrition.
Driving and use of machines
This medicine is normally administered to immobilized patients, e.g., in hospital or clinic settings, who therefore do not drive or operate machinery. In any case, this medicine has no effect on the ability to drive or operate machinery.
Lipoflex, AA 56 / G 144 without electrolytes contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per multi-compartment bag, i.e., it is practically "sodium-free".

3. How to use Lipoflex, AA 56 / G 144 without electrolytes

This medicinal product is administered by intravenous infusion (drip), that is, through a small tube inserted directly into a vein. The medicine is administered exclusively into one of the large veins (central veins).
Your doctor or pharmacist will determine the amount of medicine you need and the duration of treatment with this medicine.

Use in children
This medicine must not be administered to neonates, infants, or children under two years of age.

If you use more Lipoflex, AA 56 / G 144 without electrolytes than you should
If you have received an excessive amount of this medicine, you may experience the so-called "overload syndrome" with the following symptoms:

• excess fluid and electrolyte disturbances
• fluid in the lungs (pulmonary edema)
• loss of amino acids in urine and disturbances in amino acid balance
• vomiting, nausea
• chills
• high blood sugar levels
• glucose in urine
• fluid deficit
• excessive concentration of blood (hyperosmolarity)
• reduced or loss of consciousness due to extremely high blood sugar levels
• enlargement of the liver (hepatomegaly) with or without jaundice
• enlargement of the spleen (splenomegaly)
• fat deposition in internal organs
• changes in liver function parameters
• reduced red blood cell count in blood (anemia)
• reduced white blood cell count in blood (leukopenia)
• low platelet count in blood (thrombocytopenia)
• increase in immature red blood cells (reticulocytosis)
• breakdown of blood cells (hemolysis)
• bleeding or tendency to bleed
• blood coagulation disorders (characterized by changes in bleeding time, coagulation time, prothrombin time, etc.)
• fever
• high levels of fats in the blood
• loss of consciousness

If any of these symptoms occur, the infusion must be stopped immediately.

If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects can be serious. If you experience any of the following side effects, inform your
doctor immediately, who will stop administration of 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):

• nausea, vomiting, loss of appetite

Rare (may affect up to 1 in 1,000 people):

• increased tendency of blood to clot
• bluish discoloration of the skin
• shortness of breath
• headache
• hot flushes
• skin redness (erythema)
• sweating
• chills
• feeling cold
• elevated body temperature
• drowsiness
• chest, back, bone or lower back pain
• decrease or increase in blood pressure

Very rare (may affect up to 1 in 10,000 people):

• excessive levels of fats or sugars in the blood
• elevated levels of acidic substances in the blood
• excess of lipids may lead to a lipid overload syndrome; for further information see “If you use more Lipoflex, AA 56 / G 144 without electrolytes than you should” in section 3. Symptoms usually resolve upon discontinuation of the infusion.

Not known (frequency cannot be estimated from the available data):

• reduced white blood cell count (leukopenia)
• reduced platelet count in the blood (thrombocytopenia)
• impairment of bile flow (cholestasis)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lipoflex, AA 56 / G 144 without electrolytes

Keep this medicine out of the sight and reach of children.
Do not store above 25 °C.
Do not freeze. If accidental freezing occurs, discard the bag.
Keep the bag in its protective covering to protect the medicine from light.
Do not use this medicine after the expiry date 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, AA 56 / G 144 without electrolytes contains
The active substances contained in the ready-to-use mixture are:

The other components are citric acid monohydrate (to adjust pH), egg lecithin, glycerol, sodium oleate,
all-rac-alpha-tocopherol and water for injections.
Description of the appearance of Lipoflex, AA 56 / G 144 without electrolytes and contents of the pack
The ready-to-use product is an infusion emulsion, meaning it is administered through a tube inserted
into a vein.
Lipoflex, AA 56 / G 144 without electrolytes is supplied in flexible multi-compartment bags containing:

• 625 ml (250 ml of amino acid solution + 125 ml of lipid emulsion + 250 ml of glucose solution)
• 1,250 ml (500 ml of amino acid solution + 250 ml of lipid emulsion + 500 ml of glucose solution)
• 1,875 ml (750 ml of amino acid solution + 375 ml of lipid emulsion + 750 ml of glucose solution)

Figure A Figure B
Figure A: the multi-compartment bag is enclosed in a protective overwrap. Between the bag and the overwrap there is an oxygen absorber and an oxygen indicator; the oxygen absorber sachet is made of inert material and contains iron hydroxide.
Figure B: the upper compartment contains a glucose solution, the middle compartment contains a lipid emulsion, and the lower compartment contains an amino acid solution.
The glucose and amino acid solutions are clear and colourless or pale yellow. The lipid emulsion is a white, milky-looking emulsion.
The upper and middle compartments can be connected to the lower compartment by opening the intermediate seals.
Different container sizes are packaged in boxes containing five bags.
Pack sizes: 5 x 625 ml, 5 x 1.250 ml and 5 x 1.875 ml
It is possible that not all pack sizes are 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 medicinal product is authorised in the European Economic Area Member States under the following
names:
Austria Nutriflex Lipid special ohne Elektrolyte B.Braun
Belgium Nutriflex Lipid special EF, 56 g/l AA + 144 g/l G, emulsie voor infusie
France Lipoflex Lipide G144/N8, émulsion pour perfusion
Germany Nutriflex Lipid 56/144 special ohne Elektrolyte
Italy Lipoflex, AA 56 / G 144 without electrolytes
Luxembourg Nutriflex Lipid 56/144 special ohne Elektrolyte
Netherlands Nutriflex Lipid pecial zonder elektrolyten, 56 g/l + 144 g/l, emulsie voor infusie
Spain Nutriflex Lipid 56/144 special without electrolytes emulsión para perfusión
United Kingdom Lipoflex special without electrolytes emulsion for infusion
______________________________________________________________________________
The following information is intended for healthcare professionals only:
No special instructions for disposal.
Before use, parenteral nutrition products must be visually inspected for signs of damage, discolouration and emulsion instability.
Do not use damaged bags. The overwrap, primary bag and compartment seals must be intact. Use only if the amino acid and glucose solutions are clear and colourless to pale yellow, and if the lipid emulsion is homogeneous and white and milky in appearance. Do not use if particles are present in the solutions.
After mixing the three compartments, do not use if the emulsion shows discolouration or signs of phase separation (oil droplets, oily layer). Immediately discontinue infusion if discolouration or signs of phase separation occur.
Before opening the overwrap, check the colour of the oxygen indicator (see Figure A). Do not use if the oxygen indicator is pink. Use only if the oxygen indicator is yellow.
Preparation of the emulsion by mixing
Aseptic techniques must be strictly observed.
To open: tear the overwrap starting from the designated slits (Fig. 1). Remove the bag from the protective overwrap. Discard the overwrap, oxygen indicator and oxygen absorber.
Visually inspect the primary bag for leaks. Leaking bags must be discarded, as sterility cannot be guaranteed.

To open and sequentially mix the compartments, roll the bag with both hands, applying pressure on the seal separating the upper compartment (glucose) from the lower compartment (amino acids) (Fig. 2a). Then continue applying pressure until the seal separating the middle compartment (lipids) from the lower compartment opens (Fig. 2b).
After removing the aluminium closure (Fig. 3), compatible additives may be added through the medication addition port (Fig. 4).

Carefully mix the contents of the bag (Fig. 5) and visually inspect the mixture (Fig. 6). No signs of emulsion phase separation should be visible.
The mixture is a homogeneous oil-in-water emulsion, white and milky in appearance.
Preparation of the infusion
The emulsion must always be brought to room temperature before infusion.
Remove the aluminium film (Fig. 7) from the infusion port and connect the infusion set (Fig. 8). Use a non-vented infusion set or close the air vent if a vented set is used. Hang the bag on an IV pole (Fig. 9) and administer the infusion according to standard techniques.

For single use only. The container and any unused residues must be discarded after use. Do not reconnect a partially used container.
If filters are used, they must be lipid-permeable (pore size ≥1.2 µm).
Shelf life after removal of the protective overwrap and mixing of the bag contents
Chemical and physicochemical stability of the mixture of amino acids, glucose and fats has been demonstrated for 7 days at 2-8°C and for an additional 2 days at 25°C.
Shelf life after addition of compatible additives
From a microbiological standpoint, the product should be used immediately after addition of additives.
If the product is not used immediately after addition of additives, the user is responsible for the storage times and conditions during use.
The emulsion must be used immediately after opening the container.
Lipoflex, AA 56 / G 144 without electrolytes must not be mixed with other medicinal products unless compatibility has been documented. Compatibility data for various additives (e.g. electrolytes, trace elements, vitamins) and shelf-life data for such mixtures are available on request from the manufacturer.
Lipoflex, AA 56 / G 144 without electrolytes must not be administered simultaneously with blood through the same infusion set due to the risk of pseudoagglutination.
Duration of infusion of a single bag
The recommended infusion duration for one parenteral nutrition bag is up to 24 hours.