Lipofundin MCT

Package leaflet: Information for the user

LIPOFUNDIN MCT 5g + 5g/100ml infusion emulsion

Soybean oil, refined; medium-chain triglycerides
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, consult 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 effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What LIPOFUNDIN MCT is and what it is used for

LIPOFUNDIN MCT is an oil-in-water emulsion. The oils contained in LIPOFUNDIN MCT
provide energy and contain essential fatty acids required by the body.
LIPOFUNDIN MCT is administered intravenously (into a vein) as part of an artificial
nutrition regimen because you are unable to eat adequately or cannot be fed
through a feeding tube.

2. What you need to know before using LIPOFUNDIN MCT

Do not use LIPOFUNDIN MCT

• if you are allergic to egg or soy proteins, or to soy- or peanut-based products, or to any of the other ingredients of this medicine (listed in section 6)

Do not use LIPOFUNDIN MCT if you have any of the following conditions:

• severe increase in blood fat levels (severe hyperlipidemia)

• a disease causing blood not to clot properly (severe coagulopathy)

• severe liver failure (severe hepatic insufficiency)

• disorders of bile flow (intrahepatic cholestasis)

• blockage of a blood vessel due to blood clots or fat (acute thromboembolic events, lipid embolism)

• a constitutional tendency to bleeding (aggravating hemorrhagic diathesis)

• conditions involving excessive acid levels in the blood (metabolic acidosis)

• potentially life-threatening circulatory disorders, such as those occurring in case of collapse or shock

• unstable metabolism, for example due to severe trauma or surgery (post-aggression syndrome), systemic infections (severe sepsis) or coma of unknown origin

• acute myocardial infarction (heart attack) or acute stroke

• severe kidney failure (severe renal insufficiency) without dialysis

• untreated disturbances in fluid, electrolyte or acid-base balance, for example low levels of fluids and salts in the body (hypotonic dehydration) or low potassium levels in the blood (hypokalemia), or excess fluid in the body (see "Warnings and precautions")

• severe heart failure (decompensated cardiac insufficiency)

• fluid accumulation in the lungs (acute pulmonary edema)

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using LIPOFUNDIN MCT.
During the infusion, your doctor must regularly monitor your blood fat levels (serum triglycerides). If fat levels in your blood rise excessively, your doctor may reduce the infusion rate or stop the infusion.
Before this medicine is administered, your doctor must correct any disturbances in fluid and electrolyte levels and acid-base balance.
While you are receiving this solution, your doctor must monitor your body weight, blood levels of fluids and electrolytes, acid-base balance, and cardiac function. Your doctor may consider it necessary to administer this solution for several weeks. In such cases, liver function and blood coagulation must be monitored, and blood cell counts must be performed.
Allergic reactions to this medicine are extremely rare. If you show signs of an allergic reaction, such as fever, tremor, skin rash, or breathing difficulties during administration of this medicine, your doctor must stop the infusion immediately.
In addition to LIPOFUNDIN MCT, you may receive carbohydrate and amino acid solutions to prevent a metabolic condition in which acid levels in the blood increase (metabolic acidosis).
To complete parenteral nutrition, you may also receive carbohydrate and amino acid solutions, fluids, electrolytes, vitamins, and trace elements.
Mixing with incompatible substances may cause emulsion degradation or particle precipitation, both of which pose a high risk of embolism.

Elderly patients
In certain situations, the ability to properly metabolize fats may be impaired. Your doctor should be aware that some of these conditions are often associated with advanced age, such as impaired heart or kidney function.

Patients with impaired lipid metabolism
In certain situations, the ability to properly metabolize fats may be impaired. It is therefore important that your doctor is informed:

• if you have diabetes mellitus
• if you have inflammation of the pancreas (pancreatitis)
• if you have impaired liver or kidney function (renal insufficiency, impaired liver function)
• if you have blood poisoning (sepsis)
• if you have reduced thyroid activity (hypothyroidism)
• if you have certain lung diseases
  If your ability to properly metabolize fats is impaired, your doctor must carefully monitor your blood fat levels (serum triglycerides).

Children
In infants at risk of jaundice, the doctor must monitor blood levels of fats (serum triglycerides) and bilirubin. The doctor may need to adjust the daily fat dose or the rate of administration.
During infusion, this solution must be protected from light during phototherapy to reduce the formation of potentially harmful substances (triglyceride hydroperoxides).
When used in preterm neonates and children up to 2 years of age, after preparation for infusion, the emulsion (including administration sets) must be protected from light exposure until administration is complete. Exposure of parenteral nutrition mixtures containing LIPOFUNDIN MCT to light, especially after addition of trace elements and/or vitamins, generates peroxides and other degradation products, which can be minimized by protecting from light.

Other medicines and LIPOFUNDIN MCT
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
LIPOFUNDIN MCT may interact with other medicines. Inform your doctor if you are taking or receiving certain medicines affecting blood coagulation, such as:

• heparin
• coumarin derivatives, for example warfarin

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.
There are no data available on the use of LIPOFUNDIN MCT in pregnant women.
You will be given this medicine during pregnancy only if your doctor considers it essential for your treatment. Breastfeeding is not recommended for mothers undergoing parenteral nutrition.

Driving and using machines
LIPOFUNDIN MCT is generally administered to immobile patients in a controlled setting (hospital or clinic). LIPOFUNDIN MCT does not affect the ability to drive or operate machinery.

Important information about some excipients in LIPOFUNDIN MCT
This medicine contains less than 1 mmol of sodium (23 mg) per liter, i.e., it is practically "sodium-free".

3. How to use LIPOFUNDIN MCT

This medicinal product is administered intravenously (into a vein).
Your doctor will determine the dose and duration of treatment according to your individual needs.
When used in preterm neonates and children up to 2 years of age, after preparation for infusion the emulsion (including the administration sets) must be protected from exposure to light until administration is complete (see section 2).
If you receive more LIPOFUNDIN MCT than you should
If you have received an excessive amount of LIPOFUNDIN MCT, you may develop high levels of fat in the blood (hyperlipidemia), an increase in acid levels (metabolic acidosis), or you may experience the so-called "fat overload syndrome".
For symptoms of fat overload syndrome, see section 4 "Possible side effects".
If you have received too much LIPOFUNDIN MCT, the infusion will be stopped. The infusion will not be restarted until you have recovered. Your doctor may adjust your daily fat dose as needed. Your doctor will decide whether additional treatment is required.

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, who will stop administration of this medicine:
Very rare (may affect up to 1 in 10,000 people)

• allergic reactions, for example skin reactions, shortness of breath, swelling of the lips, tongue and throat, difficulty breathing
• breathing problems (dyspnoea)
• bluish skin (cyanosis)

Other side effects
Very rare (may affect up to 1 in 10,000 people)

• fat overload syndrome (for fat overload syndrome see below)
• increased tendency of blood to clot (hypercoagulability)
• excessively high levels of fats in the blood (hyperlipidaemia); for fat overload syndrome see below)
• excessively high blood sugar levels (hyperglycaemia)
• metabolic conditions in which the amount of acid in the blood increases (metabolic acidosis, ketoacidosis)
• decrease or increase in blood pressure
• drowsiness
• nausea, vomiting, loss of appetite
• headache
• hot flushes
• skin redness (erythema)
• elevated body temperature
• sweating
• feeling cold, chills
• back, bone, chest and lower back pain

Not known (frequency cannot be estimated from available data)

• impaired bile flow (cholestasis)
• reduced number of white blood cells (leucopenia)
• reduced number of platelets (thrombocytopenia)

Fat overload syndrome
You may develop a "fat overload syndrome" if you have received an excessive amount of LIPOFUNDIN MCT or if your body has difficulty using fats. Your body's ability to use fats may be affected by a sudden change in your condition (for example, due to kidney problems or an infection). Symptoms are usually reversible if the infusion is stopped. Fat overload syndrome is characterised by the following symptoms:

• high levels of fat in the blood (hyperlipidaemia)
• fever
• fat deposition in the liver or other organs (lipid infiltration)
• enlargement of the liver (hepatomegaly), sometimes accompanied by jaundice
• enlargement of the spleen (splenomegaly)
• reduced number of red blood cells in the blood (anaemia)
• reduced number of white blood cells in the blood (leucopenia)
• reduced number of platelets in the blood (thrombocytopenia)
• disturbances in the blood's ability to clot
• breakdown of blood cells (haemolysis)
• increase in immature red blood cells (reticulocytosis)
• abnormalities in blood tests measuring liver function
• loss of consciousness
  If adverse reactions occur, the infusion of LIPOFUNDIN MCT must be stopped or, if necessary, continued at a reduced dosage.

Reporting of side effects
If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, talk to your doctor, nurse or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store LIPOFUNDIN MCT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of that month.
Do not store above 25°C. Do not freeze. Products which have been frozen must be discarded.
Keep the vials in the outer packaging to protect the medicine from light.
Use only if the vial is intact and if the medicine is a homogeneous milky white emulsion, without visible oil droplets.
The vials are for single use only. After infusion, any unused emulsion and the container must be discarded.
When used in preterm neonates and children up to 2 years of age, after preparation for infusion the emulsion (including administration sets) must be protected from exposure to light until administration is complete (see section 2).

6. Package contents and other information

What LIPOFUNDIN MCT contains
The active substances in 1000 ml of LIPOFUNDIN MCT are:
Refined soybean oil 50.0 g
Medium-chain triglycerides (MCT) 50.0 g
Content of essential fatty acids:
linoleic acid 24.0 – 29.0 g/l
α-linolenic acid 2.5 – 5.5 g/l
Energy value [kJ/l (kcal/l)] 4330 (1035)
Theoretical osmolarity [mOsm/l] 345
Acidity or alkalinity (titration to pH 7.4) [mmol/l] <0.5
pH 6.0–8.8
The other components are glycerol, egg phospholipids for injection, α-tocopherol, sodium oleate and water
for injectable preparations.

Description of the appearance of LIPOFUNDIN MCT and contents of the pack
LIPOFUNDIN MCT is a white, milky emulsion. It is an infusion emulsion, meaning it is administered through a tube inserted into a vein.
It is supplied in glass vials closed with rubber stoppers and containing:

• 100 ml, available in packs of 10 x 100 ml
• 250 ml, available in packs of 10 x 250 ml
• 500 ml, available in packs of 10 x 500 ml

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
B. Braun Melsungen AG
Carl-Braun-Straße 1 Postal address
34212 Melsungen, Germany 34209 Melsungen, Germany
Telephone: +49-5661-71-0
Fax: +49-5661-71-4567

The following information is intended exclusively for physicians or healthcare professionals:

Special warnings and precautions for use
Mixing with incompatible substances may cause emulsion breakdown or particle precipitation, both of which carry a high risk of embolism.
In solutions with higher lipid concentrations (e.g., LIPOFUNDIN MCT 10g + 10g/100ml), the ratio between emulsifier (phospholipid) and oil is lower compared to less concentrated lipid emulsions. This ensures a more favorable lower plasma concentration of triglycerides, phospholipids, free fatty acids and pathological lipoprotein X in patients' blood. Therefore, more concentrated lipid emulsions such as LIPOFUNDIN MCT 10g + 10g/100ml are preferred over less concentrated lipid emulsions.
Exposure to light of parenteral nutrition mixtures for intravenous use, especially after addition of trace elements and/or vitamins, may have adverse effects on clinical outcomes in neonates due to the formation of peroxides and other degradation products. When used in preterm neonates and children up to 2 years of age, after preparation for infusion, LIPOFUNDIN MCT must be protected from light until administration is complete.

Interference with laboratory tests
Lipids may interfere with certain laboratory tests (such as bilirubin, lactate dehydrogenase, oxygen saturation) if blood samples are taken before lipids have been cleared from the bloodstream, which may take 4–6 hours.

Incompatibilities
LIPOFUNDIN MCT must not be used as a carrier solution for concentrated electrolytes or other medicinal products, and the emulsion must not be mixed with other infusion solutions in an uncontrolled manner, as adequate emulsion stability can no longer be guaranteed.

Special precautions for disposal and handling
Shake gently before use.
Prior to infusion, the emulsion must be brought to room temperature without placing the medicinal product in a heating device (oven or microwave).
If filters are used, they must be lipid-permeable.
Before infusing a lipid emulsion together with other solutions via a Y-connector or bypass set, compatibility of these solutions must be verified, especially when concomitantly administering carrier solutions to which medicinal products have been added. Particular caution is required when co-infusing solutions containing divalent electrolytes (such as calcium or magnesium).
When using a product packed in flexible bags, the vent of the administration set must be closed.
When used in preterm neonates and children up to 2 years of age, after preparation for infusion, mixtures containing LIPOFUNDIN MCT must be protected from exposure to light until administration is complete. Exposure of such mixtures to light, especially after addition of trace elements and/or vitamins, generates peroxides and other degradation products, which can be reduced by protecting from light exposure.

Dosage and method of administration
Adults
The recommended dose is 0.7 – 1.5 g/kg body weight per day.
The maximum daily dose is 2.0 g/kg body weight.
In case of long-term home treatment (> 6 months) or short bowel syndrome, the maximum daily dose is 1.0 g/kg body weight per day.

Children
In children, the daily lipid dose should be infused continuously over approximately 24 hours.
When used in preterm neonates and children up to 2 years of age, after preparation for infusion, the emulsion (including administration sets) must be protected from exposure to light until administration is complete.

Maximum daily dose

Infusion rate
The infusion rate should be as slow as possible. The infusion rate to be used during the
first 15 minutes of infusion must be only 50% of the maximum infusion rate.
The patient must be continuously monitored for the occurrence of adverse reactions.
Maximum infusion rate

Administration method
Intravenous infusion.
Fat emulsions may be administered via peripheral vein and by total parenteral nutrition into a peripheral vein.
The Y-connector or bypass must be placed as close as possible to the patient when lipid emulsions are administered together with amino acid and carbohydrate solutions.
The administration duration of LIPOFUNDIN MCT 5g + 5g/100ml within the context of total parenteral nutrition is generally 1–2 weeks. If long-term parenteral nutrition with lipid emulsions is additionally indicated, LIPOFUNDIN MCT 5g + 5g/100ml may be administered for much longer periods, provided adequate monitoring is ensured.

Package leaflet: Information for the user

LIPOFUNDIN MCT 10g + 10g/100ml emulsion for infusion

Soybean oil, refined; medium-chain triglycerides
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 others, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What LIPOFUNDIN MCT is and what it is used for

LIPOFUNDIN MCT is an oil-in-water emulsion. The oils contained in LIPOFUNDIN MCT
provide energy and contain essential fatty acids required by the body.
LIPOFUNDIN MCT is administered to you intravenously (into a vein) as part of an artificial
nutrition regimen because you are unable to eat adequately or cannot be fed
through a tube.

2. What you need to know before using LIPOFUNDIN MCT

Do not use LIPOFUNDIN MCT

• if you are allergic to egg or soybean proteins, soy- or peanut-based products, or to any of the other ingredients of this medicine (listed in section 6)

Do not use LIPOFUNDIN MCT if you have any of the following conditions:

• severe increase in blood fat levels (severe hyperlipidemia)

• a disease causing blood to not clot properly (severe coagulopathy)

• severe liver failure (severe hepatic insufficiency)

• disorders of bile flow (intrahepatic cholestasis)

• blockage of a blood vessel by blood clots or fat (acute thromboembolic events, lipid embolism)

• a constitutional predisposition to bleeding (worsening hemorrhagic diathesis)

• conditions involving excessive acid levels in the blood (metabolic acidosis)

• potentially life-threatening circulatory disorders, such as those occurring during collapse or shock

• unstable metabolism, for example due to severe trauma or surgery (post-aggression syndrome), systemic infections (severe sepsis), or coma of unknown origin

• acute myocardial infarction (heart attack) or acute stroke

• severe kidney failure (severe renal insufficiency) without dialysis

• untreated disturbances in fluid or electrolyte balance, or acid-base balance, for example low body water and salt content (hypotonic dehydration) or low potassium levels in the blood (hypokalemia), or fluid overload in the body (see "Warnings and precautions")

• severe heart failure (decompensated cardiac insufficiency)

• fluid accumulation in the lungs (acute pulmonary edema)

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using LIPOFUNDIN MCT.
During infusion, your doctor must regularly monitor the level of fats in your blood (serum triglycerides). If blood fat levels rise excessively, your doctor may reduce the infusion rate or stop the infusion.
Before administration of this medicine, your doctor must correct any disturbances in fluid and electrolyte balance and acid-base equilibrium.
While receiving this solution, your doctor must monitor your body weight, fluid status, blood electrolyte levels, acid-base balance, and cardiac function. Your doctor may consider it necessary to administer this solution for several weeks. In such cases, liver function, blood coagulation, and blood cell counts must be monitored.
Allergic reactions to this medicine are extremely rare. If you show signs of an allergic reaction, such as fever, trembling, skin rash, or breathing difficulties during administration of this medicine, your doctor must immediately stop the infusion.
In addition to LIPOFUNDIN MCT, you may receive carbohydrate and amino acid solutions to prevent a metabolic condition in which acid levels increase in the blood (metabolic acidosis).
To complete parenteral nutrition, you may also receive carbohydrate solutions, amino acid solutions, fluids, electrolytes, vitamins, and trace elements.
Mixing with incompatible substances may cause emulsion breakdown or particle precipitation, both of which pose a high risk of embolism.

Elderly patients
In certain situations, the ability to properly metabolize fats may be impaired. Your doctor should be aware that some of these conditions are often associated with advanced age, such as impaired heart or kidney function.

Patients with impaired lipid metabolism
In certain situations, the ability to properly metabolize fats may be impaired. It is therefore important that your doctor is informed:

• if you have diabetes mellitus
• if you have inflammation of the pancreas (pancreatitis)
• if you have impaired liver or kidney function (renal insufficiency, impaired liver function)
• if you have blood poisoning (sepsis)
• if you have reduced thyroid activity (hypothyroidism)
• if you have certain lung diseases
  If your ability to properly metabolize fats is impaired, your doctor must carefully monitor your blood fat levels (serum triglycerides).

Children
In infants at risk of jaundice, the doctor must monitor blood levels of fats (serum triglycerides) and bilirubin. The doctor may need to adjust the daily fat dose or the infusion rate.
During infusion, this solution must be protected from light during phototherapy to reduce the formation of potentially harmful substances (triglyceride hydroperoxides).
When used in preterm neonates and children up to 2 years of age, after preparation for infusion, the emulsion (including administration sets) must be protected from light exposure until administration is complete. Exposure of parenteral nutrition mixtures containing LIPOFUNDIN MCT to light, especially after addition of trace elements and/or vitamins, generates peroxides and other degradation products, which can be minimized by protection from light.

Other medicines and LIPOFUNDIN MCT
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
LIPOFUNDIN MCT may interact with other medicines. Inform your doctor if you are taking or receiving certain medications used to control blood clotting, such as:

• heparin
• coumarin derivatives, for example warfarin

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
There are no data available on the use of LIPOFUNDIN MCT in pregnant women.
You will be given this medicine during pregnancy only if your doctor considers it essential for your treatment. Breastfeeding is not recommended for mothers undergoing parenteral nutrition.

Driving and use of machines
Generally, LIPOFUNDIN MCT is administered to immobile patients in a controlled setting (hospital or clinic). LIPOFUNDIN MCT does not affect the ability to drive or operate machinery.

Important information about some excipients in LIPOFUNDIN MCT
This medicine contains less than 1 mmol of sodium (23 mg) per liter, i.e., it is practically "sodium-free".

3. How to use LIPOFUNDIN MCT

This medicinal product is administered intravenously (into a vein).
The doctor will determine the dose and duration of treatment according to your individual needs.
When used in preterm neonates and children up to 2 years of age, the emulsion (including the administration sets) must be protected from light exposure from the time of infusion preparation until administration is complete (see section 2).
If you receive more LIPOFUNDIN MCT than you should
If you have received an excessive amount of LIPOFUNDIN MCT, you may develop high levels of fat in the blood (hyperlipidemia), an increased level of acids (metabolic acidosis), or you may experience the so-called "fat overload syndrome".
For symptoms of fat overload syndrome, see section 4 "Possible side effects".
If you have received too much LIPOFUNDIN MCT, the infusion will be stopped. The infusion will not be restarted until you have recovered. The doctor may adjust your daily fat dose as needed. The doctor will decide whether additional treatment is required.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following side effects can be serious. If you experience any of the following side effects,
tell your doctor immediately, who will stop administration of this medicine:
Very rare (may affect up to 1 in 10,000)

• allergic reactions, for example skin reactions, shortness of breath, swelling of the lips, tongue and throat, difficulty breathing
• breathing problems (dyspnoea)
• bluish skin (cyanosis)

Other side effects
Very rare (may affect up to 1 in 10,000)

• fat overload syndrome (see "Fat overload syndrome" below)

• increased tendency of the blood to clot (hypercoagulability)

• excessively high levels of fats in the blood (hyperlipidaemia); for fat overload syndrome see below)

• excessively high blood sugar levels (hyperglycaemia)

• metabolic conditions in which the amount of acid in the blood increases (metabolic acidosis, ketoacidosis)

• decrease or increase in blood pressure

• drowsiness

• nausea, vomiting, loss of appetite

• headache

• hot flushes

• skin redness (erythema)

• elevated body temperature

• sweating

• feeling cold, chills

• back, bone, chest and lower back pain
  Frequency not known (frequency cannot be estimated from available data)

• impaired bile flow (cholestasis)

• reduced number of white blood cells (leucopenia)

• reduced number of platelets (thrombocytopenia)

Fat overload syndrome
You may develop a "fat overload syndrome" if you have received an excessive amount of LIPOFUNDIN MCT or if your body has difficulty using fats. Your body's ability to use fats may be affected by a sudden change in your condition (for example, due to kidney problems or an infection). Symptoms are usually reversible if the infusion is stopped. Fat overload syndrome is characterised by the following symptoms:

• high levels of fats in the blood (hyperlipidaemia)
• fever
• fat deposition in the liver or other organs (lipid infiltration)
• enlargement of the liver (hepatomegaly), sometimes accompanied by jaundice
• enlargement of the spleen (splenomegaly)
• reduced number of red blood cells in the blood (anaemia)
• reduced number of white blood cells in the blood (leucopenia)
• reduced number of platelets in the blood (thrombocytopenia)
• disturbances in the blood's ability to clot
• breakdown of blood cells (haemolysis)
• increased number of immature red blood cells (reticulocytosis)
• abnormalities in tests measuring liver function
• loss of consciousness

If adverse reactions occur, the infusion of LIPOFUNDIN MCT must be stopped or, if necessary, continued at a reduced dose.

Reporting of side effects
If any of the side effects worsen, or if you notice any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store LIPOFUNDIN MCT 10g + 10g/100ml

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of that month.
Do not store above 25°C. Do not freeze. Products that have been frozen must be discarded.
Keep the vials in the outer packaging to protect the medicine from light.
Use only if the vial is intact and if the medicine is homogeneous, milky white, and free from visible oil droplets.
The vials are for single use only. After infusion, any remaining emulsion and the container must be discarded.
When used in preterm neonates and children up to 2 years of age, the emulsion (including administration sets) must be protected from light exposure from the time of preparation until completion of administration (see section 2).

6. Package contents and other information

What LIPOFUNDIN MCT contains
The active substances in 1,000 ml of LIPOFUNDIN MCT are:
Soybean oil, refined 100.0 g
Medium-chain triglycerides (MCT) 100.0 g
Essential fatty acid content
Linoleic acid 48.0 – 58.0 g/l
α-Linolenic acid 5.0 – 11.0 g/l
Energy value [kJ/l (kcal/l)] 8095 (1935)
Theoretical osmolarity [mOsm/l] 380
Acidity or alkalinity (titration to pH 7.4) [mmol/l] < 0.5
pH 6.0–8.5
The other components are glycerol, egg phospholipids for injection, \α-tocopherol, sodium oleate and water for injections.

Description of the appearance of LIPOFUNDIN MCT and package contents
LIPOFUNDIN MCT is a white, milky emulsion. It is an emulsion for infusion, i.e. administered through a tube inserted into a vein.
It is supplied in glass bottles closed with rubber stoppers and containing:

• 100 ml, available in packs of 10 x 100 ml
• 250 ml, available in packs of 10 x 250 ml
• 500 ml, available in packs of 10 x 500 ml
• 1,000 ml, available in packs of 6 x 1,000 ml
  Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
B. Braun Melsungen AG
Carl-Braun-Straße 1 Postal address
34212 Melsungen, Germany 34209 Melsungen, Germany
Telephone: +49-5661-71-0
Fax: +49-5661-71-4567

The following information is intended exclusively for physicians or healthcare professionals:

Special warnings and precautions for use
Mixing with incompatible substances may cause degradation of the emulsion or precipitation of particles, both of which carry a high risk of embolism.
In solutions with higher lipid concentrations (e.g., LIPOFUNDIN MCT 10g + 10g/100ml), the ratio between emulsifier (phospholipid) and oil is lower compared to less concentrated lipid emulsions. This ensures a more favorably low plasma concentration of triglycerides, phospholipids, free fatty acids and pathological lipoprotein X in patients' blood. Therefore, more concentrated lipid emulsions such as LIPOFUNDIN MCT 10g + 10g/100ml are preferred over less concentrated lipid emulsions.
Exposure to light of parenteral nutrition mixtures for intravenous use, especially after addition of trace elements and/or vitamins, may have adverse effects on clinical outcomes in neonates due to the formation of peroxides and other degradation products. When used in preterm neonates and children up to 2 years of age, after preparation for infusion, LIPOFUNDIN MCT must be protected from ambient light until completion of administration.

Interference with laboratory tests
Lipids may interfere with certain laboratory tests (such as bilirubin, lactate dehydrogenase, oxygen saturation) if blood samples are taken before lipids have been cleared from the bloodstream, which may take 4–6 hours.

Incompatibilities
LIPOFUNDIN MCT must not be used as a carrier solution for concentrated electrolytes or other medicinal products, and the emulsion must not be mixed with other infusion solutions in an uncontrolled manner, as adequate emulsion stability can no longer be guaranteed.

Special precautions for disposal and handling
Shake gently before use.
Prior to infusion, the emulsion should be brought to room temperature without placing the medicinal product in a heating device (oven or microwave).
If filters are used, they must be lipid-permeable.
Before infusing a lipid emulsion together with other solutions via a Y-connector or bypass set, compatibility of these solutions must be verified, especially when co-administering carrier solutions to which medicinal products have been added. Particular caution is required when co-infusing solutions containing bivalent electrolytes (such as calcium or magnesium).
When using a product packaged in flexible bags, the vent on the administration set must be closed.
When used in preterm neonates and children up to 2 years of age, after preparation for infusion, mixtures containing LIPOFUNDIN MCT must be protected from exposure to light until completion of administration. Exposure of such mixtures to light, particularly after addition of trace elements and/or vitamins, generates peroxides and other degradation products, which can be reduced by protecting from light exposure.

Dosage and method of administration
Adults
The recommended dose is 0.7 – 1.5 g/kg body weight per day.
The maximum daily dose is 2.0 g/kg body weight.
In case of long-term home treatment (> 6 months) or short bowel syndrome, the maximum daily dose is 1.0 g/kg body weight per day.

Children
In children, the daily dose of lipids should be infused continuously over approximately 24 hours.
When used in preterm neonates and children up to 2 years of age, after preparation for infusion, the emulsion (including administration sets) must be protected from exposure to light until completion of administration.

Maximum daily dose

Infusion rate
The infusion rate should be as slow as possible. The infusion rate to be used during the
first 15 minutes of infusion must be only 50% of the maximum infusion rate.
The patient must be continuously monitored for the occurrence of adverse reactions.
Maximum infusion rate

Administration method
Intravenous infusion.
Fat emulsions may be administered via peripheral vein and by total parenteral nutrition into a peripheral vein.
The Y-connector or bypass must be placed as close as possible to the patient when lipid emulsions are administered together with amino acid and carbohydrate solutions.
The duration of administration of LIPOFUNDIN MCT within the context of total parenteral nutrition is generally 1–2 weeks. If parenteral nutrition with lipid emulsions is further indicated, LIPOFUNDIN MCT may be administered for much longer periods, provided adequate monitoring is ensured.