Lipofundin Mct/lct 10%

Leaflet attached to the packaging: information for the user

Lipofundin MCT/LCT 10% (50 mg/ml + 50 mg/ml) infusion emulsion

You should read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• You should consult a doctor or pharmacist if you have any further doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others.
• The medicine may harm another person, even if their symptoms are the same as yours.
• If any of the side effects get worse, or if you notice any not listed in the leaflet, you should tell your doctor, pharmacist, or nurse.

Table of contents of the leaflet:

• 1. What is Lipofundin MCT/LCT 10% and what is it used for
• 2. Important information before using Lipofundin MCT/LCT 10%
• 3. How to use Lipofundin MCT/LCT 10%
• 4. Possible side effects
• 5. How to store Lipofundin MCT/LCT 10%
• 6. Contents of the packaging and other information

1. What is Lipofundin MCT/LCT 10% and what is it used for

Lipofundin MCT/LCT 10% is an oil-in-water emulsion. The fats contained in Lipofundin MCT/LCT 10% provide the body with energy and essential fatty acids, which are necessary for growth and recovery.
Lipofundin MCT/LCT 10% is administered by infusion (intravenously) as a component of nutrition when oral or enteral nutrition is not possible.

2. Important information before using Lipofundin MCT/LCT 10%

When not to use Lipofundin MCT/LCT 10%:

Lipofundin MCT/LCT 10% should not be used in the following cases:

• high fat content in the blood (severe hyperlipidemia);
• severe blood coagulation disorders (severe coagulopathy, worsening bleeding disorder);
• severe liver failure;
• disrupted bile flow (intrahepatic cholestasis);
• blockage of blood vessels by blood clots or fat (acute thromboembolic disease, fat embolism);
• blood acidification (metabolic acidosis);
• life-threatening circulatory disorders that may occur in shock or collapse;
• unstable metabolism due to severe injury or surgery (post-traumatic syndrome), infections affecting the whole body (sepsis), or coma of unknown origin;
• severe heart attack or stroke;
• severe kidney failure without access to artificial kidney treatment;
• unbalanced fluid or electrolyte disorders, such as low water and electrolyte levels (hypotonic dehydration) or low potassium levels (hypokalemia) in the blood;
• severe heart failure (uncompensated heart failure);
• fluid accumulation in the lungs (acute pulmonary edema).

Warnings and precautions

Before starting to use Lipofundin MCT/LCT 10%, you should consult a doctor, pharmacist, or nurse.
During infusion, the fat level (triglyceride concentration in serum) should be regularly monitored. If the fat level in the blood is too high, the doctor may reduce the infusion rate or stop the infusion.
Before starting to use this medicine, fluid and electrolyte balance disorders, as well as acid-base balance disorders, should be corrected.
During the use of this medicine, fluid levels, blood electrolyte concentrations, and acid-base balance, as well as heart function, should be monitored. The doctor may decide to administer this medicine for a period of several weeks. In this case, liver function, coagulation factors, and blood cell count should be monitored.
Reactions to this medicine are extremely rare. If any allergic reactions occur, such as fever, chills, rash, or difficulty breathing, during the administration of this medicine, the infusion should be stopped immediately.
To prevent blood acidification (metabolic acidosis), carbohydrates and amino acids should be administered simultaneously with Lipofundin MCT/LCT 10%.
To ensure that parenteral nutrition is complete, carbohydrate and amino acid solutions should also be administered. Nursing staff may also take appropriate measures to ensure that the patient's body receives sufficient fluids, electrolytes, vitamins, and trace elements.

Elderly patients

In some cases, the ability to properly utilize fats may be impaired, particularly in elderly patients with concomitant diseases, such as heart or kidney disorders.

Patients with fat metabolism disorders

In some cases, the ability to properly utilize fats may be impaired. Therefore, you should inform your doctor if you have:

• diabetes;
• pancreatitis;
• liver or kidney function disorders (kidney or liver failure);
• blood poisoning (sepsis);
• reduced thyroid activity (hypothyroidism). In cases of impaired fat utilization, triglyceride levels in the blood should be closely monitored.

Children

In the case of children at risk of jaundice, triglyceride and bilirubin levels in the blood should be monitored. It may be necessary to modify the daily fat dose.
During infusion, this medicine should be protected from phototherapy light, as it may lead to the formation of potentially hazardous compounds (triglyceride hydroperoxides).
When used in children from premature babies to 2 years of age, the emulsion (and administration set) should be protected from light from preparation to infusion to the end of administration. Exposure of parenteral nutrition mixtures containing Lipofundin MCT/LCT 10% to light, especially after the addition of trace elements and/or vitamins, leads to the formation of hydroperoxides and other degradation products, which can be limited by protecting against light.

Other medicines and Lipofundin MCT/LCT 10%

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Lipofundin MCT/LCT 10% may interact with other medicines. You should tell your doctor if you are taking medicines that affect blood coagulation, in particular:

• heparin;
• coumarin derivatives, such as warfarin.

Pregnancy, breastfeeding, and fertility:

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should consult a doctor or pharmacist before using this medicine.
There is no exact data on the use of Lipofundin MCT/LCT 10% in pregnant women.
This medicine will only be given to pregnant women if the doctor considers it essential to save a life or prevent more serious harm.
Breastfeeding is not recommended if you are receiving parenteral nutrition.

Driving and using machines

Lipofundin MCT/LCT 10% is usually administered to bedridden patients in a hospital or clinic, which excludes driving and using machines.
Lipofundin MCT/LCT 10% contains less than 1 mmol/l (23 mg) of sodium per liter, which means it is essentially "sodium-free".

3. How to use Lipofundin MCT/LCT 10%

This medicine is administered as an intravenous infusion (drip), i.e., through an infusion set into a vein.
The doses given below are proposed values. The doctor will determine the required dose of the medicine and the duration of treatment for the individual patient.
Adults
The standard dose is 0.7 to 1.5 g of fat per kg of body weight per day. The maximum dose of 2.0 g of fat per kg of body weight per day should not be exceeded, which can be given in situations such as high energy requirements or fat burning (e.g., cancer patients).
In the following patient groups, the dose should not exceed 1.0 g per kg of body weight per day:

• long-term home parenteral nutrition (> 6 months);
• patients with short bowel syndrome. For a patient weighing 70 kg, the daily dose of 2.0 g per kg of body weight per day corresponds to a maximum daily dose of Lipofundin MCT/LCT 10% of 1400 ml.

Children
It may be beneficial to gradually increase the fat intake from 0.5 to 1.0 g per kg of body weight per day. This procedure will allow the doctor to monitor the increase in triglyceride levels in the blood and prevent excessive fat levels in the blood (hyperlipidemia).
Preterm infants, full-term newborns, infants, and young children
In preterm infants, the initial dose should be 0.5 to 1.0 g/kg/day and should be gradually increased by 0.5 to 1.0 g/kg/day to a maximum dose of 3 g/kg/day.
In infants and young children, the daily dose should not exceed 3 (max. 4) g/kg/day.
In this age group, the daily dose should be administered by continuous infusion over 24 hours.
Children and adolescents
The daily dose of fat should not exceed 2.0-3.0 g per kg of body weight.
When used in children from premature babies to 2 years of age, the emulsion (and administration set) should be protected from light from preparation to infusion to the end of administration (see section 2).
Infusion rate
The infusion rate should be as low as possible. The infusion rate during the first 15 minutes should not exceed 50% of the planned maximum infusion rate.
The patient should be closely monitored for the occurrence of side effects.
Maximum infusion rate:
Adults
Up to 0.15 g of fat per kg of body weight per hour.
This means that for a patient weighing 70 kg, the maximum infusion rate is 105 ml of Lipofundin MCT/LCT 10% per hour. The amount of fat is 10.5 g per hour in this case.
Preterm infants, full-term newborns, infants, and young children
Up to 0.17 g of fat per kg of body weight per hour.
Children and adolescents
Up to 0.13 g of fat per kg of body weight per hour.

Using a higher dose of Lipofundin MCT/LCT 10% than recommended

If too high a dose of Lipofundin MCT/LCT 10% is administered, it may lead to a significant increase in fat levels in the blood (hyperlipidemia), blood acidification (metabolic acidosis), or fat overload syndrome. For symptoms of fat overload syndrome, see section 4 "Possible side effects".
If too high a dose of Lipofundin MCT/LCT 10% is administered, the infusion should be stopped.
The infusion can be resumed only after the symptoms of overdose have subsided. The doctor may decide to adjust the daily dose. The doctor will decide on any additional treatment.

4. Possible side effects

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

The following side effects may be serious. If you experience any of the following side effects, you should immediately inform your doctor, who will stop the administration of the medicine:

Very rare (occurring in less than 1 in 10,000 patients):

• allergic reactions, such as skin reactions, shortness of breath, swelling of the lips, mouth, and throat, difficulty breathing;
• breathing difficulties (dyspnea);
• blue discoloration of the skin (cyanosis).

Other side effects:

Very rare (occurring in less than 1 in 10,000 patients):

• fat overload syndrome (see "Fat overload syndrome" below);
• increased tendency to blood coagulation (hypercoagulability);
• abnormally high fat levels in the blood (hyperlipidemia);
• abnormally high sugar levels in the blood (hyperglycemia);
• metabolic condition characterized by blood acidification (metabolic and ketonic acidosis);
• increase or decrease in blood pressure;
• dizziness;
• nausea, vomiting, loss of appetite;
• headache;
• hot flashes;
• redness of the skin (flushing);
• increased body temperature;
• sweating;
• feeling cold, chills;
• back, chest, bone, or lumbar pain.

Frequency not known (frequency cannot be estimated from available data)

• disrupted bile flow (cholestasis);
• decrease in white blood cell count (leukopenia);
• decrease in platelet count (thrombocytopenia).

Fat overload syndrome

In the case of an overdose of Lipofundin MCT/LCT 10%, "fat overload syndrome" may occur, which means that the body has problems utilizing fats.
The cause of impaired fat utilization may be a sudden change in health status (kidney problems or infection).
These symptoms are usually reversible if the infusion of the fat emulsion is stopped.
Fat overload syndrome is characterized by the following symptoms:

• high fat levels in the blood (hyperlipidemia);
• fever;
• fat accumulation in the liver and other organs (fatty infiltrations);
• enlargement of the liver (hepatomegaly), which may be accompanied by jaundice;
• enlargement of the spleen (splenomegaly);
• decrease in red blood cell count (anemia);
• decrease in white blood cell count (leukopenia);
• decrease in platelet count (thrombocytopenia);
• blood coagulation disorders;
• blood cell breakdown (hemolysis);
• increase in immature red blood cells (reticulocytosis);
• abnormal liver function test results;
• loss of consciousness.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lipofundin MCT/LCT 10%

Store in a place inaccessible and invisible to children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the given month.
Store at a temperature below 25°C. Protect from light, do not freeze. In case of accidental freezing, the product should be discarded.
The medicine can only be used if the container is undamaged, and the emulsion is homogeneous and milky white, without visible oil droplets.
The bottles are for single use only. Unused contents should be discarded.
When used in children from premature babies to 2 years of age, the emulsion (and administration set) should be protected from light from preparation to infusion to the end of administration (see section 2).

6. Contents of the packaging and other information

What does Lipofundin MCT/LCT 10% contain

The active substance content in 1000 ml of Lipofundin MCT/LCT 10% is:
Purified soybean oil
50.0 g
Medium-chain triglycerides
50.0 g
Necessary fatty acid composition
Linoleic acid:
24.0 - 29.0 g/l
α-linolenic acid:
2.5 – 5.5 g/l
Caloric value [kJ/l (kcal/l)]:
4330 (1035)
Theoretical osmolality [mOsm/l]
345
Acid-base titration (up to pH 7.4) [mmol/l] <0.5
pH
6.5 – 8.8
Other ingredients of the medicine are glycerol, egg lecithin, α-tocopherol, sodium oleate, and water for injections.

What does Lipofundin MCT/LCT 10% look like and what does the packaging contain

Lipofundin MCT/LCT 10% is a milky white emulsion. It is an infusion emulsion, which means it is administered through an infusion set.
The medicine is supplied in glass bottles closed with rubber stoppers, containing: 100ml, 250ml, or 500ml.
Not all pack sizes may be marketed.

Responsible entity and manufacturer

• B. Braun Melsungen AG Carl-Braun-Strasse 1 Postal address34212 Melsungen 34209 Melsungen, Germany Germany Phone +49-5661-71-0 Fax +49-5661-71-4567

Date of last update of the leaflet: 2019-12-17

Information intended only for healthcare professionals:
Additional special warnings and precautions for use
Combining incompatible substances may lead to emulsion breakage or precipitation of particles, which can significantly increase the risk of embolism.
In the case of high-fat fluids (e.g., Lipofundin MCT/LCT 20%), the ratio of emulsifier (phospholipids) to oil is lower than in emulsions with lower fat content.
Using such fluids ensures lower triglyceride, phospholipid, free fatty acid, and pathological lipoprotein X levels in the patient's serum. Therefore, it is recommended to use high-fat emulsions, such as Lipofundin MCT/LCT 20%.
Exposure to light of parenteral nutrition mixtures containing Lipofundin MCT/LCT 10%, especially after the addition of trace elements and/or vitamins, may have undesirable effects on the clinical response in newborns due to the formation of hydroperoxides and other degradation products. When used in children from premature babies to 2 years of age, Lipofundin MCT/LCT 10% should be protected from light from preparation to infusion to the end of administration. Exposure of such mixtures to light, especially after the addition of trace elements and/or vitamins, leads to the formation of hydroperoxides and other degradation products, which can be limited by protecting against light.
Effect on laboratory tests
Fats may distort the results of some diagnostic tests (such as bilirubin, lactate dehydrogenase, oxygen saturation), if they are not removed from the blood before sampling, which may take 4 to 6 hours.
Incompatibilities
Lipofundin MCT/LCT 10% cannot be used as a carrier solution for electrolyte concentrates or other medicinal products and cannot be mixed with other infusion solutions in an uncontrolled manner, as this does not guarantee the stability of the emulsion.
Special precautions for disposal and preparation of the medicinal product for use
Gently shake before use.
Before starting the infusion, the emulsion should be warmed to room temperature, but not using heaters (such as a stove or microwave).
When using filters, ensure they are fat-permeable.
Before starting the infusion of the fat emulsion simultaneously with other solutions through a "Y" connector or other infusion set, the compatibility of these solutions should be confirmed, particularly when solutions containing medicinal products are administered simultaneously. Special attention should be paid when solutions containing divalent ions (such as calcium or magnesium) are administered simultaneously.
When used in children from premature babies to 2 years of age, parenteral nutrition mixtures containing Lipofundin MCT/LCT 10% should be protected from light from preparation to infusion to the end of administration. Exposure of such mixtures to light, especially after the addition of trace elements and/or vitamins, leads to the formation of hydroperoxides and other degradation products, which can be limited by protecting against light.
Method of administration
Fat emulsions can be administered into peripheral or central veins and can be administered through peripheral or central veins as part of parenteral nutrition.
If a fat emulsion is administered simultaneously with amino acid or carbohydrate solutions, a short "Y" connector or three-way stopcock should be placed as close as possible to the infusion site.
The administration time of Lipofundin MCT/LCT 10% is usually 1-2 weeks. If further use of fat emulsion is indicated during parenteral nutrition, Lipofundin MCT/LCT 10% can be administered for a longer period, provided that proper monitoring is performed.
When used in children from premature babies to 2 years of age, the emulsion (and administration set) should be protected from light from preparation to infusion to the end of administration.