Lipofundin MCT/LCT 10% emulsion for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lipofundin MCT/LCT 10% emulsion for infusion

Soybean oil, refined; medium-chain triglycerides

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Lipofundin MCT/LCT 10% is and what it is used for
2. What you need to know 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 pack and other information

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

Lipofundin MCT/LCT 10% is an oil-in-water emulsion. The oils in Lipofundin MCT/LCT 10% provide energy and contain essential fatty acids, which are necessary for bodily functions and required by your body for growth and recovery.

Lipofundin MCT/LCT 10% is administered to you by intravenous infusion (drip into the vein) as part of a nutritional therapy because you are unable to eat properly or cannot be fed through a nasogastric tube.

2. What you need to know before using Lipofundin MCT/LCT 10%

Do not use Lipofundin MCT/LCT 10%

• If you are allergic to egg protein or soy protein, peanut or soy products, or to any of the ingredients of this medicine (listed in section 6).

Do not use Lipofundin MCT/LCT if you have any of the following conditions:

• severely elevated blood fat levels (severe hyperlipidemia)
• a disorder in which blood does not clot properly (severe coagulopathy, worsening hemorrhagic diathesis)
• severe liver failure
• impairment of bile flow (intrahepatic cholestasis)
• blockage of blood vessels by blood or fat clots (acute thromboembolic events, fat embolism)
• disorders in which the blood is too acidic (metabolic acidosis)
• potentially life-threatening circulatory problems, such as those occurring during collapse or shock
• unstable metabolism, for example due to severe trauma or surgical procedures (post-aggression syndrome), systemic infections involving the whole body (severe sepsis), or coma of unknown origin
• acute phase of heart attack (myocardial infarction) or stroke
• severe renal failure without dialysis treatment
• untreated disturbances in fluid or electrolyte balance, for example low levels of water and salt in the body (hypotonic dehydration) or low potassium levels (hypokalemia) in your blood
• severe heart failure (decompensated heart failure)
• fluid accumulation in the lungs (acute pulmonary edema)

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Lipofundin MCT/LCT.

During infusion, your doctor must regularly monitor the fat levels in your blood (serum triglycerides). If your blood fat levels rise too high, your doctor may reduce the infusion rate or stop the infusion.

Before receiving this medicine, your doctor must correct any existing disturbances in your body's fluid and electrolyte content, as well as any acid-base imbalances.

While you are receiving this solution, your doctor should monitor your fluid levels, blood electrolytes, acid-base balance, and cardiac function. Your doctor may consider it necessary for you to receive this solution for several weeks. In such cases, your liver function and blood coagulation function will be monitored, and blood counts (hemograms) should be performed.

Allergic reactions to this medicine are extremely rare. If you show signs of an allergic reaction while receiving this medicine—such as fever, chills, hives, or breathing difficulties—your doctor must stop the infusion immediately.

In addition to Lipofundin MCT/LCT, you may receive a carbohydrate solution and an amino acid solution to prevent metabolic conditions in which your blood becomes too acidic (metabolic acidosis).

To ensure your intravenous nutrition is complete, you may also receive carbohydrate and amino acid solutions. Nursing staff may also take measures to ensure your body's requirements for fluids, electrolytes, vitamins, and trace elements are met.

When used in children from premature birth up to 2 years of age, the emulsion (including administration sets) must be protected from light exposure from the time of preparation for infusion until the end of administration. Exposure of parenteral nutrition mixtures containing Lipofundin MCT/LCT 10% to light, especially after mixing with trace elements or vitamins, leads to the formation of peroxides and other degradation products, which can be minimized by protecting the product from light.

Elderly patients

In certain conditions, your ability to properly metabolize fats may be impaired. Your doctor will take into account that some of these conditions are frequently associated with advanced age, e.g., impaired cardiac or renal function.

Patients with lipid metabolism disorders

In certain conditions, your ability to properly metabolize fats may be impaired. Therefore, it is important that your doctor knows:

• if you have diabetes mellitus
• if you have inflammation of the pancreas (pancreatitis)
• if you have impaired liver or kidney function (renal failure, hepatic failure)
• if you have blood poisoning (sepsis)
• if you have reduced thyroid gland activity (hypothyroidism)

If your ability to properly metabolize fats is impaired, your doctor must closely monitor your blood fat levels (serum triglycerides).

Children

In infants at risk of jaundice, your doctor must monitor blood fat levels (serum triglycerides) and bilirubin levels. Your doctor may need to adjust the daily dose of fats.

During infusion, this solution must be protected from phototherapy light to reduce the formation of potentially harmful substances (triglyceride hydroperoxides).

Use of Lipofundin MCT/LCT 10% with other medicines

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

Lipofundin MCT/LCT may interact with certain medicines. Inform your doctor if you are taking or receiving specific medications to control blood clotting, such as:

• heparin
• coumarin derivatives, e.g., Warfarin

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

There are insufficient data on the use of Lipofundin MCT/LCT in pregnant women. If you are pregnant, you will receive this medicine only if your doctor considers it absolutely necessary for your recovery.

Breastfeeding is not recommended for women receiving parenteral nutrition.

Driving and using machines

Lipofundin MCT/LCT is typically administered to patients in a controlled setting (a hospital or clinic). This excludes driving and operating machinery.

Important information about some of the components of Lipofundin MCT/LCT 10%

This medicine contains less than 1 mmol of sodium (23 mg) per liter; hence, it is essentially "sodium-free."

3. How to use Lipofundina MCT/LCT 10%

This medicine is administered by intravenous infusion (drip), that is, through a small tube directly into a vein.

The following doses are indicative recommendations. Your doctor will decide how much of this medicine you need and how long you require treatment with this medicine.

Adults

A daily dose of 0.7–1.3 g of lipids per kg of body weight per day is recommended. In case of increased energy requirements, your doctor may administer up to 1.5 g per kg of body weight per day. Your energy requirements may be increased in conditions such as cancer or certain diseases.

In the following patient groups, intravenous lipid administration should not exceed 1 g per kg of body weight per day:

• Patients receiving long-term home treatment (>6 months)
• Patients with short bowel syndrome

For a patient weighing 70 kg, a daily dose of 1.5 g per kg of body weight per day corresponds to the maximum daily dose of 1,050 ml of Lipofundina MCT/LCT 10%.

Paediatric population

A gradual increase in lipids of 0.5–1 g per kg of body weight per day may be beneficial. This may help your doctor monitor the rise in plasma triglyceride levels and prevent excessively high lipid levels (hyperlipidaemia).

Premature infants, neonates and infants

A daily lipid dose exceeding 3 g (max. 4 g) per kg of body weight per day is not recommended.

In this age group, the daily lipid dose should be infused continuously over approximately 24 hours.

Children and adolescents

A daily lipid dose exceeding 2–3 g per kg of body weight per day is not recommended.

Infusion rate

The infusion should be administered at the lowest possible rate. During the first 15 minutes, the infusion rate should be 50% of the maximum infusion rate to be used. Your doctor should closely monitor you for the occurrence of adverse effects.

Maximum infusion rate

Adults

Up to 0.10 g of lipids per kg of body weight per hour.

For a patient weighing 70 kg, this corresponds to a maximum infusion rate of 70 ml per hour of Lipofundina MCT/LCT 10%. The amount of lipids administered is then 7 g per hour.

Premature infants, neonates and infants

Up to 0.17 g of lipids per kg of body weight per hour.

Children and adolescents

Up to 0.13 g of lipids per kg of body weight per hour.

When used in children from premature birth up to 2 years of age, the emulsion (including administration equipment) must be protected from exposure to light from the time of preparation for infusion until administration is complete (see section 2).

If you use more Lipofundina MCT/LCT 10% than you should

If you have received too much Lipofundina MCT/LCT, your fat levels may become abnormally elevated (hyperlipidaemia), your blood may become too acidic (metabolic acidosis), or you may develop a condition called "fat overload syndrome". For symptoms of fat overload syndrome, see section 4.

If these adverse effects occur during treatment, the infusion of Lipofundina MCT/LCT must be stopped. The infusion should not be restarted until you have recovered. Your doctor may need to adjust your daily fat doses. Your doctor will decide on any additional treatment required.

4. Possible adverse effects

Like all medicines, Lipofundin MCT/LCT may cause adverse effects, although not everyone experiences them.

The following adverse effects can be serious. If any of the following occur, inform your doctor immediately and stop administering this medicine:

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

• allergic reactions, e.g. skin reactions, difficulty breathing, swelling of the lips, mouth and throat, difficulty in breathing
• breathing problems (dyspnoea)
• bluish discoloration of the skin (cyanosis)

Other adverse effects:

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

• fat overload syndrome (see "fat overload syndrome" below)
• increased tendency of your blood to clot (hypercoagulability)
• abnormally high levels of fat in the blood (hyperlipidemia)
• abnormally high blood sugar levels (hyperglycaemia)
• metabolic conditions in which your blood becomes acidic (metabolic acidosis, ketoacidosis)
• decrease or increase in blood pressure
• drowsiness
• nausea, vomiting, loss of appetite
• headache
• flushing
• redness of the skin (erythema)
• high body temperature
• sweating
• feeling cold, chills
• back, bone, chest and lumbar pain

Not known (frequency cannot be estimated from available data)

• disturbance in bile flow (cholestasis)
• reduction in white blood cell count in blood (leucopenia)
• reduction in platelet count in blood (thrombocytopenia)

Fat overload syndrome

You may develop "fat overload syndrome" if you have received too much Lipofundin MCT/LCT or when your body has difficulty processing fats. Your body's ability to metabolize fats may be affected by a sudden change in your condition (due to kidney problems or 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 (hyperlipidemia)
• fever
• fat deposition in the liver or other organs (fatty infiltration)
• enlarged liver (hepatomegaly), which may be accompanied by jaundice
• enlarged spleen (splenomegaly)
• reduced red blood cell count (anaemia)
• reduced white blood cell count (leucopenia)
• reduced platelet count (thrombocytopenia)
• blood coagulation disorders
• fragmentation of blood cells (haemolysis)
• increased number of immature red blood cells (reticulocytosis)
• abnormal liver function tests
• loss of consciousness

Reporting of adverse effects

If you experience any adverse event, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es

5. Storage of Lipofundina MCT/LCT 10%

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 the month indicated.

Do not store above 25°C. Do not freeze. The product should be discarded if it has been frozen.

Store the vials in the outer packaging to protect them from light.

When used in children from premature birth up to 2 years of age, the emulsion (including the administration sets) must be protected from exposure to light from the time of preparation for infusion until the end of administration (see section

6. Contents of the container and other information

Composition of Lipofundin MCT/LCT 10%

The active substances in each 1,000 ml of Lipofundin MCT/LCT 10% are:

Soybean oil, refined 50.0 g

Medium-chain triglycerides (MCT) 50.0 g

Content of essential fatty acids in 1,000 ml:

Linoleic acid 24.0–29.0 g/l

α-Linolenic acid 2.5–5.5 g/l

The other components are glycerol, egg phospholipids for injectable preparations, all-rac-α-tocopherol, sodium oleate (for pH adjustment), and water for injectable preparations.

Appearance of the product and contents of the container

Lipofundin MCT/LCT is a milky white emulsion. It is an emulsion for infusion, meaning it is administered through a small tube inserted into a vein.

It is available in glass vials sealed with rubber stoppers containing:

? 100 ml, available in packages of 1 x 100 ml

? 250 ml, available in packages of 1 x 250 ml

? 500 ml, available in packages of 1 x 500 ml

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Manufacturer:

• Braun Melsungen AG

Carl-Braun-Strasse 1

D-34212 Melsungen, Germany

Telephone: +49-5661-71-3383

Fax: +49-5661-75-3383

Date of the most recent revision of this leaflet: October 2022

This information is intended for healthcare professionals only:

Additional special warnings and precautions for use

Mixing with incompatible substances may lead to emulsion separation or particle precipitation, which poses a high risk of embolism.

In solutions with higher lipid concentrations (e.g., Lipofundin MCT/LCT 20%), the ratio of emulsifier (phospholipid) to oil is lower than in less concentrated lipid emulsions. This ensures a lower and favorable plasma concentration of triglycerides, phospholipids, free fatty acids, and pathological lipoprotein-X in the patient's blood. Therefore, higher-concentration lipid emulsions such as Lipofundin MCT/LCT 20% should be preferred over less concentrated lipid emulsions.

Exposure to light of intravenous parenteral nutrition mixtures, especially after mixing with trace elements or vitamins, may adversely affect clinical outcomes in newborns due to the formation of peroxides and other degradation products. When used in children from premature birth up to 2 years of age, Lipofundin MCT/LCT 10% must be protected from light from the time of preparation for infusion until the end of administration.

Interference with laboratory tests

Lipids may interfere with certain laboratory tests (such as bilirubin, lactate dehydrogenase, oxygen saturation) when blood samples are taken before lipids have been cleared from the bloodstream. This clearance may take between 4 and 6 hours.

Incompatibilities

Lipofundin MCT/LCT must not be used as a carrier solution for concentrated electrolytes or other pharmaceutical products, nor should the emulsion be mixed with other infusion solutions in an uncontrolled manner, as adequate emulsion stability would no longer be guaranteed.

Special precautions for disposal and other handling

Shake gently before use.

The emulsion must be brought to room temperature naturally prior to infusion; the product must not be placed in a heating device (such as an oven or microwave).

If filters are used, they must be lipid-permeable.

Prior to infusing a lipid emulsion together with other solutions via a Y-connector or bypass set, compatibility of these fluids must be verified, especially when administered with vehicle solutions to which drugs have been added. Particular care must be taken when simultaneously infusing solutions containing divalent electrolytes (such as calcium or magnesium).

When the product is packaged in flexible bags, the air outlet of the administration set must be closed.

When used in children from premature birth up to 2 years of age, parenteral nutrition mixtures containing Lipofundin MCT/LCT 10% must be protected from exposure to light from the time of preparation for infusion until the end of administration. Exposure of such mixtures to light, especially after mixing with trace elements or vitamins, generates peroxides and other degradation products, which can be minimized by protecting the product from light exposure.

Administration method

Lipid emulsions are suitable for peripheral intravenous administration and may also be given separately through peripheral veins as part of complete parenteral nutrition.

If lipid emulsions are administered simultaneously with amino acid and carbohydrate solutions, the Y-connector or side port should be placed as close as possible to the patient.

The usual duration of administration of Lipofundin MCT/LCT 10% is between 1 and 2 weeks. If continued parenteral nutrition with lipid emulsions is indicated, Lipofundin MCT/LCT 10% may be administered for longer periods provided adequate monitoring is implemented.

When used in children from premature birth up to 2 years of age, the emulsion (including the administration set) must be protected from light exposure after preparation for infusion until administration is complete.