LIPOFUNDINA 20% EMULSION FOR INFUSION

Contents of the leaflet

1. Introduction
2. What Lipofundina MCT/LCT 20% is and what it is used for
3. What you need to know before you use Lipofundina MCT/LCT 20%
4. How to Use Lipofundina MCT/LCT 20%
5. Possible Side Effects
6. Storage of Lipofundina MCT/LCT 20%
7. Container Contents and Additional Information
8. Method of Administration

Introduction

Package Leaflet: Information for the User

Lipofundina MCT/LCT 20% Emulsion for Infusion

Refined Soybean Oil; Medium-Chain Triglycerides

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack

1. What Lipofundina MCT/LCT 20% is and what it is used for
2. What you need to know before you use Lipofundina MCT/LCT 20%
3. How to use Lipofundina MCT/LCT 20%
4. Possible side effects
5. Storage of Lipofundina MCT/LCT 20%
6. Contents of the pack and other information

1. What Lipofundina MCT/LCT 20% is and what it is used for

Lipofundina MCT/LCT 20% is an oil-in-water emulsion. The oils in Lipofundina MCT/LCT 20% provide energy and contain essential fatty acids, which are necessary for the functions of your body, that your body needs to grow and recover.

You are given Lipofundina MCT/LCT 20% through a drip in a vein (infusion) as part of a treatment for nutrition because you are unable to eat properly or cannot be fed through a nasogastric tube.

2. What you need to know before you use Lipofundina MCT/LCT 20%

Do not use Lipofundina MCT/LCT 20%

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

.

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

• severe increase in blood fat levels (severe hyperlipidemia)
• when you have a disorder in which your blood does not clot properly (severe coagulopathy, bleeding diathesis)
• severe liver failure
• disruption of bile flow (intrahepatic cholestasis)
• blockage of blood vessels by blood clots or fat (acute thromboembolic events, lipid embolism)
• disorders in which your blood is too acidic (metabolic acidosis)
• potentially life-threatening circulation problems, such as those that occur if you are in a state of collapse or shock
• acute phase of heart attack (myocardial infarction) or stroke
• severe kidney failure without dialysis treatment
• untreated disturbances of water and salt balance (electrolyte imbalance), for example, low water and salt content 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

Consult your doctor, pharmacist, or nurse before you start using Lipofundina MCT/LCT.

During infusion, your doctor should regularly monitor the amount of fat in your blood (serum triglycerides). If your blood fat levels become too high, your doctor may reduce the infusion rate or stop it.

Before you receive this medicine, your doctor should correct any existing disturbances of your body's water and salt content, as well as any disturbances of your acid-base balance.

While you are receiving this solution, your doctor should check your fluid, electrolyte, and acid-base balance, as well as your heart function. Your doctor may consider it necessary for you to receive this solution for several weeks. In this case, your liver function and blood coagulation will be closely monitored, and blood counts will be performed.

Allergic reactions to this medicine are extremely rare. If you show signs of an allergic reaction when you receive this medicine - such as fever, chills, hives, or breathing problems, your doctor should immediately stop the infusion.

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

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

When used in children from premature birth to 2 years, the emulsion (including administration equipment) should be protected from light exposure after preparation for infusion until administration is completed. Exposure of parenteral nutrition mixtures containing Lipofundina MCT/LCT 20% to light, especially after mixing with trace elements or vitamins, generates peroxides and other degradation products that can be reduced if the product is protected from light exposure.

Elderly Patients

In some conditions, your ability to use fats correctly may be impaired. Your doctor will take into account that some of these conditions are frequently associated with advanced age, e.g., impaired heart or kidney function.

Patients with Lipid Metabolism Disorders

In some conditions, your ability to use fats correctly may be impaired. Therefore, it is important that your doctor knows:

If your ability to use fats correctly is impaired, your doctor should closely monitor your blood fat levels (serum triglycerides).

Children

In infants at risk of jaundice, your doctor should monitor blood fat levels (serum triglycerides) and bilirubin levels. It may be necessary for your doctor to adjust the daily fat doses.

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

Use of Lipofundina MCT/LCT 20% with Other Medicines:

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

Lipofundina MCT/LCT may interact with some medicines. Tell your doctor if you are taking or receiving certain medicines to control your blood clotting, i.e.:

• heparin
• cumarin derivatives, e.g., warfarin

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

There is not enough data on the use of Lipofundina 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 in women under parenteral nutrition.

Driving and Using Machines

Normally, Lipofundina MCT/LCT is administered to patients in a controlled environment (a hospital or clinic). This will exclude driving and using machines.

Important Information about Some of the Ingredients of Lipofundina MCT/LCT 20%

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

3. How to Use Lipofundina MCT/LCT 20%

This medicine is given by infusion into a vein (intravenous infusion), i.e., through a small tube directly into a vein.

The following doses are guidelines. Your doctor will decide what amount of this medicine you need and for how long you will need treatment with this medicine.

Adults

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

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

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

For a patient with a weight of 70 kg, a daily dose of 1.5 g per kg of body weight and day corresponds to a maximum daily dose of 525 ml of Lipofundina MCT/LCT 20%.

Pediatric Population

A successive increase of lipids in 0.5-1.0 g per kg of body weight and day may be beneficial. It can help your doctor monitor the increase in plasma triglyceride levels and prevent high lipid levels (hyperlipidemia).

Preterm, Neonates, and Infants

A daily dose of more than 3 g (max. 4 g) per kg of body weight and 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 dose of lipids of more than 2-3 g per kg of body weight and day is not recommended.

Infusion Rate

The infusion should be administered at the minimum possible rate. During the first 15 minutes, the infusion rate should be 50% of the maximum infusion rate used. Your doctor should closely monitor you for the appearance of side effects.

Maximum Infusion Rate

Adults

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

For a patient with 70 kg of body weight, this corresponds to a maximum infusion rate of 35 ml per hour of Lipofundina MCT/LCT 20%. The amount of lipids administered is then 7 g per hour.

Preterm, Neonates, and Infants

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

Children and Adolescents

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

4. Possible Side Effects

Like all medicines, Lipofundina MCT/LCT 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, tell your doctor immediately and stop using 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, breathing problems

? breathing problems (dyspnea)

? blue discoloration of the skin (cyanosis)

Other side 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 levels of sugar in the blood (hyperglycemia)

? 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 of cold, chills

? back, bone, chest, and lumbar pain

Not known (cannot be estimated from the available data)

? disruption of bile flow (cholestasis)

? decrease in white blood cell count (leucopenia)

? decrease in platelet count (thrombocytopenia)

Fat Overload Syndrome

You may have "fat overload syndrome" if you have received too much Lipofundina MCT/LCT or when your body has problems with fats. Your body's ability to use fats may be influenced by a sudden change in your condition (due to kidney problems or infection). The symptoms are usually reversible if the infusion is stopped. Fat overload syndrome is characterized by the following symptoms:

? high levels of fat in the blood (hyperlipidemia)

? fever

? fat deposits in the liver or other organs (fatty infiltration)

? 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 (leucopenia)

• decrease in platelet count (thrombocytopenia)

? blood clotting disorder

? breakdown of blood cells (hemolysis)

? increase in immature red blood cells (reticulocytosis)

? abnormal liver function tests

? loss of consciousness

Reporting of Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use.

www.notificaRAM.es

5. Storage of Lipofundina MCT/LCT 20%

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of the month stated.

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 to 2 years, the emulsion (including administration equipment) should be protected from light exposure after preparation for infusion until administration is completed (see section 2).

6. Container Contents and Additional Information

Composition of Lipofundina MCT/LCT 20%:

The active ingredients per 1,000 ml of Lipofundina MCT/LCT 20% are:

Refined soybean oil 100.0 g

Medium-chain triglycerides (MCT) 100.0 g

Essential fatty acid content in 1,000 ml:

Linoleic acid 48.0-58.0 g/l

α-Linolenic acid 5.0-11.0 g/l

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

Product Appearance and Container Contents

Lipofundina MCT/LCT is a white, milky emulsion. It is an emulsion for infusion, i.e., it is administered through a small tube in a vein.

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

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

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

? 500 ml, available in packs 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

Phone: +49-5661-71-3383

Fax: +49-5661-75-3383

Date of Last Revision of this Prospectus: October 2022

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products. http://www.aemps.gob.es

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This information is intended only for healthcare professionals:

Additional Special Warnings and Precautions for Use

Mixing with incompatible substances can lead to separation of the emulsion or precipitation of particles, which carries a high risk of embolism.

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

Exposure to light of parenteral nutrition mixtures for intravenous administration, especially after mixing with trace elements or vitamins, can have adverse effects on the clinical outcome of newborns due to the generation of peroxides and other degradation products. When used in children from premature birth to 2 years, Lipofundina MCT/LCT 20% should be protected from light after preparation for infusion until administration is completed.

Interference with Laboratory Tests

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

Incompatibilities

Lipofundina MCT/LCT should not be used as a carrier solution for electrolyte concentrates or other pharmaceutical products, nor should the emulsion be mixed with other infusion solutions in an uncontrolled manner, as the stability of the emulsion can no longer be guaranteed.

Special Precautions for Disposal and Other Handling

Shake lightly before use.

The emulsion should be brought to room temperature without assistance before infusion, i.e., the product should not be placed in a heating device (such as an oven or microwave).

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

Before infusing a lipid emulsion together with other solutions through a Y-connector or bypass set, the compatibility of these liquids should be checked, especially when administered with vehicle solutions to which drugs have been added. Particular care should be taken when infusing solutions that contain divalent electrolytes (such as calcium or magnesium) simultaneously.

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

When used in children from premature birth to 2 years, parenteral nutrition mixtures containing Lipofundina MCT/LCT 20% should be protected from light exposure after preparation for infusion until administration is completed. Exposure of such mixtures to light, especially after mixing with trace elements or vitamins, generates peroxides and other degradation products that can be reduced by protecting the product from light exposure.

Method of Administration

Lipid emulsions are suitable for peripheral venous administration and can also be administered separately through peripheral veins as part of total parenteral nutrition.

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

Normally, the duration of administration of Lipofundina MCT/LCT 20% is between 1 and 2 weeks. If continued parenteral nutrition with lipid emulsions is indicated, Lipofundina MCT/LCT 20% can be administered for longer periods provided that adequate monitoring is implemented.

When used in children from premature birth to 2 years, the emulsion (including administration equipment) should be protected from light exposure after preparation for infusion until administration is completed.