Prospect: information for the user

Lipofundina MCT/LCT 20% emulsion for perfusion

Refined soybean oil; medium-chain triglycerides

Read this prospect thoroughly before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section 4.

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

2. What you need to know before starting to useLipofundina MCT/LCT 20%

3. How to useLipofundina MCT/LCT 20%

4. Possible adverse effects

5. Storage ofLipofundina MCT/LCT 20%

6. Contents of the package and additional information

LipofundinaMCT/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 your body's functions, that your body needs to grow and recover.

Lipofundina MCT/LCT 20% is administered to you through a vein drip (infusion) as part of a feeding treatment because you are unable to eat adequately or cannot be fed through a nasogastric tube.

No use Lipofundina MCT/LCT 20%

If you are allergicto egg protein or soy protein,to soy products or peanut productsor to any of the componentslisted in section 6.

.

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

-severe increase in blood lipid levels(severe hyperlipidemia)

-when you have a disorder in which the blood does not clot properly (severe coagulopathy, bleeding diathesis)

-severe liver insufficiency

-bile duct obstruction (intrahepatic cholestasis)

-blockage of blood vessels by blood clots or fat (acute thromboembolic events, lipid embolism)

-disorders in which the blood is too acidic (metabolic acidosis)

-potentially life-threatening circulatory disorders, such as those that occur in shock or collapse

-if you have unstable metabolism, for example, due to severe injury or surgical interventions (post-traumatic syndrome), severe infections involving the entire body (severe sepsis) or unknown origin coma

-acute phase of heart attack(myocardial infarction) or stroke

-untreated renal insufficiency without dialysis treatment

-untreated electrolyte imbalance, for example, low water and salt content in the body (hypotonic dehydration) or low potassium levels in the blood (hypokalemia)

-severe heart failure(decompensated heart failure)

-pulmonary edema

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to use Lipofundina MCT/LCT.

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

Before receiving this medication, your doctor must correct any existing alteration of the content of liquids and salts in your body, as well as any alteration of your acid-base balance.

While receiving this solution, your doctor must check your levels of liquids, salts in blood and acid-base balance, as well as your cardiac function. Your doctor may consider it necessary for you to receive this solution for several weeks. In this case, both your liver function and your blood coagulation function will be monitored, and blood tests will be performed.

Allergic reactions to this medication are extremely rare. If you show signs of an allergic reaction when receiving this medication- such as fever, chills, hives or respiratory problems,your doctor must immediately stop the perfusion.

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 too acidic (metabolic acidosis).

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

When used in children between premature birth and 2 years old, the emulsion (including administration equipment) must be protected from light exposure after preparation for perfusion until the end of administration. Exposure ofparenteral nutrition mixtures containingLipofundina MCT/LCT 20%to light, especially after mixing with oligoelements or vitamins, generates peroxides and other degradation products that can be reduced if the product is protected from light exposure.

Geriatric patients

In some cases, your ability to use fats correctly may be altered.Your doctor will take into account that some of these conditions are often associated with advanced age, for example, altered cardiac or renal function.

Patients with lipid metabolism disorders

In some cases, your ability to use fats correctly may be altered.Therefore, it is essential that your doctor knows:

-if you have diabetes mellitus

-if you have pancreatitis

-if you have altered liver or renal function (renal insufficiency, liver insufficiency)

-if you have blood poisoning (sepsis)

-if you have reduced thyroid activity (hypothyroidism)

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

Children

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

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

Use of Lipofundina MCT/LCT 20% with other medications:

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

Lipofundina MCT/LCT may interact with some medications.Inform your doctor if you are takingor receiving certain medications to control blood clotting, namely:

-heparin

-productsderived fromcumarin, eg.warfarin

Pregnancy and lactation

If you are pregnant or breastfeeding, consult your doctor before using this medication.

There are not enough data on the use of Lipofundina MCT/LCT in pregnant women.If you are pregnant, you will only receive this medication if your doctor considers it absolutely necessary for your recovery.

It is not recommended to breastfeed while receiving parenteral nutrition.

Driving and operating machines

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

Important information about some of the components of Lipofundina MCT/LCT 20%

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

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

The following doses are recommended guidelines. Your doctor will decide what amountof this medication you need and for how longyou will needthe treatment with this medication.

Adults

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

In the following groups of patients, the administration of intravenous lipids should not exceed 1g 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 by 0.5-1.0g per kg of body weight and day may be beneficial. It may help your doctor to monitor the increase of plasma triglyceride levels and to prevent excessively high lipid levels (hyperlipidemia).

Preterm, neonates, and infants

It is not recommended to exceed a daily dose of 3g(max. 4g) per kg of body weight and day.

In this age group, the daily dose of lipids should be infused continuously for approximately24 hours.

Children and adolescents

It is not recommended to exceed a daily dose of 2-3g of lipids per kg of body weight and day.

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 adverse effects.

Maximum infusion rate

Adults

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

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

Preterm, neonates, and infants

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

Children and adolescents

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

Like all medications, Lipofundina MCT/LCT may produce adverse effects, although not all people will experience them.

The followingadverse effectsmay be serious. Ifany of the following adverse effectsoccur, inform your doctor immediately and stop administering this medication:

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

?allergic reactions, e.g. skin reactions, difficult breathing,swelling of the lips, mouth, and throat, difficulty breathing

?breathing problems (dyspnea)

?blue discoloration of the skin(cyanosis)

Other adverse effects:

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

?lipid overload syndrome (see "lipid overload syndrome" below)

?tendency of the 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 the 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 available data)

?bile duct obstruction (cholestasis)

?reduction in white blood cell count in the blood (leucopenia)

?reduction in platelet count in the blood (thrombocytopenia)

Lipid overload syndrome

You may have "lipid overload syndrome" if you have received too much Lipofundina MCT/LCT or if 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. Lipid overload syndrome is characterized by the following symptoms:

?high levels of fat in the blood (hyperlipidemia)

?fever

?fat deposition in the liver or other organs (steatosis)

?enlargement of the liver (hepatomegaly), which may be accompanied by jaundice

?enlargement of the spleen (splenomegaly)

?reduction in red blood cell count in the blood (anemia)

?reduction in white blood cell count in the blood (leucopenia)

?reduction in platelet count in the blood (thrombocytopenia)

?blood clotting disorder

?breakdown of red blood cells (hemolysis)

?increase in immature red blood cells (reticulocytosis)

?abnormal liver function tests

?loss of consciousness

Reporting adverse effects

If you experience any type of adverse event, consult your doctor or pharmacist, even if it is an adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use

www.notificaRAM.es

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

Do not use this medication after the expiration datethatappears on the label. The expiration date refers to the last day of the month indicated.

Do not store at a temperature above 25°C. Do not freeze. The product must be discarded if it has been frozen.

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

When used in children between birth and 2 years of age, the emulsion (including the administration equipment) must be protected from exposure to light after preparation for infusion until the infusion is completed (see section2).

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Composition of Lipofundina MCT/LCT 20%:

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

Refined soybean oil100.0 g

Medium-chain triglycerides (MCT)100.0 g

Content of essential fatty acids in 1,000ml:

Linoleic acid48.0‑58.0g/l

??-linolenic acid5.0‑11.0g/l

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

Appearance of the product and content of the package

Lipofundina MCT/LCT is a white, creamy emulsion. It is an infusion emulsion, that is, it is administered through a small tube in a vein.

It is presented in glass vials sealed with rubber stoppers that contain:

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

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

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

B. Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Responsible for manufacturing:

B. Braun Melsungen AG

Carl-Braun Strasse, 1

D-34212 Melsungen

Germany

Phone: +49-5661-71-3383

Fax:+49-5661-75-3383

Last revision date of this leaflet: October 2022

The detailed information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices. http//www.aemps.gob.es

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This information is intended only for healthcare professionals:

Additional warnings and precautions for use

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

In solutions with a higher concentration of lipids (e.g. Lipofundina MCT/LCT 20%), the proportion of emulsifier (phospholipid) to oil is lower than in emulsions with lower lipid concentrations. 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 emulsions.

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

Interference with laboratory tests

Lipids may 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 transport 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 would no longer be guaranteed.

Special precautions for disposal and other manipulations

Gently shake before use.

The emulsion must be brought to room temperature without assistance before infusion,that is, it should not be placed in a heating device (such as an oven or microwave).

If filters are used, they must be permeable to lipids.

Before infusing an emulsion of lipids together with other solutions through a Y-connector or a bypass set, the compatibility of these liquids must be checked, especially when administering solutions containing divalent electrolytes (such as calcium or magnesium). Special care must be taken when infusing simultaneously solutions that contain electrolytes.

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

When used in children between birth and 2 years of age, the parenteral nutrition mixtures containing Lipofundina MCT/LCT 20% must be protected from exposure to light after preparation for infusion until the infusion is completed. Exposure of these mixtures to light, especially after mixing them with oligoelements or vitamins, generates peroxides and other degradation products that can be reduced if the product is protected from light.

Administration form

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

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

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

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