Prospect: information for the user

Lipofundina MCT/LCT 10% emulsion for perfusion

Refined soybean oil; medium-chain triglycerides

Read this prospect carefully 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 are not listed in this prospect. See section 4.

1. What is Lipofundina MCT/LCT 10% and how it is used

2. What you need to know before starting to use Lipofundina MCT/LCT 10%

3. How to use Lipofundina MCT/LCT 10%

4. Possible adverse effects

5. Storage of Lipofundina MCT/LCT 10%

6. Contents of the package and additional information

Lipofundina MCT/LCT 10% is a water-in-oil emulsion. The oils in Lipofundina MCT/LCT 10% 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 10% 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.

Do not use Lipofundina MCT/LCT 10%

• If you are allergic to egg protein or soy protein, soy products or peanut products, or any of the components of this medication (including those listed 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

-Biliary tract 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 if you are 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 (acute 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 rise too high, your doctor may reduce the perfusion rate or stop it.

Before receiving this medication, your doctor must correct any existing imbalance of fluids and electrolytes in your body, as well as any imbalance of your acid-base balance.

While receiving this solution, your doctor must check your fluid, electrolyte levels 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 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 fluids, electrolytes, vitamins and trace elements are met.

When used in children aged between premature birth and 2 years, the emulsion (including administration equipment) must be protected from exposure to light after preparation for perfusion until the end of administration. Exposure of parenteral nutrition mixtures containing Lipofundina MCT/LCT 10% 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 exposure to light.

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 gland 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 from phototherapy to reduce the formation of potentially damaging substances (triglyceride hydroperoxides).

Use of Lipofundina MCT/LCT 10% 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 coagulation, namely:

-Heparin

-Coumarin derivatives, e.g. Warfarin

Pregnancy, lactation and fertility

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

There is insufficient data on the use of Lipofundina MCT/LCT in pregnant women.Si you arepregnant, you will only receive this medication if your doctor considers it absolutely necessary for your recovery.

It is not recommended to breastfeed women under 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 10%

This medication contains less than 1 mmol of sodium (23 mg) 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 orientative recommendations.Your doctor will decide how muchof this medication you need and for how longyou will needtreatment 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 70kg, a daily dose of 1.5g per kg of body weight and day corresponds to a maximum daily dose of 1,050ml of Lipofundina MCT/LCT 10%.

Pediatric population

A successive increase of lipids by 0.5-1g 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 high lipid levels (hyperlipidemia).

Preterm, neonates and infants

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

In this age group, the daily dose of lipids should be infused continuouslyapproximately for24 hours.

Children and adolescents

It is not recommended to exceed a daily dose of lipids of 2-3g 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 0.10 g 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 70ml per hour of Lipofundina MCT/LCT 10%. 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.

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

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

Ifyou have receivedtoo muchLipofundina MCT/LCT,your lipid levels may be abnormally increased (hyperlipidemia),your blood may become too acidic (metabolic acidosis) or you may experienceacalled«lipid overload syndrome».For symptoms of lipid overload syndrome seesection 4.

If these adverse effects appear during treatment, stop the infusion of Lipofundina MCT/LCT. The infusion will not start again until you have recovered. You may need your doctor to adjust your daily lipid doses. Your doctor will decide on any additional treatment.

Like all medications, Lipofundina MCT/LCTMCT/LCTmay cause side effects, although not everyone will experience them.

The followingside effectsmay be serious. Ifany of the following side effects occur, inform your doctor immediately and discontinue administration of this medication:

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 breathing

?breathing problems (dyspnea)

?blue discoloration of the skin (cyanosis)

Other side effects:

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

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

?increased tendency of 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

?sensation of cold, chills

?back, bone, chest, and lumbar region pain

Unknown(cannot be estimated from available data)

?bile flow alteration (cholestasis)

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

?reduction in platelet count in blood (thrombocytopenia)

Lipid Overload Syndrome

Youmay have "lipid overload syndrome" if you have received too much Lipofundina MCT/LCT or if your body has problems with fats. The ability of your body 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 blood (anemia)

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

?reductionin platelet count in blood (thrombocytopenia)

?blood coagulation disorder

?fragmentation of 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Usewww.notificaRAM.es

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

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

Do not store at a temperature above25?°C. Do not freeze. The product must be discarded if it has been frozen.

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

When used in children from birth to 2years, the emulsion (including administration equipment) must be protected from exposure to light after preparation for infusion until the end of administration (see sectionConverted with the trial version of Word Cleaner Server Version, it will only convert 75% of a document.
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Composition of Lipofundina MCT/LCT 10%

The active principles for each 1.000ml of Lipofundina MCT/LCT 10% are:

Refined soybean oil50.0g

Medium-chain triglycerides (MCT)50.0g

Content of essential fatty acids in 1.000ml:

Linoleic acid24.0‑29.0g/l

??-linolenic acid2.5‑5.5g/l

The other components areglycerol, egg phospholipids for preparation of injectable solutions,all-rac-α-tocopherol, sodium oleate (for pH adjustment) and water for injectable solutions.

Aspect of the product and contents of the container

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

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

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

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

?500ml, available in packs 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 review date of this leaflet: October 2022

This information is intended solely for healthcare professionals:

Additional warnings and precautions for use

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

Insolutionswith a higher lipid concentration (e.g. Lipofundina MCT/LCT 20%), the emulsifier (phospholipid) ratio 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 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 the parenteral nutrition mixtures for intravenous administration, especially after mixing 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 from birth to 2years, Lipofundina MCT/LCT 10%must be protected from light exposure after preparation for infusion until the end of administration.

Interference with laboratory tests

Fats may interfere with certain laboratory tests (such as bilirubin, lactate dehydrogenase, oxygen saturation) when the blood sample is taken before the fats 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 emulsion's stability would no longer be guaranteed.

Special precautions for disposal and other manipulations

Gently shake before use.

The emulsion should be brought to room temperature without assistance before infusion, that is, the product 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 a lipid emulsion with other solutions through a Y-connector or bypass set, the compatibility of these liquids must be checked, especially when administering solutions containing divalent ions (such as calcium or magnesium). Special care must be taken when infusing solutions simultaneously 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 from birth to 2years, the parenteral nutrition mixtures containingLipofundina MCT/LCT 10%must be protected from light exposure after preparation for infusion until the end of administration. Exposure of these mixtures 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.

Administration form

Lipid emulsions are suitable for peripheral venous administration and can also be administered 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 bypass set should be placed as close as possible to the patient.

Normally, the duration of administration of Lipofundina MCT/LCT 10% is between 1 and 2 weeks. If it is indicated to continue parenteral nutrition with lipid emulsions, Lipofundina MCT/LCT 10% can be administered for longer periods as long as adequate monitoring is implemented.

Normally, the duration of administration of Lipofundina MCT/LCT 10% is between 1 and 2 weeks. If it is indicated to continue parenteral nutrition with lipid emulsions, Lipofundina MCT/LCT 10% can be administered for longer periods as long as adequate monitoring is implemented.

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