LipoPlus 20%
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Lipoplus 20%
Medium-chain triglycerides / refined soybean oil / omega-3 fatty acid triglycerides
Read all of this leaflet carefully before you start taking this medicine because 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 or pharmacist.
- 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 or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of this leaflet
- What Lipoplus 20% is and what it is used for
- What you need to know before you start taking Lipoplus 20%
- How to take Lipoplus 20%
- Possible side effects
- How to store Lipoplus 20%
- Contents of the pack and other information
1. What Lipoplus 20% is and what it is used for
Lipoplus 20% is an oil-in-water emulsion. The oils contained in Lipoplus 20% provide energy and contain essential fatty acids necessary for growth and recovery.
Lipoplus 20% is used to supply fats to patients who require intravenous infusion feeding because they are unable to eat normally or their oral intake is insufficient.
Lipoplus is indicated in adults, premature newborn infants, full-term newborn infants, infants and young children, children, and adolescents.
2. What you need to know before starting to take Lipoplus 20%
Do NOT use Lipoplus 20%
if any of the following conditions apply:
- If you are allergic to egg, fish, peanut, or soybean proteins, or to any of the other components of this medicine (listed in section 6).
- Abnormally high levels of fats in the blood (severe hyperlipidemia characterized by hypertriglyceridemia).
- Conditions in which blood does not clot properly (severe coagulopathy).
- Disorder in bile secretion (intrahepatic cholestasis).
- Severe liver failure.
- Severe renal failure without access to treatment with an artificial kidney (hemofiltration or dialysis).
- Blockage of blood vessels due to blood or fat clots (acute thromboembolic events, fat embolism).
- Abnormally high levels of acidic substances in the blood (acidosis).
Patients should generally not receive artificial nutrition via intravenous infusion (parenteral nutrition) if any of the following conditions apply:
- Potentially life-threatening circulatory problems such as those occurring during collapse or shock.
- Acute phase of heart attack (myocardial infarction) or stroke.
- Unstable metabolism, e.g., due to diabetes mellitus, severe systemic infections (severe sepsis), or coma of unknown origin.
- Inadequate oxygen supply to tissues.
- Disorders in the balance of salts in your body.
- Dehydration or excess water in the body.
- Fluid in the lungs (acute pulmonary edema).
- Severe heart failure (decompensated cardiac failure).
Warnings and precautions
Talk to your doctor before starting to use Lipoplus 20%.
Monitoring
-
During infusion, your doctor must monitor the level of fats (serum triglycerides) in your blood. If fat levels in your blood rise too high, your doctor may reduce the infusion rate or stop the infusion.
-
While you are receiving this solution, your doctor must check your fluid status, blood electrolyte concentrations, and acid-base balance. Liver and kidney function, as well as blood coagulation, should be monitored. Blood cell counts should also be performed.
-
If you show signs of an allergic reaction (such as fever, chills, skin rash, or breathing difficulties) while receiving this medicine, your doctor must stop the infusion immediately.
Additional measures
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Before receiving this medicine, your doctor will correct any existing disturbances in your body's fluid and electrolyte balance, as well as any acid-base imbalances.
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In addition to Lipoplus 20%, you may receive a carbohydrate solution and an amino acid solution to prevent metabolic disorders that cause your blood to become 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 your body's requirements for fluids, electrolytes, vitamins, and trace elements are met.
Elderly patients
In certain disorders, your ability to properly metabolize fats may be impaired. Your doctor will take into account that some of these disorders are frequently associated with advanced age, e.g., impaired heart or kidney function.
Patients with heart or kidney problems
If you have heart or kidney problems, your doctor will be especially cautious when administering this medicine.
Patients with impaired lipid metabolism
In certain disorders, your ability to properly metabolize fats may be impaired, and fat levels in your blood may become too high. Therefore, it is important that your doctor knows:
- if you have diabetes mellitus
- if you have inflammation of the pancreas (pancreatitis)
- if you have liver failure or impaired kidney function
- if you have reduced activity of the thyroid gland (hypothyroidism)
- if you have blood poisoning (sepsis)
- if you have a disorder in which you may have a combination of three or more of the following: increased abdominal fat, low “good cholesterol” (HDL-C), elevated blood fats, high blood pressure, and elevated blood sugar (metabolic syndrome)
If your ability to properly metabolize fats is impaired, your doctor must carefully monitor your blood fat levels (serum triglycerides).
Children and adolescents
In infants at risk of jaundice, your doctor must monitor blood levels of fat (serum triglycerides) and bilirubin. Your doctor may need to adjust the daily dose of fat.
During infusion, this solution must be protected from phototherapy light to reduce the formation of potentially harmful substances (triglyceride hydroperoxides).
When used in newborns and children under 2 years of age, the solution (in bottles and administration sets) must be protected from light exposure until administration is complete. Exposure of Lipoplus 20% to ambient 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.
Taking Lipoplus 20% with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Lipoplus 20% may interact with other medicines. Inform your doctor if you are taking or receiving certain medicines that may undesirably prevent blood from clotting, i.e.:
? heparin
? coumarin derivatives, e.g., warfarin.
It may be necessary to monitor your blood clotting by taking regular blood samples.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.
Pregnancy
You will only receive this medicine during pregnancy if your doctor considers it absolutely necessary for your recovery. There are no data on the use of Lipoplus 20% in pregnant women.
Breastfeeding
Breastfeeding is not recommended for mothers receiving parenteral nutrition.
Driving and using machines
You will receive this medicine in a controlled setting, e.g., in a hospital or under other medical supervision, which normally excludes driving and operating machinery.
Lipoplus 20% contains sodium
This medicine contains 59.8 mg of sodium (main component of table/cooking salt) per 1000 ml. This corresponds to 3% of the maximum daily recommended sodium intake for an adult.
3. How to use Lipoplus 20%
Dosage
Your doctor will decide the dose of this medicine and the duration of treatment. Daily doses will be adjusted according to your individual needs, age, and body weight. Doses are usually calculated based on “grams of fat per kg of body weight.” Special attention will be paid to ensuring that the doses and infusion rates used are appropriate for you, in order to avoid exceeding your capacity to metabolize the infused fat.
How is Lipoplus 20% administered?
Lipoplus 20% is administered by intravenous infusion as part of a nutritional regimen. For this purpose, a tube (catheter) will be inserted into a vein, through which the fat emulsion can be given either separately or together with other fluids.
When used in newborns and children under 2 years of age, the solution (in bottles and administration sets) must be protected from exposure to light until administration is complete (see section 2).
If you receive more Lipoplus 20% than you should
If you have received too much Lipoplus 20%, you may experience abnormally high levels of fat in the blood (hyperlipidemia), your blood may become too acidic (metabolic acidosis), or you may develop the so-called “fat overload syndrome.” For a list of symptoms of fat overload syndrome, see section 4, “Possible side effects.”
If you have received too much Lipoplus 20%, the infusion will be stopped immediately and will not be resumed until you have recovered. Your doctor may need to adjust your daily fat doses. Your doctor will decide on any additional treatment required.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following side effects may be serious. If you experience any of the following side effects, contact your doctor immediately and treatment with this medicine will be stopped:
Very rare: may affect up to 1 in 10,000 people
- allergic reactions, for example, skin reactions, difficulty breathing, swelling of the lips, mouth and throat, breathing difficulties
- breathing problems (dyspnea)
- bluish skin (cyanosis)
Other adverse effects include
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 fats (hyperlipidemia)
- abnormally high levels of sugar (hyperglycemia)
- elevated levels of acidic substances in your blood (metabolic acidosis)
- decrease or increase in blood pressure
- drowsiness
- feeling dizzy, vomiting, loss of appetite
- headache
- flushing
- redness of the skin (erythema)
- fever
- sweating
- feeling cold, chills
Rare: may affect up to 1 in 1,000 people
- pain in the back, bones, chest and lower back area
Frequency not known: cannot be estimated from available data
- disturbance in bile flow (cholestasis)
- reduced white blood cell count (leukopenia)
- reduced platelet count (thrombocytopenia)
If you experience any of these side effects, the infusion will be interrupted.
Fat overload syndrome
You may develop a "fat overload syndrome" if you have received too much Lipoplus 20% or when your body has difficulty utilizing fats. Your body's ability to metabolize fats may be affected by a sudden change in your condition (due to kidney problems or infection). Usually, symptoms are 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 deposition in the liver or other organs (fat infiltration)
- enlarged liver (hepatomegaly), which may sometimes be accompanied by jaundice
- enlarged spleen (splenomegaly)
- reduced red blood cell count (anemia)
- reduced white blood cell count (leukopenia)
- reduced platelet count (thrombocytopenia)
- blood clotting abnormalities
- destruction of red blood cells (hemolysis)
- increased immature red blood cells (reticulocytosis)
- abnormal liver function test results
- loss of consciousness (coma)
Reporting of adverse effects
If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Lipoplus 20%
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and packaging. The expiry date refers to the last day of the month indicated.
Lipoplus 20% must be used immediately after first opening.
Do not store above 25 °C.
Keep the container in the original packaging to protect it from light.
Do not freeze. Products that have been frozen must be discarded.
Do not use this medicine if you observe:
- large oil droplets in the emulsion or two separated layers of liquid
- change in colour
- damage to the container or closure
When used in newborns and children under 2 years of age, the solution (in bottles and administration sets) must be protected from exposure to light until administration is complete (see section 2).
6. Contents of the container and other information
Composition of Lipoplus 20%
- Active substances in 1000 ml of Lipoplus 20%:
Medium-chain triglycerides | 100.0 g | |||||||||||||||||||||||||||||||||||||||||||||||
Soybean oil, refined | 80.0 g | |||||||||||||||||||||||||||||||||||||||||||||||
Omega-3 fatty acid triglycerides | 20.0 g | |||||||||||||||||||||||||||||||||||||||||||||||
This provides the following content of essential fatty acids per liter:
200 mg/ml (20%) corresponds to the total triglyceride content.
Appearance of the product and contents of the pack Lipoplus 20% is a sterile, white, milky oil-in-water emulsion for infusion (for intravenous drip administration). It is marketed in glass bottles with rubber stoppers, in the following pack sizes: 10 × 100 ml, 10 × 250 ml, 10 × 500 ml Not all pack sizes may be marketed. Marketing Authorization Holder and Manufacturer [To be completed at national level]
34212 Melsungen, Germany Mailing address 34209 Melsungen, Germany This medicinal product is authorized in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:
Date of last review of this leaflet: 04/2026 ------------------------------------------------------------------------------------------------------------------- This information is intended for healthcare professionals only: Method of administration and special precautions for disposal and other handling Intravenous route. Lipid emulsions are suitable for peripheral venous administration and may also be given separately through peripheral veins as part of total parenteral nutrition. The Y-connector or bypass set should be placed as close as possible to the patient when lipid emulsions are administered simultaneously with amino acid and carbohydrate solutions. Method of administration When used in newborns and children under 2 years of age, the solution (in bottles and administration sets) must be protected from light exposure until administration is complete. For single use only. The container and any unused medication must be discarded after use. Do not combine partially used containers. Gently shake before use. Use only undamaged containers in which the emulsion appears homogeneous and milky white. Visually inspect the emulsion for phase separation or color changes prior to administration (oil droplets, oil layer). The emulsion should be brought to room temperature naturally before infusion; that is, 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 fat emulsion together with other solutions via a Y-connector or bypass set, compatibility of these fluids should be verified, especially when transport solutions to which other medications have been added are administered simultaneously. Particular attention should be paid when infusing solutions containing divalent cations (e.g., calcium or magnesium) simultaneously. Special precautions for disposal and other handling: When used in newborns and children under 2 years of age, protection from light exposure must be maintained until administration is complete. Exposure of Lipoplus 20% to ambient light, particularly 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. Duration of treatment Since clinical experience with long-term use of Lipoplus is limited, this medicine should not be administered for longer than one week. If parenteral nutrition with lipid emulsions remains indicated, Lipoplus may be administered for longer periods provided adequate monitoring is implemented. Infusion rate The infusion should be administered at the lowest possible rate. During the first 15 minutes, the infusion rate should be only 50% of the maximum infusion rate. Maximum infusion rate for adults Up to 0.15 g/kg body weight/h of lipids. Maximum infusion rate for premature neonates, term neonates, infants, and young children Up to 0.15 g/kg body weight/h of lipids. Maximum infusion rate for children and adolescents Up to 0.15 g/kg body weight/h of lipids. 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, which may take between 4 and 6 hours. Incompatibilities In the absence of compatibility studies, this medicine must not be mixed with others. Stability period after mixing with compatible additives From a microbiological standpoint, the product should be used immediately after mixing with additives. If not used immediately, storage times and conditions prior to use are the responsibility of the user. To view the complete information on this product, refer to the Summary of Product Characteristics or Package Leaflet of Lipoplus 20%. Warnings and special precautions for use Exposure to light of intravenous parenteral nutrition solutions, especially after mixing with trace elements or vitamins, may have adverse effects on clinical outcomes in newborns due to the formation of peroxides and other degradation products. When used in newborns and children under 2 years of age, Lipoplus 20% must be protected from ambient light until administration is complete. |