LIPIDEM 200 mg /Ml Emulsion

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Lipidem, 200 mg/ml, Emulsion for Infusion
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is Lipidem and what is it used for
4. Important information before using Lipidem
   1. Lipidem must not be used
   2. Patients generally should not receive artificial nutrition administered through a drip (parenteral nutrition)
   3. Warnings and precautions
   4. Monitoring
   5. Additional precautions
   6. Elderly patients
   7. Patients with heart or kidney dysfunction
   8. Patients with impaired fat metabolism
   9. Children and adolescents
   10. Lipidem and other medicines
   11. Pregnancy and breastfeeding
   12. Driving and using machines
   13. Lipidem contains sodium
5. How to use Lipidem
   1. Dosage
   2. How Lipidem is given
   3. Overdose of Lipidem
6. Possible side effects
   1. The following side effects may be serious. If you experience any of the following side effects, contact your doctor immediately. The doctor will stop the administration of this medicine:
   2. Other side effects include
   3. Fat overload syndrome:
   4. Reporting side effects
7. How to store Lipidem
8. Contents of the pack and other information
   1. What Lipidem contains
   2. What Lipidem looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
   5. Date of last revision of the leaflet: 2023-10-24

Package Leaflet: Information for the Patient

Lipidem, 200 mg/ml, Emulsion for Infusion

Triglycerides of saturated fatty acids with a medium chain length / refined soybean oil / omega-3 fatty acid triglycerides

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Lipidem and what is it used for
• 2. Important information before using Lipidem
• 3. How to use Lipidem
• 4. Possible side effects
• 5. How to store Lipidem
• 6. Contents of the pack and other information

1. What is Lipidem and what is it used for

Lipidem is an oil-in-water emulsion. The oils contained in Lipidem provide a source of energy and essential fatty acids necessary for the growth and recovery of the body. Lipidem is used to provide fats to patients who require intravenous nutrition because they cannot normally eat meals or their normal eating is insufficient. Lipidem can be used in adults, premature infants, full-term newborns, infants, and small children, older children, and adolescents.

2. Important information before using Lipidem

Lipidem must not be used

if the patient has one or more of the following conditions:

• if the patient is allergic to eggs, fish, peanuts, or soybean protein, or to any of the other ingredients of this medicine (listed in section 6);
• severely elevated blood fat levels (severe hyperlipidemia characterized by hypertriglyceridemia);
• diseases in which the blood does not clot properly (severe coagulopathy);
• disorders of bile flow (intrahepatic cholestasis);
• severe liver failure (severe liver dysfunction);
• severe kidney failure (severe renal dysfunction) without access to treatment with an artificial kidney (hemofiltration or dialysis);
• blockage of blood vessels by blood clots or fat (acute thromboembolic event, fat embolism);
• abnormally high levels of acidic substances in the blood (acidosis).

Patients generally should not receive artificial nutrition administered through a drip (parenteral nutrition)

if the patient has one or more of the following conditions:

• life-threatening circulatory disorders, such as those occurring in shock or collapse;
• acute phase of myocardial infarction (heart attack) or stroke;
• unstable metabolism, for example due to diabetes, infection affecting the whole body (severe sepsis), or coma of unknown origin;
• insufficient oxygen supply to tissues;
• electrolyte imbalance in the body;
• fluid deficiency or excess in the body;
• fluid in the lungs (acute pulmonary edema);
• severe heart failure (decompensated heart failure).

Warnings and precautions

Before starting to receive Lipidem, discuss it with your doctor.

Monitoring

• During infusion, the doctor will monitor the fat content (triglycerides) in the patient's blood. If the fat content in the blood becomes too high, the doctor may reduce the infusion rate or stop the infusion.
• During administration of this solution, the doctor will also check the patient's fluid balance, electrolyte levels in the blood, and acid-base balance; liver and kidney function will be monitored, and blood morphology will be determined.
• If the patient experiences any symptoms of an allergic reaction during administration of this medicine, such as fever, chills, rash, or difficulty breathing, the doctor will immediately stop the infusion.

Additional precautions

• Before administering this medicine, the doctor will correct any electrolyte and fluid balance disorders and acid-base balance disorders in the patient.
• In addition to Lipidem, the patient may also receive carbohydrate and amino acid solutions to prevent a metabolic condition in which the blood becomes acidic (acidosis).
• To make parenteral nutrition complete, the patient will also receive carbohydrate and amino acid solutions. Nursing staff will also take appropriate measures to meet the body's needs for fluids, electrolytes, vitamins, and trace elements.

Elderly patients

In some conditions, the body's ability to properly utilize fat may be impaired. The doctor will take into account that some of these conditions are often associated with old age, such as heart or kidney dysfunction.

Patients with heart or kidney dysfunction

If the patient has heart or kidney problems, the doctor will exercise particular caution when administering this medicine.

Patients with impaired fat metabolism

In some conditions, the body's ability to properly utilize fat may be limited, and the fat content in the blood may be too high. Therefore, it is essential to inform the doctor:

• if the patient has diabetes;
• if the patient has pancreatitis;
• if the patient has liver or kidney dysfunction (renal failure, liver failure);
• if the patient has thyroid dysfunction (hypothyroidism);
• if the patient has sepsis;
• if the patient has three or more of the following factors: increased fat in the abdominal area, decreased "good" cholesterol (HDL-C), increased fat in the blood, high blood pressure, and increased sugar in the blood (metabolic syndrome). In case of impaired fat utilization, the doctor will closely monitor the fat content (triglycerides) in the patient's blood.

Children and adolescents

In the case of newborns at risk of jaundice, the doctor should monitor the fat content (triglycerides) and bilirubin in the patient's blood. It may be necessary to adjust the daily fat doses. During infusion, this solution should be protected from the light used for phototherapy to limit the formation of potentially harmful substances (triglyceride hydroperoxides). When used in newborns and children under 2 years of age, the solution (in the bottle and administration set) should be protected from light until the end of administration (see section 2). Exposure of Lipidem to light, especially after the addition of trace elements and/or vitamins, leads to the formation of hydroperoxides and other degradation products, which can be limited by protecting from light.

Lipidem and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. Lipidem may interact with some other medicines. Tell your doctor if you are taking or are given certain medicines that prevent unwanted blood clot formation, i.e.:

• heparin;
• coumarin derivatives, such as warfarin. It may be necessary to check blood clotting by regularly analyzing blood samples.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor for advice before taking this medicine. PregnancyWomen who are pregnant will only be given this medicine if the doctor considers it absolutely necessary for treatment. There is no data on the use of Lipidem in pregnant women. BreastfeedingBreastfeeding is not recommended for mothers receiving parenteral nutrition.

Driving and using machines

This medicine will be administered in a controlled environment, i.e., in a hospital or under medical supervision of another type, which usually excludes driving and operating machines.

Lipidem contains sodium

The medicine contains 59.8 mg of sodium (the main component of common salt) per 1,000 ml. This corresponds to 3% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Lipidem

Dosage

The doctor will decide what dose you need and how long it will be given. Daily doses will be determined based on the patient's needs and age and weight. Doses are usually calculated based on the amount of "grams of fat per kilogram of body weight". Caution will be exercised to ensure that the doses and infusion rates used are suitable for the individual patient, so as not to exceed the body's ability to utilize the infused fat.

How Lipidem is given

Lipidem is given by intravenous infusion as part of a nutrition program. For this purpose, a tube (catheter) is inserted into a vein through which the fat emulsion can be administered alone or with other fluids. When used in newborns and children under 2 years of age, the solution (in the bottle and administration set) should be protected from light until the end of administration (see section 2).

Overdose of Lipidem

If the patient receives too much Lipidem, they may experience too high a level of fat in the blood (hyperlipidemia), the blood may become too acidic (metabolic acidosis), or the patient may experience a condition called fat overload syndrome. The symptoms of fat overload syndrome are listed in section 4 "Possible side effects". If the patient receives too much Lipidem, the infusion will be stopped immediately. The infusion will not be resumed until the patient's condition improves. The doctor may need to adjust the daily fat doses. The doctor will decide on additional treatment. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may be serious. If you experience any of the following side effects, contact your doctor immediately. The doctor will stop the administration of this medicine:

Very rare: may occur in up to 1 in 10,000 people

• allergic reactions, such as skin reactions, shortness of breath, swelling of the lips, mouth, and throat, difficulty breathing;
• breathing disorders (dyspnea);
• bluish discoloration of the skin (cyanosis).

Other side effects include

Very rare: may occur in up to 1 in 10,000 people

• fat overload syndrome (see "Fat overload syndrome" below);
• increased tendency to form blood clots (hypercoagulability);
• abnormally high levels of fat in the blood (hyperlipidemia);
• abnormally high levels of sugar in the blood (hyperglycemia);
• high levels of acidic substances in the blood (metabolic acidosis);
• low or high blood pressure;
• drowsiness;
• nausea, vomiting, loss of appetite;
• headache;
• flushing;
• redness of the skin (flushing);
• fever;
• sweating;
• feeling of cold, chills.

Rare: may occur in up to 1 in 1,000 people

• back pain, bone pain, chest pain, and lower back pain.

Unknown: frequency cannot be estimated from the available data

• disorders of bile flow (cholestasis)
• decreased white blood cell count (leukopenia)
• decreased platelet count (thrombocytopenia)

If any of these side effects occur, the infusion will be stopped.

Fat overload syndrome:

If the patient receives too much Lipidem, the body has difficulty utilizing fat, and a condition called fat overload syndrome may occur. The body's ability to utilize fat may change due to a sudden change in the patient's condition (due to kidney dysfunction or infection). These symptoms are usually reversible after stopping the infusion. Fat overload syndrome is characterized by the following symptoms:

• high levels of fat in the blood (hyperlipidemia);
• fever;
• fat deposits in the liver and other organs (fatty infiltrates);
• enlargement of the liver (hepatomegaly), which may be accompanied by jaundice (icterus);
• enlargement of the spleen (splenomegaly);
• decreased red blood cell count (anemia);
• decreased white blood cell count (leukopenia);
• decreased platelet count (thrombocytopenia);
• blood clotting disorders (coagulation disorders);
• red blood cell breakdown (hemolysis);
• increased number of immature red blood cells (reticulocytosis);
• abnormal liver function test results;
• loss of consciousness (coma).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lipidem

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 carton. The expiry date refers to the last day of the month. After first opening, Lipidem should be used immediately. Do not store above 25°C. Store the container in the outer carton to protect from light. Do not freeze. Products that have been frozen should be discarded. Do not use this medicine if you notice any of the following:

• large oil droplets or two separate layers of liquid;
• discoloration;
• container or closure damage.

When used in newborns and children under 2 years of age, the solution (in the bottle and administration set) should be protected from light until the end of administration (see section 2).

6. Contents of the pack and other information

What Lipidem contains

• The active substances of 1,000 ml of Lipidem are: Triglycerides of saturated fatty acids with a medium chain length 100.0 g Refined soybean oil 80.0 g Omega-3 fatty acid triglycerides 20.0 g

This gives the following content of essential fatty acids per liter: Linoleic acid (omega-6) 38.4-46.4 g Alpha-linolenic acid (omega-3) 4.0-8.8 g Eicosapentaenoic acid and docosahexaenoic acid (omega-3) 8.6-17.2 g 200 mg/ml (20%) corresponds to the total triglyceride content. Energy value [kJ/l (kcal/l)] 7990 (1910) Osmolality [mOsm/kg], approximately 410 Acidity or alkalinity (titration to pH 7.4) [mmol/l NaOH or HCl] <0.5 pH 6.0-8.5

• Other ingredients are glycerol, egg phospholipids for injection, all-rac-α-tocopherol, sodium oleate, sodium hydroxide (for pH adjustment), and water for injection.

What Lipidem looks like and contents of the pack

Lipidem is a milky white, sterile oil-in-water emulsion for intravenous infusion (for administration through a drip into a vein). It is supplied in glass bottles with rubber stoppers; pack sizes: 10 × 100 ml, 1 × 250 ml, 10 × 250 ml, 1 × 500 ml, 10 × 500 ml, 1 × 1,000 ml, 6 × 1,000 ml Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

• B. Braun Melsungen AG Carl-Braun-Straße 1 34212 Melsungen, Germany

Address for correspondence34209 Melsungen, Germany

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria: Lipidem Czech Republic: Lipoplus 20% Germany: Lipidem Denmark: Lipidem Spain: Lipoplus 20% Finland: Lipoplus 200 mg/ml France: Lipidem 200 mg/ml United Kingdom (Northern Ireland): Lipidem 200 mg/ml Emulsion for Infusion Italy: Lipidem 200 mg/ml Luxembourg: Lipidem Norway: Lipidem Portugal: Lipoplus Sweden: Lipoplus Slovakia: Lipoplus 20% Poland Lipidem

Date of last revision of the leaflet: 2023-10-24

--------------------------------------------------------------------------------------------------------------------------- Information intended for healthcare professionals only: Method of administration and special precautions for disposal and handling of the medicinal productIntravenous administration. Fat emulsions are suitable for administration into peripheral veins and can be administered into peripheral veins alone as part of total parenteral nutrition. When administering fat emulsions simultaneously with amino acid and carbohydrate solutions, a Y-connector or bypass connector should be placed as close to the patient as possible. When used in newborns and children under 2 years of age, the solution (in the bottle and administration set) should be protected from light until the end of administration. For single use only. The packaging and any unused portions of the product should be disposed of. Do not connect partially used containers. Gently shake before use. Only use undamaged containers containing a homogeneous, milky white emulsion. Before administration, the emulsion should be inspected for phase separation and discoloration (presence of oil droplets, oil layer). Before infusion, the emulsion should be brought to room temperature without assistance, i.e., the product should not be placed in any heating device (such as a heater or microwave). If filters are used, they must be fat-permeable. Before administering the fat emulsion with other solutions through a Y-connector or bypass set, the compatibility of these fluids should be checked, especially when administering with carrier solutions containing other medicines. Particular caution should be exercised when administering solutions containing divalent cations (e.g., calcium or magnesium). Special precautions for disposal and preparation of the medicinal product for administrationWhen used in newborns and children under 2 years of age, the solution (in the bottle and administration set) should be protected from light until the end of administration. Exposure to light of parenteral nutrition solutions, especially after the addition of trace elements and/or vitamins, may lead to the formation of hydroperoxides and other degradation products, which can be limited by protecting from light. Duration of treatmentSince clinical experience with long-term use of Lipidem is limited, it should not normally be administered for more than one week. If prolonged parenteral nutrition with fat emulsions is indicated, Lipidem can be administered for a longer period under appropriate monitoring. Infusion rateThe 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 used. Maximum infusion rate in adultsUp to 0.15 g lipids/kg body weight/hour. Maximum infusion rate in premature infants, full-term newborns, infants, and small childrenUp to 0.15 g lipids/kg body weight/hour. Maximum infusion rate in older children and adolescentsUp to 0.15 g lipids/kg body weight/hour. Effect on laboratory testsFats can interfere with the results of certain laboratory tests (such as bilirubin, lactate dehydrogenase, oxygen saturation) if a blood sample is taken before the elimination of fats from the circulating blood, which may take 4 to 6 hours. IncompatibilitiesDo not mix the medicinal product with other medicinal products, as compatibility studies have not been performed. Shelf life after addition of compatible substancesFrom a microbiological point of view, the product should be used immediately after addition of other substances. If the product is not used immediately after addition of other substances, the responsibility for the storage time and conditions lies with the user. Full information on this product is given in the Summary of Product Characteristics for Lipidem. Additional special precautions and warnings for useExposure to light of parenteral nutrition solutions, especially after the addition of trace elements and/or vitamins, may have undesirable effects on the clinical response in newborns due to the formation of hydroperoxides and other degradation products. When used in newborns and children under 2 years of age, Lipidem should be protected from light until the end of administration.