Lipoplus 20%

Инструкция по применению Lipoplus 20%

Introduction

Package Insert: Information for the Patient

Lipoplus 20%

Medium-Chain Triglycerides / Refined Soybean Oil / Omega-3 Triglycerides

Read this package insert carefully before starting to take this medication, as it contains important information for you.

Keep this package insert, as you may need to refer to it again.
If you have any questions, consult your doctor or pharmacist.
This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Lipoplus 20% and what it is used for

2. What you need to know before starting to take Lipoplus 20%

3. How to take Lipoplus 20%

4. Possible adverse effects

5. Storage of Lipoplus 20%

6. Contents of the package and additional information

1. What is Lipoplus 20% and what is it 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 your body to grow or recover.

Lipoplus 20% is used to provide fats to patients who need to be fed intravenously by drip, as they are unable to ingest food normally or their intake is insufficient.

Lipoplus is indicated for adults,preterm newborns, term newborns, infants, small 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 are present:

If you are allergic to egg, fish, peanut, or soy proteins or to any of the other components of this medication (listed in section 6).
Severe high levels of fats in the blood (severe hyperlipidemia characterized by hypertriglyceridemia).
Bleeding disorders (severe coagulopathy).
Bile duct obstruction (intrahepatic cholestasis).
Severe liver failure.
Severe kidney failure without access to renal replacement therapy (hemofiltration or dialysis).
Blockage of blood vessels by blood clots or fat (acute thromboembolic events, fat embolism).
Severe acidosis (abnormally high levels of acidic substances in the blood).

Patients should generally not receive parenteral nutrition (intravenous nutrition) if they have any of the following conditions:

Life-threatening circulatory problems that may occur in shock or collapse.
Acute phase of heart attack (myocardial infarction) or stroke.
Unstable metabolism, e.g., due to diabetes mellitus, severe infections (sepsis), or unknown origin coma.
Inadequate oxygen supply to tissues.
Electrolyte imbalances.
Dehydration or excessive water in the body.
Pulmonary edema (fluid in the lungs).
Severe heart failure (decompensated heart failure).

Warnings and precautions

Consult your doctor before starting to use Lipoplus 20%.

Monitoring

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

While receiving this solution, your doctor should check your fluid levels, blood electrolyte concentrations, and acid-base balance. Liver and kidney function, as well as blood clotting, 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 respiratory problems) when receiving this medication, your doctor should immediately stop the infusion.

Additional measures

Before receiving this medication, your doctor will correct any existing fluid and electrolyte imbalances, as well as acid-base disturbances.

In addition to Lipoplus 20%, you may receive a carbohydrate solution and an amino acid solution to prevent metabolic disturbances where your blood becomes acidic (metabolic acidosis).

To make your intravenous nutrition complete, you may also receive carbohydrate and amino acid solutions. Nursing staff will also take measures to ensure that your fluid, electrolyte, vitamin, and mineral requirements are met.

Geriatric patients

In some conditions, 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, e.g., heart or kidney function impairment.

Patients with heart or kidney problems

If you have heart or kidney problems, your doctor will be particularly attentive when administering this medication.

Patients with lipid metabolism disorders

In some conditions, your ability to use fats correctly may be altered, and your blood fat levels may be too high. Therefore, it is essential that your doctor knows:

if you have diabetes mellitus
if you have pancreatitis (inflammation of the pancreas)
if you have liver failure or impaired kidney function
if you have hypothyroidism (reduced thyroid function)
if you have sepsis (blood poisoning)
if you have a condition where you may have a combination of 3 or more of the following: increased abdominal fat, decreased "good" cholesterol (HDL-C), increased blood fats, high blood pressure, and increased blood sugar (metabolic syndrome)

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

Children and adolescents

In newborns at risk of jaundice, your doctor should monitor blood fat levels (serum triglycerides) and bilirubin levels. Your doctor may need to adjust your daily fat doses.

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

When used in newborns and children under 2 years, the solution (in bottles and administration equipment) should be protected from exposure to light until the administration is complete. Exposure of Lipoplus 20% to ambient light, especially after mixing it with oligoelements or vitamins, generates peroxides and other degradation products that can be reduced by protecting the product from light exposure.

Lipoplus 20% with other medications

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

Lipoplus 20% may interact with other medications. Inform your doctor if you are taking or receiving certain medications that may prevent blood clotting in an undesirable manner, such as:

? heparin

? Coumarin products, e.g., warfarin.

You may need to have your blood clotting checked by taking regular blood samples.

Pregnancy and lactation

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

Pregnancy

You will only receive this medication if your doctor considers it absolutely necessary for your recovery. There are no data on the use of Lipoplus 20% in pregnant women.

Lactation

It is not recommended to breastfeed mothers receiving parenteral nutrition.

Driving and operating machinery

You will receive this medication in a controlled environment, e.g., a hospital or under medical supervision, which usually excludes driving and operating machinery.

Lipoplus 20% contains sodium

This medication contains 59.8 mg of sodium (main component of table salt/for cooking) in each 1000 ml. This is equivalent to 3% of the recommended daily maximum sodium intake for an adult.

3. How to use Lipoplus 20%

Dosage

Your doctor will decide the dosage of this medication and the duration of treatment to follow. Daily doses will be adjusted according to your needs, age, and body weight. Doses are normally calculated based on "grams of fat per kg of body weight". Special attention will be paid to ensure that the doses and infusion rates used are correct for you, to avoid exceeding your capacity for using the infused fat.

How is Lipoplus 20% administered?

Lipoplus 20% is administered through an intravenous drip as part of a nutrition program. For this purpose, a tube (catheter) will be inserted into a vein, through which the fat emulsion can be administered separately or together with other liquids.

When used in newborns and children under 2 years, the solution (in the bottles and administration equipment) must be protected from exposure to light until the end of administration (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 your blood (hyperlipidemia), your blood may become too acidic (metabolic acidosis), or you may suffer from the so-called "fat overload syndrome". To see the 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. You may need your doctor to adjust your daily doses of fat.Your doctor will decide on any additional treatment.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The following side effects may be serious. If any of the following side effects occur, contact your doctor immediately and this medicine will be discontinued:

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, difficult breathing
breathing problems (dyspnea)
blue skin (cyanosis)

Other side effects include

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

lipid overload syndrome (see "Lipid Overload Syndrome" below)
increased tendency of blood to clot (hypercoagulation)
abnormally high levels of fats in the blood (hyperlipidemia)
abnormally high levels of sugar in the blood (hyperglycemia)
high levels of acidic substances in the blood (metabolic acidosis)
decrease or increase in blood pressure
drowsiness
sensation of dizziness, vomiting, loss of appetite
headache
flushing
skin redness (erythema)
fever
sweating
sensation of cold, chills

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

back, bone, chest, and lower back pain

Frequency not known: cannot be estimated from available data

bile flow alteration (cholestasis)
reduction in white blood cell count (leucopenia)
reduction in platelet count (thrombocytopenia)

If you experience any of these side effects, the infusion will be interrupted.

Lipid Overload Syndrome

You may experience a "lipid overload syndrome" if you have received too much Lipoplus 20% or if your body has trouble using fats. Your body's ability to use fats may be influenced by a sudden change in your condition (due to kidney problems or an infection). Usually, symptoms are reversible if the infusion is interrupted. Lipid 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 (steatosis)
enlarged liver (hepatomegaly), which may be accompanied by jaundice
enlarged spleen (splenomegaly)
reduction in red blood cell count (anemia)
reduction in white blood cell count (leucopenia)
reduction in platelet count (thrombocytopenia)
blood clotting disorder
red blood cell destruction (hemolysis)
increase in immature red blood cells (reticulocytosis)
abnormal liver function test results
loss of consciousness (coma)

Reporting Adverse Reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Lipoplus 20%

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

Do not use this medication after the expiration date that appears on the label and on the packaging. The expiration date is the last day of the month indicated.

Lipoplus 20% must be used immediately after the first opening.

Do not store at a temperature above 25 °C.

Store the packaging in the original container to protect it from light.

Do not freeze. Products that have been frozen must be discarded.

Do not use this medication if you observe:

large oil droplets in the emulsion or two separate liquid layers
color change
damage to the packaging or closure

When used in newborns and children under 2 years, the solution (in bottles and administration equipment) must be protected from exposure to light until the administration is completed (see section 2).

6. Contents of the packaging and additional information

Composition of Lipoplus 20%

- Active principles in 1000 ml of Lipoplus 20%:

Medium-chain triglycerides

100.0 g

Refined soybean oil

80.0 g

Triglycerides with omega-3 fatty acids

20.0 g

This provides 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 content of triglycerides.

Energy [kJ/l (kcal/l)]	7990 (1910)
Osmolality [mOsm/kg], approximately	410
pH (adjustment to pH 7.4) [mmol/l NaOH or HCl]	<0.5
pH	6.0 - 8.5

- The other components are glycerol, egg phospholipids for injectable preparations, all-rac-alpha-tocopherol, sodium oleate, sodium hydroxide for pH adjustment, and water for injectable preparations.

Aspect of the product and contents of the container

Lipoplus 20% is a white and sterile oil-in-water emulsion for infusion (for administration by intravenous drip).

It is marketed in glass bottles with rubber stoppers, formats:

10 × 100 ml, 1 × 250 ml, 10 × 250 ml, 1 × 500 ml, 10 × 500 ml, 1 × 1000 ml, 6 × 1000 ml

It may not be marketed in all formats.

Holder of the marketing authorization and responsible for manufacturing

[To be completed at national level]

B. Braun Melsungen AG Carl-Braun-Straße 1

34212 Melsungen, Germany

Postal address

34209 Melsungen, Germany

This medicinal product is authorized in the member states of the European Economic Community and in the United Kingdom (Northern Ireland) with the following names:

Austria	Lipidem Emulsion zur Infusion

Czech Republic	Lipoplus 20%
Germany	Lipidem Emulsion zur Infusion
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
Poland	Lipidem
Portugal	Lipoplus
Sweden	Lipoplus
Slovakia	Lipoplus 20%

Last review date of this leaflet:09/2023

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This information is intended solely for healthcare professionals:

Administration form and special precautions for disposal and other manipulations

Intravenous.

Oil emulsions are suitable for peripheral venous administration and can also be administered 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 if oil emulsions are administered simultaneously with amino acid and carbohydrate solutions.

Administration form

When used in newborns and children under 2 years, the solution (in the bottles and administration equipment) should be protected from exposure to light until the end of administration.

For single use only. The container and unused medication should be disposed of after use. Do not combine partially used containers. Gently shake before use.

Use only containers that are not damaged and in which the emulsion is homogeneous and white.

Visually inspect the emulsion to check for the absence of phase separation and color changes (oil droplets, oil layer) before administration.

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 should be permeable to lipids.

Before infusing a fat emulsion together with other solutions through a Y-connector or bypass set, the compatibility of these liquids should be checked, especially when administering solutions that have been added to other medications. Special attention should be paid when infusing solutions that contain divalent cations (such as calcium or magnesium) simultaneously.

Special precautions for disposal and other manipulations:

When used in newborns and children under 2 years, it should be protected from exposure to light until the end of administration. Exposure of Lipoplus 20% to ambient light, especially after mixing it with oligoelements or vitamins, generates peroxides and other degradation products that can be reduced if the product is protected from exposure to light.

Duration of treatment

Since clinical experience with long-term use of Lipoplus is limited, this medicinal product should not be administered for a period longer than one week. If parenteral nutrition with oil emulsions is still indicated, Lipoplus can be administered for longer periods if adequate monitoring is used.

Infusion rate

The infusion should be administered at the lowest possible infusion rate. During the first 15 minutes, the infusion rate used 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 newborn premature infants, newborn full-term infants, infants, and small 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 can interfere with certain laboratory tests (such as bilirubin, lactate dehydrogenase, oxygen saturation) when blood samples are taken before the lipids have been eliminated from the bloodstream, which may require between 4 and 6 hours.

Incompatibilities

Without compatibility studies, this medicinal product should not be mixed with other products.

Valid period after mixing compatible additives

From a microbiological point of view, the product should be used immediately after mixing the additives. If not used immediately after mixing the additives, the storage times and conditions during use before use are the responsibility of the user.

To see the complete information for this product, consult the Technical Data Sheet or Summary of Product Characteristics of Lipoplus 20%.

Warnings and special precautions for use

Exposure to light of parenteral nutrition solutions for intravenous administration, especially after mixing with oligoelements 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 newborns and children under 2 years, Lipoplus 20% should be protected from ambient light until the end of administration.