Lipoflex plus
Poland
Table of Contents
- Package leaflet: Information for the user
- 1. What Lipoflex plus is and what it is used for
- 2. Important information before using Lipoflex plus
- 3. How to use Lipoflex plus
- 4. Possible adverse reactions
- 5. How to store Lipoflex plus
- 6. Contents of the package and other information
- Information intended exclusively for medical professionals:
Package leaflet: Information for the user
Lipoflex plus, infusion emulsion
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.
- Keep this leaflet, so that you can read it again if necessary.
- If you have any questions, ask your doctor, pharmacist, or nurse.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
- If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
Contents of the leaflet
- What Lipoflex plus is and what it is used for
- Important information before using Lipoflex plus
- How to use Lipoflex plus
- Possible side effects
- How to store Lipoflex plus
- Contents of the pack and other information
1. What Lipoflex plus is and what it is used for
Lipoflex plus contains fluids and substances—amino acids, electrolytes, and fatty acids—necessary for body growth or regeneration. It also provides calories in the form of carbohydrates and fats.
This medicine is given to patients who cannot be fed orally. There are many situations in which this may occur, for example, postoperatively, after trauma or burns, or when a patient has difficulty absorbing nutrients from the stomach or intestines.
This infusion emulsion can be administered to adults, adolescents, and children over 2 years of age.
2. Important information before using Lipoflex plus
When not to use Lipoflex plus
- If the patient is allergic to the active substances, egg protein, peanuts, soy, or any of the other ingredients of this medicine (listed in section 6).
- This medicine must not be given to newborns, infants, or children under two years of age.
This medicine should also not be used in the following cases:
- Life-threatening circulatory disturbances occurring during collapse or shock,
- Myocardial infarction or stroke,
- Severe blood coagulation disorders, risk of bleeding (severe coagulopathy, exacerbation of haemorrhagic diathesis),
- Blockage of blood vessels by blood clots or fat (embolism),
- Severe liver failure,
- Impaired bile flow (intrahepatic cholestasis),
- Severe renal failure without renal replacement therapy,
- Electrolyte imbalances,
- Fluid deficiency or excess water in the body,
- Fluid in the lungs (pulmonary oedema),
- Severe heart failure,
- Certain metabolic disorders, such as:
- Excessively high levels of fats in the blood,
- Inborn errors of amino acid metabolism,
- Abnormally high blood sugar levels requiring more than 6 units of insulin per hour,
- Metabolic disturbances following surgery or trauma,
- Coma of unknown origin,
- Inadequate tissue oxygen supply,
- Abnormally high levels of acids in the blood.
Warnings and precautions
Before starting treatment with Lipoflex plus, discuss this with your doctor, pharmacist, or nurse.
Inform your doctor if:
- The patient has heart, liver, or kidney disorders,
- The patient has specific metabolic disorders such as diabetes, abnormal blood lipid levels, or disturbances in fluid and electrolyte balance or acid-base equilibrium.
While receiving this medicine, the patient will be closely monitored for early signs of allergic reactions (such as fever, chills, rash, or difficulty breathing).
Additional monitoring and laboratory tests, including various blood analyses, will be performed to ensure the patient's body is properly handling the administered nutrients.
The nursing staff may take measures to ensure the patient's body receives adequate fluids and electrolytes. The patient may receive additional nutritional components besides this medicine to fully meet the body's requirements.
Children
This medicine must not be given to newborns, infants, or children under two years of age.
Lipoflex plus and other medicines
Tell your doctor, pharmacist, or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Lipoflex plus may interact with other medicines. The patient should inform the doctor, pharmacist, or nurse if they are taking or receiving any of the following medicines:
- Insulin,
- Heparin,
- Medicines preventing unwanted blood clotting, such as warfarin or other coumarin derivatives,
- Medicines that increase urine production (diuretics),
- Medicines used for high blood pressure (ACE inhibitors),
- Medicines used for high blood pressure or heart disorders (angiotensin II receptor antagonists),
- Medicines used in organ transplantation, such as cyclosporine and tacrolimus,
- Medicines used in the treatment of inflammatory conditions (corticosteroids),
- Hormonal medicines affecting fluid balance (adrenocorticotropic hormone or ACTH).
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine. If the patient is pregnant, she will receive this medicine only if the doctor or pharmacist considers it absolutely necessary for her recovery. There are no available data on the use of Lipoflex plus in pregnant women.
Breastfeeding is not recommended for mothers receiving parenteral nutrition.
Driving and operating machinery
This medicine is usually administered to immobilized patients, for example in hospital or clinic settings, which excludes driving and operating machinery. However, the medicine itself does not affect the ability to drive or operate machinery.
Lipoflex plus contains sodium
This medicine contains 1150 mg of sodium (the main component of table salt) in each 1250 ml bag. This corresponds to 58% of the maximum recommended daily dietary sodium intake for adults.
The maximum recommended daily dose of this medicinal product contains 2580 mg of sodium (main component of table salt). This corresponds to 129% of the maximum recommended daily dietary sodium intake for adults.
If one or more bags are administered daily over a prolonged period, patients—especially those monitoring their dietary sodium intake—should consult their doctor or pharmacist.
3. How to use Lipoflex plus
The medicine is administered as an intravenous infusion (drip), via a small tube directly into a vein. The medicine is given only through larger (central) veins.
The dose will be determined by your doctor or pharmacist, who will also decide how long the treatment should continue.
Use in children
Lipoflex plus must not be given to newborns, infants, or children under two years of age.
The doctor will determine the appropriate dose for a child and how long the treatment should last.
Administration of a higher than recommended dose of Lipoflex plus
If too much of this medicine is administered, the patient may develop an overload syndrome with the following symptoms:
- excess body fluids and electrolyte imbalance,
- fluid in the lungs (pulmonary edema),
- loss of amino acids in urine and disturbed amino acid balance,
- vomiting, nausea,
- chills,
- high blood sugar levels,
- glucose in urine,
- fluid deficiency,
- significantly increased osmolarity of blood components (hyperosmolality),
- impaired or lost consciousness due to very high blood sugar levels,
- enlarged liver (hepatomegaly) with or without jaundice,
- enlarged spleen (splenomegality),
- fat deposition in internal organs,
- abnormal liver function test results,
- reduced number of red blood cells (anemia),
- reduced number of white blood cells (leukopenia),
- reduced platelet count (thrombocytopenia),
- increased number of immature red blood cells (reticulocytosis),
- breakdown of red blood cells (hemolysis),
- bleeding or tendency to bleed,
- blood coagulation disorders (manifested by changes in bleeding time, clotting time, prothrombin time, etc.),
- fever,
- high blood fat levels,
- loss of consciousness.
If any of the above symptoms occur, the infusion must be stopped immediately.
Should you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may be serious. If any of the following
adverse reactions occur, inform your doctor immediately, who will discontinue
the administration of the medicine:
Rare (may occur in 1 out of 1,000 people):
- allergic reactions, such as skin reactions, shortness of breath, swelling of the lips, mouth and throat, difficulty breathing.
Other adverse reactions include:
Uncommon (may occur in 1 out of 100 people):
- nausea, vomiting, loss of appetite.
Rare (may occur in 1 out of 1,000 people):
- increased blood coagulability,
- bluish discoloration of the skin,
- shortness of breath,
- headache,
- hot flushes,
- skin redness (erythema),
- sweating,
- chills,
- feeling cold,
- elevated body temperature,
- drowsiness,
- chest pain, back pain, bone pain and lower back pain,
- decreased or increased blood pressure.
Very rare (may occur in 1 out of 10,000 people):
- abnormally high levels of fat or sugar in the blood,
- high levels of acidic substances in the blood,
- excessive fat levels may lead to fat overload syndrome; more information on this, see “Use of a higher than recommended dose of Lipoflex plus”, section 3. Symptoms usually resolve after stopping the infusion.
Unknown frequency (cannot be estimated from available data):
- decreased number of white blood cells (leukopenia),
- decreased number of platelets (thrombocytopenia),
- disturbances in bile flow (cholestasis).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, tell your doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, more information on the safety of the medicine can be collected.
5. How to store Lipoflex plus
Keep this medicine out of sight and reach of children.
Do not store above 25°C.
Do not freeze. If accidental freezing occurs, discard the bag.
Store in the outer protective pouch to protect from light.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the stated month.
6. Contents of the package and other information
What Lipoflex plus contains
The active substances contained in the ready-to-use mixture are:
| From upper chamber (glucose solution) | in 1000 ml | in 1250 ml | in 1875 ml | in 2500 ml |
| Glucose monohydrate corresponding to glucose | 132.0 g 120.0 g | 165.0 g 150.0 g | 247.5 g 225.0 g | 330.0 g 300.0 g |
| Disodium dihydrogen phosphate dihydrate | 1.872 g | 2.340 g | 3.510 g | 4.680 g |
| Zinc acetate dihydrate | 5.264 mg | 6.580 mg | 9.870 mg | 13.16 mg |
| From middle chamber (fat emulsion) | in 1000 ml | in 1250 ml | in 1875 ml | in 2500 ml |
| Purified soybean oil | 20.00 g | 25.00 g | 37.50 g | 50.00 g |
| Medium-chain triglycerides | 20.00 g | 25.00 g | 37.50 g | 50.00 g |
| From lower chamber (amino acid solution) | in 1000 ml | in 1250 ml | in 1875 ml | in 2500 ml |
| Isoleucine | 2.256 g | 2.820 g | 4.230 g | 5.640 g |
| Leucine | 3.008 g | 3.760 g | 5.640 g | 7.520 g |
| Lysine hydrochloride corresponding to lysine | 2.728 g 2.184 g | 3.410 g 2.729 g | 5.115 g 4.094 g | 6.820 g 5.459 g |
| Methionine | 1.880 g | 2.350 g | 3.525 g | 4.700 g |
| Phenylalanine | 3.368 g | 4.210 g | 6.315 g | 8.420 g |
| Threonine | 1.744 g | 2.180 g | 3.270 g | 4.360 g |
| Tryptophan | 0.544 g | 0.680 g | 1.020 g | 1.360 g |
| Valine | 2.496 g | 3.120 g | 4.680 g | 6.240 g |
| Arginine | 2.592 g | 3.240 g | 4.860 g | 6.480 g |
| Monohydrate histidine hydrochloride corresponding to histidine | 1.624 g 1.202 g | 2.030 g 1.503 g | 3.045 g 2.255 g | 4.060 g 3.005 g |
| Alanine | 4.656 g | 5.820 g | 8.730 g | 11.64 g |
| Aspartic acid | 1.440 g | 1.800 g | 2.700 g | 3.600 g |
| Glutamic acid | 3.368 g | 4.210 g | 6.315 g | 8.420 g |
| Glycine | 1.584 g | 1.980 g | 2.970 g | 3.960 g |
| Proline | 3.264 g | 4.080 g | 6.120 g | 8.160 g |
| Serine | 2.880 g | 3.600 g | 5.400 g | 7.200 g |
| Sodium hydroxide | 0.781 g | 0.976 g | 1.464 g | 1.952 g |
| Sodium chloride | 0.402 g | 0.503 g | 0.755 g | 1.006 g |
| Sodium acetate trihydrate | 0.222 g | 0.277 g | 0.416 g | 0.554 g |
| Potassium acetate | 2.747 g | 3.434 g | 5.151 g | 6.868 g |
| Magnesium acetate tetrahydrate | 0.686 g | 0.858 g | 1.287 g | 1.716 g |
| Calcium chloride dihydrate | 0.470 g | 0.588 g | 0.882 g | 1.176 g |
| Electrolytes | in 1000 ml | in 1250 ml | in 1875 ml | in 2500 ml |
| Sodium | 40 mmol | 50 mmol | 75 mmol | 100 mmol |
| Potassium | 28 mmol | 35 mmol | 52.5 mmol | 70 mmol |
| Magnesium | 3.2 mmol | 4.0 mmol | 6.0 mmol | 8.0 mmol |
| Calcium | 3.2 mmol | 4.0 mmol | 6.0 mmol | 8.0 mmol |
| Zinc | 0.024 mmol | 0.03 mmol | 0.045 mmol | 0.06 mmol |
| Chloride | 36 mmol | 45 mmol | 67.5 mmol | 90 mmol |
| Acetate | 36 mmol | 45 mmol | 67.5 mmol | 90 mmol |
| Phosphate | 12 mmol | 15 mmol | 22.5 mmol | 30 mmol |
| Amino acid content | 38 g | 48 g | 72 g | 96 g |
| Nitrogen content | 5.4 g | 6.8 g | 10.2 g | 13.7 g |
| Carbohydrate content | 120 g | 150 g | 225 g | 300 g |
| Fat content | 40 g | 50 g | 75 g | 100 g |
| Energy from fat | 1590 kJ (380 kcal) | 1990 kJ (475 kcal) | 2985 kJ (715 kcal) | 3980 kJ (950 kcal) |
| Energy from carbohydrates | 2010 kJ (480 kcal) | 2510 kJ (600 kcal) | 3765 kJ (900 kcal) | 5020 kJ (1200 kcal) |
| Energy from amino acids | 635 kJ (150 kcal) | 800 kJ (190 kcal) | 1200 kJ (285 kcal) | 1600 kJ (380 kcal) |
| Non-protein energy | 3600 kJ (860 kcal) | 4500 kJ (1075 kcal) | 6750 kJ (1615 kcal) | 9000 kJ (2150 kcal) |
| Total energy | 4235 kJ (1010 kcal) | 5300 kJ (1265 kcal) | 7950 kJ (1900 kcal) | 10600 kJ (2530 kcal) |
| Osmolality | 1540 mOsm/kg | 1540 mOsm/kg | 1540 mOsm/kg | 1540 mOsm/kg |
| Theoretical osmolarity | 1215 mOsm/l | 1215 mOsm/l | 1215 mOsm/l | 1215 mOsm/l |
| pH | 5.0 - 6.0 | 5.0 - 6.0 | 5.0 - 6.0 | 5.0 - 6.0 |
The other ingredients are: monohydrate citric acid (for pH adjustment), egg phospholipids for
injection, glycerol, sodium oleate, all- rac -α-Tocopherol and water for injection.
What Lipoflex plus looks like and contents of the pack
The ready-to-use product is an emulsion for infusion, i.e. it is administered through a small tube into
a vein.
Lipoflex plus is supplied in three-compartment bags containing:
- 1250 ml (500 ml amino acid solution + 250 ml lipid emulsion + 500 ml glucose solution)
- 1875 ml (750 ml amino acid solution + 375 ml lipid emulsion + 750 ml glucose solution)
- 2500 ml (1000 ml amino acid solution + 500 ml lipid emulsion + 1000 ml glucose solution)
Figure A Figure B
Figure A: The multi-compartment bag is packed in a protective overwrap. Between the bag and
the protective overwrap, an oxygen absorber and an oxygen indicator are placed; the oxygen-absorbing sachet is made of inert material and contains iron hydroxide.
Figure B: The upper compartment contains glucose solution, the middle compartment contains lipid emulsion,
and the lower compartment contains amino acid solution.
The glucose and amino acid solutions are clear and colourless or slightly yellowish. The lipid emulsion is milky white.
The upper and middle compartments can be connected to the lower compartment by opening the internal seals
(breakable seals).
The bag is designed to allow mixing of amino acids, glucose, lipids and electrolytes in a single compartment. Breaking the seals will result in sterile mixing of the contents and formation of an emulsion.
The product in different bag sizes is available in cardboard packages containing five bags.
Pack sizes: 5 x 1250 ml, 5 x 1875 ml and 5 x 2500 ml
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
B. Braun Melsungen AG
Carl-Braun-Straße 1 Postal address
34212 Melsungen, Germany 34209 Melsungen, Germany
Tel.: +49-(0)-5661-71-0
Fax: +49-(0)-5661-71-4567
This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria Nutriflex Lipid plus B.Braun Emulsion zur Infusion
Belgium Nutriflex Lipid plus, 38 g/l Amino + 120 g/l G, emulsie voor infusie
Denmark Lipoflex plus
Finland Nutriflex Lipid 38/120/40 infuusioneste, emulsio
France MEDNUTRIFLEX E, émulsion pour perfusion
Germany NuTRIflex Lipid plus novo Emulsion zur Infusion
Iceland Nutriflex Lipid 38/120/40 innrennslislyf, fleyti
Italy LIPOFLEX AA38/G120 Emulsione per infusione
Luxembourg NuTRIflex Lipid plus novo Emulsion zur Infusion
Netherlands Nutriflex Lipid plus, 38 g/l Amino + 120 g/l G, emulsie voor infusie
Norway Lipoflex plus infusjonsvæske, emulsjon
Poland Lipoflex plus
Romania NuTRIflex Lipid plus novo, emulsie perfuzabilă
Spain Lipoflex plus emulsión para perfusión EFG
Sweden Nutriflex Lipid 38/120/40 infusionsvätska, emulsion
United Kingdom (Northern Ireland) Lipoflex plus emulsion for infusion
______________________________________________________________________________
Information intended exclusively for medical professionals:
No special requirements for disposal.
Before use, parenteral nutrition products should be visually inspected for
damage, discoloration, or instability of the emulsion.
Do not use bags that are damaged. The outer and inner bag, as well as the seals between compartments, must be intact. The product should be used only if amino acid and glucose solutions are clear and colorless to straw-colored, and the fat emulsion is a uniform milky-white color. Do not use if the solutions contain particulate matter.
After mixing the contents of the three compartments, do not use if the emulsion shows discoloration or signs of phase separation (oil droplets, oil layer). If discoloration or phase separation occurs, infusion must be immediately discontinued.
Before opening the protective packaging, check the oxygen indicator (see Figure A). Do not use if the oxygen indicator has changed color to pink. Use only if the oxygen indicator is yellow.
Preparation of the mixed emulsion
Strictly follow aseptic handling procedures.
To open: tear the protective packaging starting at the perforation points (Fig. 1).
Remove the bag from the protective packaging. Remove the protective packaging, oxygen indicator, and oxygen absorber.
Inspect the bag for leaks. Leaking bags must be discarded due to lack of sterility assurance.
Mixing the bag contents and adding additional substances
To open and mix the contents of the compartments, fold the bag with both hands, starting with breaking the seal between the upper compartment (glucose) and the lower compartment (amino acids) (Fig. 2).
After removing the aluminum cover (Fig. 3), compatible, water-soluble additional substances may be added to the clear aqueous solutions through the medication port (Fig. 4). Mix thoroughly (Fig. 5) and inspect the mixture for precipitates (Fig. 6). Use only clear solutions.
Then continue applying pressure until the seal between the middle compartment (fats) and the lower compartment is broken (Fig. 7). The mixture is a uniform milky-white oil-in-water emulsion. After mixing all compartments, compatible additional substances may be added through the medication port (Fig. 4). Mix thoroughly (Fig. 8) and inspect the mixture (Fig. 9).
Information regarding compatibility of various additional substances (e.g., electrolytes, trace elements, vitamins) and shelf life of such admixtures is available upon request from the manufacturer.
Preparation for infusion
Before infusion, always bring the emulsion to room temperature.
Remove the aluminum foil (Fig. 10) from the infusion port and attach the infusion set (Fig. 11). Use infusion sets without an air vent or, if using sets with an air vent, ensure the vent is closed. Hang the bag on an infusion stand (Fig. 12) and administer the infusion using standard techniques.
For single use only. After use, the container and any unused residue must be discarded. Do not re-connect partially used containers.
If filters are used, they must be fat-compatible (pore size ≥ 1.2 µm).
Shelf life after removal of protective packaging and mixing of bag contents
Chemical and physicochemical stability of the mixture of amino acids, glucose, and fat emulsion has been demonstrated for 7 days when stored at 2–8°C and for an additional 2 days at 25°C prior to use.
Shelf life after addition of compatible additional substances
From a microbiological standpoint, the product should be used immediately after addition of additional substances. The user is responsible for the storage time and conditions if the product is not used immediately after adding additional substances.
The emulsion should be used immediately after opening the container.
The recommended duration of infusion from a single bag in parenteral nutrition is 24 hours.
Do not mix this medicinal product with other medicinal products unless compatibility has been confirmed.
This medicinal product must not be administered simultaneously with blood using the same infusion set due to the risk of pseudoagglutination.