Lipoflex Plus emulsion for infusion EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Lipoflex plus emulsion for infusion EFG
Read all of this leaflet carefully before you start using 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, pharmacist or nurse.
- 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, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of this leaflet
- What Lipofex plus is and what it is used for
- What you need to know 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 called amino acids, electrolytes, and fatty acids that are essential for growth or recovery of the body. It also provides calories in the form of carbohydrates and fats.
This medicine is administered when there is an inability to take food normally. There are many situations in which this may occur, for example, during recovery phases following surgical procedures, trauma, or burns, or when there is an inability to absorb food in the stomach and intestine.
This emulsion can be administered to adults, adolescents, and children over 2 years of age.
2. What you need to know before using Lipoflex plus
Do not use Lipoflex plus
• if you are allergic to any of the active substances, to egg, peanut, or soy, or to any of the other components of this medicine (listed in section 6),
• this medicine must not be administered to newborns, infants, or children under two years of age.
Also, do not use this medicine if you have any of the following conditions:
• potentially life-threatening circulatory problems, such as those that may occur in cases of collapse or shock,
• myocardial infarction or stroke,
• severe coagulation disorders, risk of bleeding (severe coagulopathy, aggravating hemorrhagic diathesis),
• blockage of blood vessels by blood clots or fat (embolism),
• severe liver failure,
• impaired bile flow (intrahepatic cholestasis),
• severe renal failure when dialysis equipment is not available,
• disturbances in the body's electrolyte composition,
• fluid deficiency or excess water in your body,
• fluid in your lungs (pulmonary edema),
• severe heart failure,
• certain metabolic disorders such as:
- too many lipids (fats) in the blood,
- congenital amino acid metabolism disorders,
- abnormally high blood sugar levels requiring more than 6 units of insulin per hour to be controlled,
- metabolic disturbances that may occur after surgery or trauma,
- coma of unknown origin,
- inadequate oxygen supply to tissues,
- abnormally high levels of acid in the blood.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before starting to use Lipoflex plus.
Inform your doctor if:
• you have heart, liver, or kidney problems,
• you have certain types of metabolic disorders such as diabetes, abnormal blood lipid levels, or disturbances in the body's fluid, electrolyte, or acid-base balance.
You will be closely monitored for early signs of an allergic reaction (such as fever, chills, rash, or shortness of breath) while receiving this medicine.
Additional monitoring and tests, such as various blood tests, will be performed to ensure your body is properly assimilating the administered nutrients.
The nursing staff may also take measures to ensure your body's fluid and electrolyte needs are met. In addition to this medicine, you may receive supplementary nutrients (food) to fully meet your requirements.
Children
This medicine must not be administered to newborns, infants, or children under two years of age.
Use of Lipoflex plus with other medicines
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines.
Lipoflex plus may interact with certain medicines. Inform your doctor, pharmacist, or nurse if you are taking or receiving any of the following medicines:
• insulin,
• heparin,
• medicines that prevent unwanted blood clotting, such as warfarin or other coumarin derivatives,
• medicines that promote urine flow (diuretics),
• medicines for treating high blood pressure (ACE inhibitors),
• medicines for treating high blood pressure or heart problems (angiotensin-II receptor antagonists),
• medicines used in organ transplantation, such as cyclosporine and tacrolimus,
• medicines for treating inflammation (corticosteroids),
• hormonal preparations affecting your fluid balance (adrenocorticotropic hormone or ACTH).
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. If you are pregnant, you will only receive this medicine if your doctor or pharmacist considers it absolutely necessary for your recovery. There are no available data on the use of Lipoflex plus in pregnant women.
Breastfeeding is not recommended in mothers receiving parenteral nutrition.
Driving and use of machines
This medicine is usually administered to immobilized patients, e.g., in a hospital or clinic, which excludes the possibility of driving or operating machinery. However, the medicine itself has no effect on the ability to drive or operate machinery.
Lipoflex plus contains sodium
This medicine contains 1,150 mg of sodium (main component of table/cooking salt) in each 1,250 ml bag. This corresponds to 58% of the maximum daily sodium intake recommended for an adult.
The maximum recommended daily dose of this medicine contains 2,580 mg of sodium (present in table salt). This corresponds to 129% of the maximum daily sodium intake recommended for an adult.
Consult your doctor or pharmacist if you require one or more bags per day for a prolonged period, especially if you have been advised to follow a low-salt (low-sodium) diet.
3. How to use Lipoflex plus
This medicine is administered by intravenous infusion (drop by drop), i.e., through a small tube directly into a vein. This medicine will only be administered through one of your large (central) veins.
Your doctor or pharmacist will decide the dose of this medicine you require and how long you will need treatment with it.
Use in children
This medicine must not be administered to newborns, infants, and young children under two years of age.
Your doctor will decide the dose of this medicine required by your child and how long your child will need treatment with this medicine.
If you use more Lipoflex plus than you should
If you have received too much of this medicine, you may experience the so-called "overload syndrome" and the following symptoms:
• Excess fluid and electrolyte disturbances,
• Fluid in the lungs (pulmonary edema),
• Loss of amino acids through urine and disturbances in amino acid balance,
• Vomiting, nausea,
• Chills,
• High blood sugar levels,
• Glucose in urine,
• Fluid deficit,
• Blood much more concentrated than normal (hyperosmolality),
• Impaired or loss of consciousness due to extremely high blood sugar levels,
• Enlargement of the liver (hepatomegalia), with or without jaundice,
• Enlargement of the spleen (splenomegalia),
• Fat deposition in internal organs,
• Abnormal liver function test results,
• Reduced red blood cell count (anemia),
• Reduced white blood cell count (leukopenia),
• Reduced platelet count (thrombocytopenia),
• Increase in immature red blood cells (reticulocytosis),
• Breakdown of blood cells (hemolysis),
• Bleeding or tendency to bleed,
• Blood coagulation disorders (as evidenced by changes in bleeding time, coagulation time, prothrombin time, etc.),
• Fever,
• High levels of fats in the blood,
• Loss of consciousness.
If any of the following symptoms occur, the infusion must be stopped immediately.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
The following adverse effects may be serious. If you experience any of the following, inform your doctor immediately, who will stop administering this medicine to you:
Rare (may affect up to 1 in 1,000 people):
? allergic reactions such as skin reactions, dyspnea, swelling of the lips, mouth and throat, difficulty breathing,
Other adverse effects include:
Uncommon (may affect up to 1 in 100 people):
? nausea, vomiting, loss of appetite,
Rare (may affect up to 1 in 1,000 people):
? increased tendency for blood to clot,
? bluish discoloration of the skin,
? dyspnea,
? headache,
? flushing,
? redness of the skin (erythema),
? sweating,
? chills,
? feeling cold,
? high body temperature,
? drowsiness,
? chest, back, bone or lumbar pain,
? decrease or increase in blood pressure.
Very rare (may affect up to 1 in 10,000 people):
? abnormally high levels of sugar or fat in the blood,
? elevated levels of acidic substances in the blood,
? excess lipids may cause overload syndrome; for further information see section 3 under “If you use more Lipoflex plus than you should”. Symptoms usually resolve when the infusion is stopped.
Frequency not known (cannot be estimated from available data):
? decrease in white blood cell count (leukopenia),
? decrease in platelet count (thrombocytopenia),
? disturbances in bile flow (cholestasis).
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products (www.notificaRAM.es).
5. Storage of Lipoflex plus
Keep this medicine out of the sight and reach of children.
Do not store above 25 °C.
Do not freeze. Discard the bag if it has been accidentally frozen.
Keep the bag in the outer packaging to protect it from light.
Do not use this medicine after the expiry date stated on the label. The expiry date is the last day of the month indicated.
6. Contents of the container and additional information
Composition of Lipoflex plus
The active ingredients of the ready-to-use mixture are:
From the upper chamber (glucose solution) | in 1,000 ml | in 1,250 ml | in 1,875 ml | in 2,500 ml |
Glucose monohydrate | 132.0 g | 165.0 g | 247.5 g | 330.0 g |
equivalent to glucose | 120.0 g | 150.0 g | 225.0 g | 300.0 g |
Sodium 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 the middle chamber (fat emulsion) | in 1,000 ml | in 1,250 ml | in 1,875 ml | in 2,500 ml |
Refined 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 the lower chamber (amino acid solution) | in 1,000 ml | in 1,250 ml | in 1,875 ml | in 2,500 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 equivalent to lysine | 2.728 g | 3.410 g | 5.115 g | 6.820 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 equivalent to histidine | 1.624 g | 2.030 g | 3.045 g | 4.060 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 1,000 ml | in 1,250 ml | in 1,875 ml | in 2,500 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 |
Lipid content | 40 g | 50 g | 75 g | 100 g |
Energy from lipids | 1,590 kJ (380 kcal) | 1,990 kJ (475 kcal) | 2,985 kJ (715 kcal) | 3,980 kJ (950 kcal) |
Energy from carbohydrates | 2,010 kJ (480 kcal) | 2,510 kJ (600 kcal) | 3,765 kJ (900 kcal) | 5,020 kJ (1,200 kcal) |
Energy from amino acids | 635 kJ | 800 kJ | 1,200 kJ (285 kcal) | 1,600 kJ (380 kcal) |
Non-protein energy | 3,600 kJ (860 kcal) | 4,500 kJ (1,075 kcal) | 6,750 kJ (1,615 kcal) | 9,000 kJ (2,150 kcal) |
Total energy | 4,235 kJ (1,010 kcal) | 5,300 kJ | 7,950 kJ (1,900 kcal) | 10,600 kJ (2,530 kcal) |
Osmolality | 1,540 mOsm/kg | 1,540 mOsm/kg | 1,540 mOsm/kg | 1,540 mOsm/kg |
Theoretical osmolarity | 1,215 mOsm/l | 1,215 mOsm/l | 1,215 mOsm/l | 1,215 mOsm/l |
pH | 5.0–6.0 | 5.0–6.0 | 5.0–6.0 | 5.0–6.0 |
The other components are citric acid monohydrate (for pH adjustment), injectable egg phospholipids, glycerol, sodium oleate, all-rac-alpha-tocopherol and water for injections.
Appearance of the product and contents of the pack
The ready-to-use product is an infusion emulsion, meaning it is administered through a small tube into a vein.
Lipoflex plus is supplied in flexible multi-chamber bags containing:
- 1,250 ml (500 ml amino acid solution + 250 ml fat emulsion + 500 ml glucose solution),
- 1,875 ml (750 ml amino acid solution + 375 ml fat emulsion + 750 ml glucose solution),
- 2,500 ml (1,000 ml amino acid solution + 500 ml fat emulsion + 1,000 ml glucose solution).
Figure A Figure B
Figure A: The multi-chamber bag is enclosed in a protective overwrap. Between the bag and the overwrap are an oxygen absorber and an oxygen indicator; the oxygen absorber sachet is made of inert material and contains iron hydroxide.
Figure B: The upper chamber contains a glucose solution, the middle chamber contains a fat emulsion and the lower chamber contains an amino acid solution.
The glucose and amino acid solutions are clear and colourless to pale yellow in appearance. The fat emulsion is milky white in colour.
The upper and middle chambers can be connected to the lower chamber by opening the intermediate seals (peelable seals).
The bag design allows mixing of amino acids, glucose, lipids and electrolytes into a single chamber. Opening the peelable seals creates a sterile mixture forming an emulsion.
Different pack sizes are available in cartons containing five bags.
Pack sizes: 5 x 1,250 ml, 5 x 1,875 ml and 5 x 2,500 ml
Only certain pack sizes may be marketed.
Marketing Authorisation Holder:
- Braun Melsungen AG
Carl-Braun-Str. 1 Postal address:
34212 Melsungen, Germany 34209 Melsungen, Germany
Tel.: +49-(0)-5661-71-0
Fax: +49-(0)-5661-71-4567
Manufacturer:
- Braun Melsungen AG
Am Schwerzelshof 1
34 212 Melsungen
Germany
Further information about this medicinal product is available from the local representative of the Marketing Authorisation Holder
- Braun Medical, S.A.
Ctra. de Terrassa, 121
08191 Rubí, Spain
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
Belgium Nutriflex Lipid plus, 38 g/l AA + 120 g/l G, emulsie voor infusie
Denmark Lipoflex Plus
Finland Nutriflex Lipid 38/120/40
France LIPOFLEX LIPIDE G120/N 5,4 /E, émulsion pour perfusion
Germany Nutriflex Lipid 38/120 plus
Iceland Nutriflex Lipid 38/120 plus
Italy Lipoflex AA38/G120
Luxembourg Nutriflex Lipid 38/120 plus
Netherlands Nutriflex Lipid plus, 38 g/l + 120 g/l, emulsie voor infusie
Norway Lipoflexplus
Poland Lipoflex plus
Romania Lipoflex plus emulsie perfuzabila
Spain Lipoflex plus emulsión para perfusión
Sweden Nutriflex Lipid 38/120/40
United Kingdom
(Northern Ireland) Lipoflex plus emulsion for infusion
Date of the most recent review of this summary:
09/2023
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)
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This information is intended for healthcare professionals only:
No special requirements for disposal.
Parenteral nutrition products should be inspected visually before use for damage, colour changes and emulsion instability.
Do not use bags showing damage. The overwrap, main bag and peelable seals between chambers must be intact. Use only if the amino acid and glucose solutions are clear and colourless to pale yellow and if the lipid emulsion is homogeneous and milky white. Do not use if the solutions contain particles.
After mixing the three chambers, do not use if the emulsion shows discolouration or signs of phase separation (oil droplets, oil layer). Immediately stop the infusion if discolouration or phase separation occurs.
Before opening the overwrap, check the colour of the oxygen indicator (see Figure A). Do not use if the oxygen indicator turns pink. Use only if the oxygen indicator is yellow.
Preparation of the mixed emulsion
Strict adherence to aseptic handling principles is required.
To open: tear the overwrap starting at the tear notches (Fig. 1). Remove the bag from its protective overwrap. Discard the overwrap, oxygen indicator and oxygen absorber.
Visually inspect the main bag for leaks. Bags with leaks must be discarded, as sterility cannot be guaranteed.
Mixing the bag and addition of additives
To open and mix the chambers sequentially, roll the bag with both hands, first opening the peelable seal separating the upper chamber (glucose) from the lower chamber (amino acids) (Fig. 2).
After removal of the aluminium seal (Fig. 3), compatible water-soluble additives may be added via the medication port (Fig. 4) to the clear aqueous solutions. Mix the bag contents thoroughly (Fig. 5) and visually inspect the mixture for precipitates (Fig. 6). Only use the solution if it is clear.
Next, continue applying pressure so that the peelable seal separating the middle chamber (lipids) from the lower chamber opens (Fig. 7). The resulting mixture is a homogeneous oil-in-water emulsion, milky white in colour. Once all chambers have been mixed, compatible additives may be added via the medication port (Fig. 4). Mix the bag contents thoroughly (Fig. 8) and visually inspect the mixture (Fig. 9).
The manufacturer can provide, upon request, compatibility data for various additives (e.g., electrolytes, trace elements, vitamins) and the corresponding shelf lives of such mixtures.
Preparation for infusion
The emulsion must always be brought to room temperature before infusion.
Remove the aluminium foil (Fig. 10) from the infusion port and connect the infusion set (Fig. 11). Use an infusion set without an air vent or close the air vent if using a vented set. Hang the bag on an infusion hook (Fig. 12) and administer by standard technique.
For single use only. The container and unused waste must be disposed of after use.
Do not reconnect partially used containers.
If filters are used, they must be lipid-permeable (pore size ≥ 1.2 µm).
Shelf life after removal of the protective overwrap and after mixing the bag contents
Chemical and physicochemical stability of the amino acid, glucose and lipid mixture during use has been demonstrated for 7 days at 2–8 °C and for an additional 2 days at 25 °C.
Shelf life after additional mixing of compatible additives
From a microbiological standpoint, the product should be used immediately after mixing with additional compatible additives. Otherwise, the in-use storage times and conditions prior to use are the responsibility of the user.
The emulsion must be used immediately after opening the container.
The recommended duration for infusion of one parenteral nutrition bag is a maximum of 24 hours.
This medicinal product must not be mixed with other medicinal products whose compatibility has not been documented.
This medicinal product must not be administered simultaneously with blood through the same infusion set due to the risk of pseudoagglutination.