Lipoflex Special emulsion for infusion EFG
Spain
Table of Contents
- Package leaflet: Information for the user
- Introduction
- 1. What Lipoflex special is and what it is used for
- 2. What you need to know before using Lipoflex special
- 3. How to use Lipoflex special
- 4. Possible adverse effects
- 5. Storage of Lipoflex special
- 6. Contents of the package and other information
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Lipoflex special emulsion for infusion EFG
Read the entire 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, consult 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 these are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Lipoflex special is and what it is used for
- What you need to know before using Lipoflex special
- How to use Lipoflex special
- Possible side effects
- How to store Lipoflex special
- Contents of the pack and other information
1. What Lipoflex special is and what it is used for
Lipoflex special 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 after 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 special
Do not use Lipoflex special
• if you are allergic to any of the active substances, to egg, peanut, or soy, or to any of the other ingredients 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 occurring in cases of collapse or shock,
• myocardial infarction or cardiovascular accident,
• severe coagulation disorders, risk of bleeding (severe coagulopathy, worsening hemorrhagic diathesis),
• blockage of blood vessels due to 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 deficit or excess water in your body,
• fluid in your lungs (pulmonary edema),
• severe heart failure,
• certain metabolic disorders such as:
- excessive 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 abnormalities 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 special.
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, skin 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 metabolizing the nutrients provided.
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 special 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 special may interact with certain medicines. Inform your doctor, pharmacist, or nurse if you are taking or receiving any of the following:
• 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 plan 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 special in pregnant women.
Breastfeeding is not recommended for mothers receiving parenteral nutrition.
Driving and using machines
This medicine is typically administered to immobilized patients, e.g., in a hospital or clinic setting, 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 special contains sodium
This medicine contains 771 mg of sodium (main component of table/cooking salt) in each 625 ml bag. This corresponds to 39% of the maximum daily sodium intake recommended for an adult.
The maximum recommended daily dose of this medicine contains 3,020 mg of sodium (present in table salt). This corresponds to 151% of the maximum daily sodium intake recommended for an adult.
Consult your doctor or pharmacist if you require one or more bags per day over a prolonged period, especially if you have been advised to follow a low-salt (low-sodium) diet.
3. How to use Lipoflex special
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 how much of this medicine you need and how long you will require 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 how much of this medicine your child needs and for how long your child will require treatment with this medicine.
If you use more Lipoflex special 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 imbalances,
? 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 consciousness or loss of consciousness due to extremely high sugar levels,
? Enlargement of the liver (hepatomegaly) with or without jaundice,
? Enlargement of the spleen (splenomegaly),
? 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 lipids 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 experiences 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 (affects between 1 and 10 users in 10,000):
? increased tendency of blood to clot,
? bluish discoloration of the skin,
? dyspnea,
? headache,
? flushing,
? skin redness (erythema),
? sweating,
? chills,
? feeling of 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 your blood,
? excess lipids may cause the overload syndrome; for further information, refer to the section “If you use more Lipoflex special than you should” in section 3. Symptoms usually disappear 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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicines (www.notificaRAM.es).
5. Storage of Lipoflex special
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. Store 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 package and other information
Composition of Lipoflexspecial
The active ingredients of the ready-to-use mixture are:
From the upper chamber (glucose solution) | in 1,000 ml | in 625 ml | in 1,250 ml | in 1,875 ml |
Glucose monohydrate | 158.4 g | 99.00 g | 198.0 g | 297.0 g |
equivalent to glucose | 144.0 g | 90.00 g | 180.0 g | 270.0 g |
Sodium dihydrogen phosphate dihydrate | 2.496 g | 1.560 g | 3.120 g | 4.680 g |
Zinc acetate dihydrate | 7.024 mg | 4.390 mg | 8.780 mg | 13.17 mg |
From the middle chamber (fat emulsion) | in 1,000 ml | in 625 ml | in 1,250 ml | in 1,875 ml |
Refined soybean oil | 20.00 g | 12.50 g | 25.00 g | 37.50 g |
Medium-chain triglycerides | 20.00 g | 12.50 g | 25.00 g | 37.50 g |
From the lower chamber (amino acid solution) | in 1,000 ml | in 625 ml | in 1,250 ml | in 1,875 ml |
Isoleucine | 3.284 g | 2.053 g | 4.105 g | 6.158 g |
Leucine | 4.384 g | 2.740 g | 5.480 g | 8.220 g |
Lysine hydrochloride equivalent to lysine | 3.980 g | 2.488 g | 4.975 g | 7.463 g |
Methionine | 2.736 g | 1.710 g | 3.420 g | 5.130 g |
Phenylalanine | 4.916 g | 3.073 g | 6.145 g | 9.218 g |
Threonine | 2.540 g | 1.588 g | 3.175 g | 4.763 g |
Tryptophan | 0.800 g | 0.500 g | 1.000 g | 1.500 g |
Valine | 3.604 g | 2.253 g | 4.505 g | 6.758 g |
Arginine | 3.780 g | 2.363 g | 4.725 g | 7.088 g |
Monohydrate histidine hydrochloride equivalent to histidine | 2.368 g | 1.480 g | 2.960 g | 4.440 g |
Alanine | 6.792 g | 4.245 g | 8.490 g | 12.73 g |
Aspartic acid | 2.100 g | 1.313 g | 2.625 g | 3.938 g |
Glutamic acid | 4.908 g | 3.068 g | 6.135 g | 9.203 g |
Glycine | 2.312 g | 1.445 g | 2.890 g | 4.335 g |
Proline | 4.760 g | 2.975 g | 5.950 g | 8.925 g |
Serine | 4.200 g | 2.625 g | 5.250 g | 7.875 g |
Sodium hydroxide | 1.171 g | 0.732 g | 1.464 g | 2.196 g |
Sodium chloride | 0.378 g | 0.237 g | 0.473 g | 0.710 g |
Sodium acetate trihydrate | 0.250 g | 0.157 g | 0.313 g | 0.470 g |
Potassium acetate | 3.689 g | 2.306 g | 4.611 g | 6.917 g |
Magnesium acetate tetrahydrate | 0.910 g | 0.569 g | 1.137 g | 1.706 g |
Calcium chloride dihydrate | 0.623 g | 0.390 g | 0.779 g | 1.169 g |
Electrolytes | in 1,000 ml | in 625 ml | in 1,250 ml | in 1,875 ml |
Sodium | 53.6 mmol | 33.5 mmol | 67 mmol | 100.5 mmol |
Potassium | 37.6 mmol | 23.5 mmol | 47 mmol | 70.5 mmol |
Magnesium | 4.2 mmol | 2.65 mmol | 5.3 mmol | 7.95 mmol |
Calcium | 4.2 mmol | 2.65 mmol | 5.3 mmol | 7.95 mmol |
Zinc | 0.03 mmol | 0.02 mmol | 0.04 mmol | 0.06 mmol |
Chloride | 48 mmol | 30 mmol | 60 mmol | 90 mmol |
Acetate | 48 mmol | 30 mmol | 60 mmol | 90 mmol |
Phosphate | 16 mmol | 10 mmol | 20 mmol | 30 mmol |
Amino acid content | 56.0 g | 35.0 g | 70.1 g | 105.1 g |
Nitrogen content | 8 g | 5 g | 10 g | 15 g |
Carbohydrate content | 144 g | 90 g | 180 g | 270 g |
Lipid content | 40 g | 25 g | 50 g | 75 g |
Energy from lipids | 1,590 kJ (380 kcal) | 995 kJ (240 kcal) | 1,990 kJ (475 kcal) | 2,985 kJ (715 kcal) |
Energy from carbohydrates | 2,415 kJ (575 kcal) | 1,510 kJ (360 kcal) | 3,015 kJ (720 kcal) | 4,520 kJ (1,080 kcal) |
Energy from amino acids | 940 kJ | 585 kJ | 1,170 kJ (280 kcal) | 1,755 kJ (420 kcal) |
Non-protein energy | 4,005 kJ (955 kcal) | 2,505 kJ (600 kcal) | 5,005 kJ (1,195 kcal) | 7,505 kJ (1,795 kcal) |
Total energy | 4,945 kJ (1,180 kcal) | 3,090 kJ | 6,175 kJ (1,475 kcal) | 9,260 kJ (2,215 kcal) |
Osmolality | 2,115 mOsm/kg | 2,115 mOsm/kg | 2,115 mOsm/kg | 2,115 mOsm/kg |
Theoretical osmolarity | 1,545 mOsm/l | 1,545 mOsm/l | 1,545 mOsm/l | 1,545 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-α-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 inserted into a vein.
Lipoflex special is supplied in flexible multi-chamber bags containing:
- 625 ml (250 ml amino acid solution + 125 ml fat emulsion + 250 ml glucose solution),
- 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).
Figure A Figure B
Figure A: The multi-chamber bag is enclosed in a protective wrapper. Between the bag and the wrapper 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.
The upper and middle chambers can be connected to the lower chamber by opening the intermediate seams (peelable seals).
The bag design allows mixing of amino acids, glucose, lipids and electrolytes in 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 × 625 ml, 5 × 1,250 ml and 5 × 1,875 ml
Only certain pack sizes may be marketed.
Marketing Authorization 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
34212 Melsungen, Germany
Further information on this medicinal product is available upon request to the local representative of the Marketing Authorization Holder
- Braun Medical, S.A.
Ctra. de Terrassa, 121
08191 Rubí, Spain
This medicinal product is authorized in the European Economic Area member states and in the United Kingdom (Northern Ireland) under the following names:
Austria Nutriflex Lipid special B.Braun
Belgium Nutriflex Lipid special, 56 g/l AA + 144 g/l G, emulsie voor infusie
Denmark Lipoflex special
Finland Nutriflex Lipid 56/144/40
France LIPOFLEX LIPIDE G144/N8/E, émulsion pour perfusion
Germany Nutriflex Lipid 56/144 special
Iceland Nutriflex Lipid 56/144 special
Italy Lipoflex, AA56 / G144
Luxembourg Nutriflex Lipid 56/144 special
Netherlands Nutriflex Lipid special, 56 g/l + 144 g/l emulsie voor infusie
Norway Lipoflex special
Poland Lipoflex special
Spain Lipoflex special emulsión para perfusión
Sweden Nutriflex Lipid 56/144/40
United Kingdom
(Northern Ireland) Lipoflex special emulsion for infusion
Date of latest review of this leaflet:
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/)
______________________________________________________________________________
This information is intended for healthcare professionals only:
No special conditions for disposal are required.
Parenteral nutrition products should be visually inspected before use for damage, colour changes and emulsion instability.
Do not use bags showing damage. The wrapper, 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 solutions contain particles.
After mixing the three chambers, do not use if the emulsion shows colour change or signs of phase separation (oil droplets, oil layer). Immediately stop infusion in case of colour change of the emulsion or signs of phase separation.
Before opening the wrapper, check the colour of the oxygen indicator (see Figure A). Do not use if the oxygen indicator has turned pink. Use only if the oxygen indicator is yellow.
Preparation of the mixed emulsion
Strict adherence to aseptic handling principles must be observed.
To open: tear the wrapper starting at the notches (Fig. 1). Remove the bag from its protective wrapper. Discard the wrapper, oxygen indicator and oxygen absorber.
Visually inspect the main bag for leaks. Discard bags with leaks, 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 removing 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). Use the solution only if it is clear.
Next, continue applying pressure to open the peelable seal separating the middle chamber (lipids) from the lower chamber (Fig. 7). The resulting mixture is a homogeneous oil-in-water emulsion with a milky white appearance. After 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 film (Fig. 10) from the infusion port and connect the infusion set (Fig. 11). Use an infusion set without 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 infusion 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 wrapper and after mixing the bag contents
Chemical and physicochemical stability of the mixture of amino acids, glucose and lipids 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 additional mixing with additives. Otherwise, the 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 a 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.