Lipoflex Peri emulsion for infusion EFG
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Lipoflex peri 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 reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
Contents of this leaflet
- What Lipofex peri is and what it is used for
- What you need to know before using Lipoflex peri
- How to use Lipoflex peri
- Possible side effects
- How to store Lipoflex peri
- Contents of the pack and other information
1. What Lipoflex peri is and what it is used for
Lipoflex peri 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, such as 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 peri
Do not use Lipoflex peri
? 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, worsening hemorrhagic diathesis),
? blockage of blood vessels due to blood clots or fat (embolism),
? severe liver failure,
? impaired bile flow (intrahepatic cholestasis),
? 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 control,
- metabolic disturbances that may occur after surgery or trauma,
- coma of unknown origin,
- inadequate oxygen supply to tissues,
- abnormally high levels of acids in the blood.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before starting Lipoflex peri.
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 body fluid and electrolyte composition 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) when 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.
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 peri 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 peri 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 peri in pregnant women.
Breastfeeding is not recommended in mothers receiving parenteral nutrition.
Driving and use of machines
This medicine is normally administered to immobilized patients, e.g., in a hospital or clinic, which excludes the possibility of driving or operating machinery. However, this medicine itself has no effect on the ability to drive or operate machinery.
Lipoflex peri 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 recommended maximum 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 need 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 peri
This medicine is administered by intravenous infusion (drip), that is, through a small tube directly into a vein. This medicine may be given through one of your small (peripheral) veins or through one of your large (central) veins.
Your doctor or pharmacist will decide how much of this medicine you need and how long you require treatment with it.
Use in children
This medicine must not be given to newborns, infants, and young children under two years of age.
Your doctor will decide how much of this medicine your child needs and how long your child requires treatment with it.
If you use more Lipoflex peridel 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 deficiency,
• Blood much more concentrated than normal (hyperosmolality),
• Impaired consciousness or loss of consciousness due to extremely high blood 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 seen by changes in bleeding time, clotting time, prothrombin time, etc.),
• Fever,
• High levels of fat 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 can 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; your doctor will stop administering this medicine to you:
Rare (may affect up to 1 in 1,000 people):
? allergic reactions such as, for example, skin reactions, dyspnea, swelling of the lips, mouth, and throat, difficulty breathing.
Other adverse effects include:
Frequent (may affect up to 1 in 10 people):
? irritation or inflammation of the veins (phlebitis, thrombophlebitis).
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,
? sensation of cold,
? high body temperature,
? somnolence,
? 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 overload syndrome; for further information, refer to the section “If you use more Lipoflex peri 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 through the Spanish System for Pharmacovigilance of Human Medicinal Products (www.notificaRAM.es).
5. Storage of Lipoflex peri
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 Lipoflex peri
The active substances in 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 | 70.40 g | 88.00 g | 132.0 g | 176.0 g |
equivalent to glucose | 64.0 g | 80.00 g | 120.0 g | 160.0 g |
Sodium dihydrogen phosphate dihydrate | 0.936 g | 1.170 g | 1.755 g | 2.340 g |
Zinc acetate dihydrate | 5.280 mg | 6.600 mg | 9.900 mg | 13.20 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 | 1.872 g | 2.340 g | 3.510 g | 4.680 g |
Leucine | 2.504 g | 3.130 g | 4.695 g | 6.260 g |
Lysine hydrochloride equivalent to lysine | 2.272 g | 2.840 g | 4.260 g | 5.680 g |
Methionine | 1.568 g | 1.960 g | 2.940 g | 3.920 g |
Phenylalanine | 2.808 g | 3.510 g | 5.265 g | 7.020 g |
Threonine | 1.456 g | 1.820 g | 2.730 g | 3.640 g |
Tryptophan | 0.456 g | 0.570 g | 0.855 g | 1.140 g |
Valine | 2.080 g | 2.600 g | 3.900 g | 5.200 g |
Arginine | 2.160 g | 2.700 g | 4.050 g | 5.400 g |
Monohydrate histidine hydrochloride equivalent to histidine | 1.352 g | 1.690 g | 2.535 g | 3.380 g |
Alanine | 3.880 g | 4.850 g | 7.275 g | 9.700 g |
Aspartic acid | 1.200 g | 1.500 g | 2.250 g | 3.000 g |
Glutamic acid | 2.800 g | 3.500 g | 5.250 g | 7.000 g |
Glycine | 1.320 g | 1.650 g | 2.475 g | 3.300 g |
Proline | 2.720 g | 3.400 g | 5.100 g | 6.800 g |
Serine | 2.400 g | 3.000 g | 4.500 g | 6.000 g |
Sodium hydroxide | 0.640 g | 0.800 g | 1.200 g | 1.600 g |
Sodium chloride | 0.865 g | 1.081 g | 1.622 g | 2.162 g |
Sodium acetate trihydrate | 0.435 g | 0.544 g | 0.816 g | 1.088 g |
Potassium acetate | 2.354 g | 2.943 g | 4.415 g | 5.886 g |
Magnesium acetate tetrahydrate | 0.515 g | 0.644 g | 0.966 g | 1.288 g |
Calcium chloride dihydrate | 0.353 g | 0.441 g | 0.662 g | 0.882 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 | 24 mmol | 30 mmol | 45 mmol | 60 mmol |
Magnesium | 2.4 mmol | 3.0 mmol | 4.5 mmol | 6.0 mmol |
Calcium | 2.4 mmol | 3.0 mmol | 4.5 mmol | 6.0 mmol |
Zinc | 0.024 mmol | 0.03 mmol | 0.045 mmol | 0.06 mmol |
Chloride | 38 mmol | 48 mmol | 72 mmol | 96 mmol |
Acetate | 32 mmol | 40 mmol | 60 mmol | 80 mmol |
Phosphate | 6.0 mmol | 7.5 mmol | 11.25 mmol | 15.0 mmol |
Amino acid content | 32 g | 40 g | 60 g | 80 g |
Nitrogen content | 4.6 g | 5.7 g | 8.6 g | 11.4 g |
Carbohydrate content | 64 g | 80 g | 120 g | 160 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 | 1,075 kJ (255 kcal) | 1,340 kJ (320 kcal) | 2,010 kJ (480 kcal) | 2,680 kJ (640 kcal) |
Energy from amino acids | 535 kJ | 670 kJ | 1,005 kJ (240 kcal) | 1,340 kJ (320 kcal) |
Non-protein energy | 2,665 kJ (635 kcal) | 3,330 kJ (795 kcal) | 4,995 kJ (1,195 kcal) | 6,660 kJ (1,590 kcal) |
Total energy | 3,200 kJ (765 kcal) | 4,000 kJ | 6,000 kJ (1,435 kcal) | 8,000 kJ (1,910 kcal) |
Osmolality | 950 mOsm/kg | 950 mOsm/kg | 950 mOsm/kg | 950 mOsm/kg |
Theoretical osmolarity | 840 mOsm/l | 840 mOsm/l | 840 mOsm/l | 840 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 peri 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 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 responsible:
- Braun Melsungen AG
Am Schwerzelshof 1
34 212 Melsungen
Germany
Further information about this medicine can be obtained by contacting the local representative of the Marketing Authorization Holder
- Braun Medical, S.A.
Ctra. de Terrassa, 121
08191 Rubí, Spain
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 Nutriflex Lipid peri B.Braun
Belgium Nutriflex Lipid peri, 32 g/l AA + 64 g/l G, emulsie voor infusie
Denmark Lipoflex peri
Finland Nutriflex Lipid 32/64/40 perifer
Germany Nutriflex Lipid 32/64 peri
Iceland Nutriflex Lipid 32/64 peri
Italy Lipoflex AA32/G64 emulsione per infusione
Luxembourg Nutriflex Lipid 32/64 peri
Netherlands Nutriflex Lipid peri, 32 g/l + 64 g/l, emulsie voor infusie
Norway Lipoflex peri
Poland Lipoflex peri
Romania Lipoflex peri emulsie perfuzabila
Spain Lipoflex peri emulsión para perfusión
Sweden Nutriflex Lipid 32/64/40 perifer
United Kingdom
(Northern Ireland) Lipoflex peri emulsion for infusion
Date of the most recent review of this leaflet:
09/2023
Detailed information on this medicine 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 visually inspected 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 in appearance. 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 if colour change of the emulsion or signs of phase separation occur.
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.
For opening: tear open 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 contents of the bag thoroughly (Fig. 5) and visually inspect the mixture for precipitates (Fig. 6). The solution should only be used if it is transparent.
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. Once all chambers have been mixed, compatible additives may be added via the medication port (Fig. 4). Mix the contents of the bag 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 strip (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 perform the infusion according to 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 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 compatible additives. Otherwise, the in-use storage times and conditions prior to use are the responsibility of the user.
The emulsion should be used immediately after opening the container.
The recommended duration for infusion of a parenteral nutrition bag is a maximum of 24 hours.
This medicine must not be mixed with other medicinal products whose compatibility has not been documented.
This medicine must not be administered simultaneously with blood through the same infusion set due to the risk of pseudoagglutination.