Patient leaflet - LIPOFLEX SPECIAL EMULSION FOR INFUSION
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
if you get any side effects, talk to your doctor, pharmacist or nurse. this includes any possible side effects not listed in this leaflet. see section 4.
What is in this leaflet
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1. What Lipoflex special is and what it is used for
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2. What you need to know before you use Lipoflex special
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3. How to use Lipoflex special
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4. Possible side effects
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5. How to store Lipoflex special
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6. 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 the body to grow or to recover. It also contains calories in the form of carbohydrates and fats.
You are given Lipoflex special when you are unable to eat food normally. There are many situations when this might be the case, for example when you are recovering from surgery, injuries or burns, or when you are unable to absorb food from your stomach and gut.
2. what you need to know before you use lipoflex special if you are allergic to any of the active substances, to egg, peanut or soybean or to any of the other ingredients of this medicine (listed in section 6).
- This medicine must not be given to newborn infants, infants and toddlers under two years old.
Also, do not use Lipoflex special if you suffer from any of the following:
- life-threatening blood circulation problems such as those that can occur if you are in a state of collapse or shock
- heart attack or stroke
- severely impaired blood clotting function, bleeding risk (severe coagulopathy, aggravating haemorrhagic diatheses)
- blocking of blood vessels by blood clots or fat (embolism)
- severe liver failure
- impaired bile flow (intrahepatic cholestasis)
- severe kidney failure in the absence of kidney replacement therapy
- disturbances of your body salt composition
- fluid deficit or excess water in your body
- water on your lungs (pulmonary oedema)
- severe heart failure
- certain metabolic disorders such as
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– too much lipid (fat) in the blood
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– inborn errors of amino acid metabolism
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– abnormally high blood sugar level that needs more than 6 units of insulin per hour to be controlled
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– abnormalities of metabolism that may occur after operations or injuries
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– coma of unknown origin
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– insufficient supply of oxygen to tissues
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– abnormally high acid level in the blood.
Warnings and precautions
Talk to your doctor before using Lipoflex special.
Please inform your doctor if:
- you have heart, liver or kidney problems
- you suffer from certain types of metabolic disorders such as diabetes, abnormal blood fat values and
disorders of your body fluid and salt composition or your acid-base balance.
You will be monitored closely to detect early signs of an allergic reaction (such as fever, shivering, rash, or shortness of breath) when you receive this medicine.
Further monitoring and tests such as various examinations of blood samples will be applied to make sure that your body handles the administered foodstuffs properly.
The nursing staff may also take measures to ensure that your body’s fluid and electrolyte requirements are met. In addition to Lipoflex special you may receive further nutrients (foodstuffs) in order to fully cover your requirements.
Children
This medicine must not be given to newborn infants, infants and toddlers under two years old.
Other medicines and Lipoflex special
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Lipoflex special can interact with some other medicines. Please tell your doctor if you are taking or receiving any of the following:
- insulin
- heparin
- medicines that prevent undesirable blood clotting such as warfarin or other coumarin derivatives
- medicines to promote urine flow (diuretics)
- medicines to treat high blood pressure (ACE inhibitors)
- medicines to treat high blood pressure or heart problems (angiotensin-II-receptor antagonists)
- medicines used in organ transplants such as ciclosporin and tacrolimus
- medicines to treat inflammation (corticosteroids)
- hormone preparations that affect your fluid balance (adrenocorticotropic hormone or ACTH)
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. If you are pregnant, you will receive this medicine only if the doctor considers it absolutely necessary for your recovery. There is no data available about the use of Lipoflex special in pregnant women.
Breast-feeding is not recommended for mothers on parenteral nutrition.
Driving and using machines
This medicine is normally given to immobile patients, e.g. in a hospital or clinic which would exclude driving or using machines. However, the medicine itself has no effect on the ability to drive or use machines.If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
3. how to use lipoflex special
This medicine is administered by intravenous infusion (drip), that is, through a small tube directly into a vein.
This medicine will be administered through one of your large (central) veins only.
Your doctor will decide how much of this medicine you need and for how long you will require treatment with this medicine.
Use in children
This medicine must not be given to newborn infants, infants and toddlers under two years old.
If you use more Lipoflex special than you should
If you have received too much of this medicine you may suffer from a so-called ‘overload syndrome’ and the following symptoms:
- fluid excess and electrolyte disorders
- water on your lungs (pulmonary oedema)
- loss of amino acids through the urine and disturbed amino acid balance
- vomiting, feeling sick
- shivering
- high blood sugar level
- glucose in the urine
- fluid deficit
- blood much more concentrated than normal (hyperosmolality)
- impairment or loss of consciousness due to extremely high blood sugar
- enlargement of the liver (hepatomegaly) with and without jaundice (icterus)
- enlargement of the spleen (splenomegaly)
- fat deposition in the inner organs
- abnormal values of liver function tests
- reduction of red blood cell count (anaemia)
- reduction of white blood cell count (leucopenia)
- reduction of blood platelet count (thrombocytopenia)
- increase of immature red blood cells (reticulocytosis)
- rupture of blood cells (haemolysis)
- bleeding or a tendency to bleeding
- impairment of blood coagulation (as can be seen by changes of bleeding time, coagulation time, prothrombin time etc.)
- fever
- high blood fat levels
- loss of consciousness
If any of these symptoms occur, the infusion must be stopped immediately.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may be serious. If any of the following side effects occur, tell your doctor immediately, he will stop giving you this medicine:
Rare (may affect up to 1 in 1,000 people):
- allergic reactions, for example skin reactions, shortness of breath, swelling of the lips, mouth, and throat, difficulty breathing
Other side effects include:
Uncommon (may affect up to 1 in 100 people):
- feeling sick, vomiting, loss of appetite
Rare (affects 1 to 10 users in 10,000):
- increased tendency for your blood to clot
- bluish discolouration of the skin
- shortness of breath
- headache
- flushing
- reddening of skin (erythema)
- sweating
- chills
- feeling cold
- high body temperature
- drowsiness
- pain in the chest, back, bones or lumbar region
- decrease or increase in blood pressure
Very rare (may affect up to 1 in 10,000 people):
- abnormally high blood fat or blood sugar values
- high levels of acidic substances in your blood
- Too much lipid can lead to fat overload syndrome, for more information on this please see under the heading “If you use more Lipoflex 56/144 special than you should” in section 3. Symptoms normally disappear when the infusion is stopped.
Not known (frequency cannot be estimated from the available data):
- reduction of white blood cell count (leucopenia)
- reduction of blood platelet count (thrombocytopenia)
- impaired bile flow (cholestasis)
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at:.. By reporting side effects you can help provide more information on the safety of this medicine.
5. how to store lipoflex special
Keep this medicine out of the sight and reach of children.
Do not store above 25 °C.
Do not freeze. If accidentally frozen, discard the bag.
Keep the bag in the protective overwrap in order to protect from light.
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
6. contents of the pack and other information
The active substances in the ready-for-use mixture are:
| from the top chamber (glucose solution) | in 1000 ml | in 625 ml | in 1250 ml | in 1875 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 1000 ml | in 625 ml | in 1250 ml | in 1875 ml |
| Soya-bean oil, refined | 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 bottom chamber (amino acid solution) | in 1000 ml | in 625 ml | in 1250 ml | in 1875 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 3.186g | 2.488 g 1.991 g | 4.975 g 3.982 g | 7.463 g 5.973 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 |
| Histidine hydrochloride | 2.368 g | 1.480 g | 2.960 g | 4.440 g |
| monohydrate equivalent to histidine | 1.753 g | 1.095 g | 2.191 g | 3.286 g |
| Alanine | 6.792 g | 4.245 g | 8.490 g | 12.73 g |
| Aspartic acid | 2.100g | 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 1000 ml | in 625 ml | in 1250 ml | in 1875 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 in the form of lipids | 1590 kJ (380 kcal) | 995 kJ (240 kcal) | 1990 kJ (475 kcal) | 2985 kJ (715 kcal) |
| Energy in the form of carbohydrates | 2415 kJ (575 kcal) | 1510 kJ (360 kcal) | 3015 kJ (720 kcal) | 4520 kJ (1080 kcal) |
| Energy in the form of amino acids | 940 kJ (225 kcal) | 585 kJ (140 kcal) | 1170 kJ (280 kcal) | 1755 kJ (420 kcal) |
| Non-protein energy | 4005 kJ (955 kcal) | 2505 kJ (600 kcal) | 5005 kJ (1195 kcal) | 7505 kJ (1795 kcal) |
| Total energy | 4945 kJ (1180 kcal) | 3090 kJ (740 kcal) | 6175 kJ (1475 kcal) | 9260 kJ (2215 kcal) |
| Osmolality | 2115 mOsm/kg | 2115 mOsm/kg | 2115 mOsm/kg | 2115 mOsm/kg |
| Theoretical osmolarity | 1545 mOsm/l | 1545 mOsm/l | 1545 mOsm/l | 1545 mOsm/l |
| pH | 5.0 – 6.0 | 5.0 – 6.0 | 5.0 – 6.0 | 5.0 – 6.0 |
The other ingredients are citric acid monohydrate (for pH adjustment), egg lecithin, glycerol, sodium oleate, all-rac-alpha-tocopherol and water for injections.
What Lipoflex special 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 special is supplied in flexible multichamber bags containing:
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– 625 ml (250 ml of amino acids solution + 125 ml of fat emulsion + 250 ml of glucose solution)
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– 1250 ml (500 ml of amino acids solution + 250 ml of fat emulsion + 500 ml of glucose solution)
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– 1875 ml (750 ml of amino acids solution + 375 ml of fat emulsion + 750 ml of glucose solution)
Figure A
Figure B
Figure A: The multichamber bag is packed in a protective overwrap. An oxygen absorber and an oxygen indicator are placed between the bag and the overwrap; the oxygen absorber sachet is made of inert material and contains iron hydroxide.
Figure B: The top chamber contains a glucose solution, the middle chamber contains a fat emulsion, and the bottom chamber contains an amino acid solution.
The glucose and the amino acid solutions are clear and colourless or straw-coloured. The fat emulsion is milky-white.
The top chamber and the middle chamber can be connected with the bottom chamber by opening the intermediate seams.
The different container sizes are presented in cartons containing five bags.
Pack sizes: 5 × 625 ml, 5 × 1250 ml and 5 × 1875 ml
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
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B. Braun Melsungen AG