Nutriflex Omega Plus Emulsion For Infusion
170/12609620/0815
Package leaflet: Information for the user
M Nutriflex® Omega plus
emulsion for infusion
Approval for Printing
BlBRAUN Melsungen AG
Approved for Printing
Approved for Printing when corrected
New draft required
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Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• 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.
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Date |
Signature |
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Name in capital letters |
schwarz
What is in this leaflet
1. What Nutriflex® Omega plus is and what it is used for
2. What you need to know before you use Nutriflex® Omega plus
3. How to use Nutriflex® Omega plus
4. Possible side effects
5. How to store Nutriflex® Omega plus
6. Contents of the pack and other information
1. What Nutriflex® Omega plus is and what it is used for
Nutriflex® Omega plus contains 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 Nutriflex® Omega plus 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 Nutriflex® Omega plus
Do not use Nutriflex® Omega plus
• if you are allergic to egg, peanut, soybean or fish or 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 Nutriflex® Omega plus 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)
• blocking of blood vessels by blood clots or fat (embolism)
• severe liver failure
• impaired bile flow (intrahepatic cholestasis)
• severe kidney failure where no dialysis facilities are available
• 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
- too much lipid (fat) in the blood
- inborn errors of amino acid metabolism
- abnormally high blood sugar level that needs more than 6 units of insulin per hour to be controlled
- abnormalities of metabolism that may occur after operations or injuries
- coma of unknown origin
- insufficient supply of oxygen to tissues
- abnormally high acid level in the blood.
Warnings and precautions
Talk to your doctor before using Nutriflex® Omega plus.
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
• your blood clotting function is impaired or if your vitamin K level might be too low.
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 Nutriflex® Omega plus you may receive further nutrients (foodstuffs) in order to fully cover your requirements.
Children and adolescents
Safety and efficacy in children and adolescents have not been established. This medicine must not be given to newborn infants, infants and toddlers under two years old.
Other medicines and Nutriflex® Omega plus
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Nutriflex® Omega plus 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 or heart problems (ACE-inhibitors and angiotensin-II-receptor antagonists)
• medicines used in organ transplants such as cyclosporin and tacrolimus
• medicines to treat inflammation (corticosteroids)
• hormone preparations that affect your fluid balance (adrenocorticotropic hormone [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 Nutriflex® Omega plus in pregnant women.
Breast-feeding is not recommended for mothers on parenteral nutrition.
Driving and using machines
Nutriflex® Omega plus is normally given to immobile patients in a hospital or clinic. This will exclude driving and using machines.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you use more Nutriflex® Omega plus 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 (leukopenia)
• 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.
Latus 1398
Format = 210 x 594 mm 2 Seiten
GB-IE_170
Nutriflex® Omega plus 170/12609620/0815 GIF - 3KB
Standort Melsungen
Font size: 9,5 pt.
G 121712
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 (affects 1 to 10 users in 10,000):
• allergic reactions, for example skin reactions, shortness of breath, swelling of the lips, mouth and throat, difficulty breathing.
Other side effects include:
Uncommon (affects 1 to 10 users in 1,000):
• 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 (affects less than 1 user in 10,000):
• 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 Nutriflex® Omega plus than you should" in section 3. Symptoms normally disappear when the infusion is stopped.
Reporting of side effects:
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly via the:
United Kingdom: Yellow Card Scheme at www.mhra.gov.uk/yellowcard. Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; e-mail: medsafety@hpra.ie
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Nutriflex® Omega plus
Keep this medicine out of the sight and reach of children.
Do not store above 25 °C. Keep the bags in the outer carton in order to protect from light.
Do not freeze. If accidentally frozen, discard the bag.
Do not use this medicine after the expiry date which is stated on the label.
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from the upper, left-hand chamber (glucose solution) |
in 1000 ml |
in 1250 ml |
in 1875 ml |
in 2500 ml |
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Glucose monohydrate equivalent to anhydrous 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 |
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Sodium dihydrogen phosphate dihydrate |
1.872 g |
2.340 g |
3.510 g |
4.680 g |
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Zinc acetate dihydrate |
5.264 mg |
6.580 mg |
9.870 mg |
13.16 mg |
3. How to use Nutriflex® Omega plus
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 and adolescents
Safety and efficacy in children and adolescents have not been established. This medicine must not be given to newborn infants, infants and toddlers under two years old.
12609620_NutriflexOmega plus_GIF-3KB_210x594__GB-IE_170.indd 1
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from the upper, right-hand chamber (fat emulsion) |
in 1000 ml |
in 1250 ml |
in 1875 ml |
in 2500 ml |
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Medium-chain triglycerides |
20.00 g |
25.00 g |
37.50 g |
50.00 g |
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Soya-bean oil refined |
16.00 g |
20.00 g |
30.00 g |
40.00 g |
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Omega-3-acid triglycerides |
4.000 g |
5.000 g |
7.500 g |
10.00 g |
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from the lower chamber (amino acid solution) |
in 1000 ml |
in 1250 ml |
in 1875 ml |
in 2500 ml |
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Isoleucine |
2.256 g |
2.820 g |
4.230 g |
5.640 g |
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Leucine |
3.008 g |
3.760 g |
5.640 g |
7.520 g |
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Lysine hydrochloride |
2.728 g |
3.410 g |
5.115 g |
6.820 g |
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equivalent to lysine |
2.184 g |
2.729 g |
4.094 g |
5.459 g |
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Methionine |
1.880 g |
2.350 g |
3.525 g |
4.700 g |
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Phenylalanine |
3.368 g |
4.210 g |
6.315 g |
8.420 g |
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Threonine |
1.744 g |
2.180 g |
3.270 g |
4.360 g |
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Tryptophan |
0.544 g |
0.680 g |
1.020 g |
1.360 g |
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Valine |
2.496 g |
3.120 g |
4.680 g |
6.240 g |
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Arginine |
2.592 g |
3.240 g |
4.860 g |
6.480 g |
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Histidine hydrochloride monohydrate |
1.624 g |
2.030 g |
3.045 g |
4.060 g |
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equivalent to histidine |
1.202 g |
1.503 g |
2.254 g |
3.005 g |
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Alanine |
4.656 g |
5.820 g |
8.730 g |
11.64 g |
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Aspartic acid |
1.440 g |
1.800 g |
2.700 g |
3.600 g |
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Glutamic acid |
3.368 g |
4.210 g |
6.315 g |
8.420 g |
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Glycine |
1.584 g |
1.980 g |
2.970 g |
3.960 g |
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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 |
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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 |
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Magnesium acetate tetrahydrate |
0.686 g |
0.858 g |
1.287 g |
1.716 g |
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Calcium chloride dihydrate |
0.470 g |
0.588 g |
0.882 g |
1.176 g |
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Electrolytes |
in 1000 ml |
in 1250 ml |
in 1875 ml |
in 2500 ml |
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Sodium |
40 mmol |
50 mmol |
75 mmol |
100 mmol |
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Potassium |
28 mmol |
35 mmol |
52.5 mmol |
70 mmol |
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Magnesium |
3.2 mmol |
4.0 mmol |
6.0 mmol |
8.0 mmol |
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Calcium |
3.2 mmol |
4.0 mmol |
6.0 mmol |
8.0 mmol |
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Zinc |
0.024 mmol |
0.03 mmol |
0.045 mmol |
0.06 mmol |
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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 |
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Amino acid content |
38 g |
48 g |
72 g |
96 g |
|
Nitrogen content |
5.4 g |
6.8 g |
10.2 g |
13.6 g |
|
Carbohydrate content |
120 g |
150 g |
225 g |
300 g |
|
Lipid content |
40 g |
50 g |
75 g |
100 g |
What Nutriflex® Omega 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.
Nutriflex® Omega plus is supplied in flexible multichamber bags containing:
• 1250 ml (500 ml of amino acids solution + 250 ml of fat emulsion + 500 ml of glucose solution)
• 1875 ml (750 ml of amino acids solution + 375 ml of fat emulsion + 750 ml of glucose solution)
• 2500 ml (1000 ml of amino acids solution + 500 ml of fat emulsion + 1000 ml of glucose solution)
The glucose and the amino acid solutions are clear and colourless up to straw-coloured. The fat emulsion is milky-white.
The multichamber bag is packed in a protective overwrap. An oxygen absorber is placed between the bag and the overwrap.
The two upper chambers can be connected with the lower chamber by opening the intermediate seam.
The different container sizes are presented in cartons 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-StraBe 1 Postal address:
34212 Melsungen, Germany 34209 Melsungen, Germany
Phone: +49-5661-71-0 Fax: +49-5661-71-4567
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria NuTRIflex Omega plus
Belgium NuTRIflex Omega plus
Bulgaria NuTRIflex Omega plus
Cyprus NuTRIflex Omega plus
Czech Republic NuTRIflex Omega plus
Denmark Nutriflex Omega plus
Estonia NuTRIflex Omega
Finland Nutriflex Omega plus
France Mednutriflex Omega G 120/N 5,4/E
Germany NuTRIflex Omega plus
Greece NuTRIflex Omega plus
Hungary NuTRIflex Omega plus
Ireland Nutriflex® Omega plus
Italy Nutriplus Omega
Latvia NuTRIflex Omega
Lithuania NuTRIflex Omega
Luxembourg NuTRIflex Omega plus
Netherlands NuTRIflex Omega plus
Norway Nutriflex Omega plus
Poland NuTRIflex Omega plus
Portugal NuTRIflex Omega P
Romania NuTRIflex Omega plus
Slovakia NuTRIflex Omega plus
Slovenia Nutriflex Omega G 120/N5,4/E
Spain NuTRIflex Omega plus
Sweden Nutriflex Omega plus
United Kingdom Nutriflex® Omega plus
This leaflet was last revised in July 2015
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Energy in the form of lipid |
1590 kJ (380 kcal) |
1990 kJ (475 kcal) |
2985 kJ (715 kcal) |
3980 kJ (950 kcal) |
|
Energy in the form of carbohydrates |
2010 kJ (480 kcal) |
2510 kJ (600 kcal) |
3765 kJ (900 kcal) |
5020 kJ (1200 kcal) |
|
Energy in the form of amino acids |
635 kJ (150 kcal) |
800 kJ (190 kcal) |
1200 kJ (285 kcal) |
1600 kJ (380 kcal) |
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Non-protein energy |
3600 kJ (860 kcal) |
4500 kJ (1075 kcal) |
6750 kJ (1615 kcal) |
9000 kJ (2155 kcal) |
|
Total energy |
4235 kJ (1010 kcal) |
5300 kJ (1265 kcal) |
7950 kJ (1900 kcal) |
10600 kJ (2530 kcal) |
Nutriflex® Omega plus is supplied in containers for single use. Discard container and any unused content after use.
Do not re-connect partially used containers.
Only use bags that are undamaged and in which the amino acid and glucose solutions are clear, colourless up to straw-coloured solutions. Do not use bags where there is a discolouration or discernible phase separation (oil drops) in the chamber containing the lipid emulsion.
If filters are used they must be lipid-permeable.
|
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 |
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pH |
5.0 - 6.0 |
5.0 - 6.0 |
5.0 - 6.0 |
5.0 - 6.0 |
The other ingredients are citric acid monohydrate, egg lecithin, glycerol, sodium oleate, all-rac-a-tocopherol, sodium hydroxide for pH adjustment and water for injections.
Preparation of the mixed emulsion:
Remove inner bag from its protective overwrap and proceed as follows:
• put the bag on a solid, flat surface
• mix glucose with amino acids by pressing the upper left chamber against the peel seam, then add the fat emulsion by pressing the upper right chamber against the peel seam
• mix the contents of the bag thoroughly.
Preparation for infusion:
• fold the bag and hang it on the infusion stand by the centre hanging loop
• remove the protective cap from the infusion port and carry out infusion using the standard technique.
The mixture is a milky white homogenous oil-in-water emulsion.
The emulsion should always be brought to room temperature prior to infusion.
Shelf life after removing the protective overwrap and after mixing of the contents of the bag:
Chemical and physical in-use stability after mixing the contents has been demonstrated for 7 days at 2 - 8 °C. After removing this bag from the refrigerator it is stable for 48 hours at 25 °C.
Shelf life after admixture of compatible additives:
From a microbiological point of view, the product should be used immediately after admixture of additives. If not used immediately after admixture of additives, in-use storage times and conditions prior to use are the responsibility of the user.
The emulsion is to be used immediately after opening of the container. Nutriflex Omega plus may only be mixed with other medicinal products for which compatibility has been documented. Compatibility data for different additives (e.g. electrolytes, trace elements, vitamins) and the corresponding shelf life of such admixtures can be provided on demand by the manufacturer.
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