Infusion solution, emulsion
What Nutriflex Omega plus is and what it is used for
Nutriflex Omega plus contains fluids and substances called amino acids, electrolytes, and fatty acids that are necessary for the body’s growth or recovery. It also contains energy in the form of carbohydrates and fats.
You get Nutriflex Omega plus when you can not eat food in the usual way. There are many occasions when this can happen, e.g. when you recover from surgery, injuries, or burns, or when food cannot be absorbed from the stomach or intestines.
Nutriflex Omega plus is given to adults.
What you need to know before you use Nutriflex Omega plus
Do not use Nutriflex Omega plus
- if you are allergic to any active substance, to eggs, peanuts, soybeans or fish or to any of the other ingredients of this medicine (listed in section 6).
- This medicine should not be given to newborns, infants or children under 2 years of age.
You should also not use Nutriflex Omega plus if you have any of the following conditions:
- life-threatening circulation problems that can occur e.g. in case of unconsciousness or shock
- heart attack or stroke
- severely impaired blood coagulation ability, risk of bleeding (severe coagulopathy , pronounced hemorrhagic diathesis)
- blood or fat clots in the blood vessels (emboli)
- severe liver failure
- impaired bile flow (intrahepatic cholestasis)
- severe renal failure not treated with dialysis
- disturbances in the body’s salt balance
- dehydration or excess fluid in the body
- fluid in the lungs ( pulmonary edema )
- severe heart failure
- certain metabolic disorders, such as
- too much lipid (fat) in the blood (severe hypertriglyceridemia )
- congenital disorders of amino acid metabolism
- abnormally high blood sugar levels that require treatment with more than 6 units of insulin per hour to be under control
- abnormalities in metabolism that may occur after surgery or injury
- coma of unknown origin
- insufficient oxygen supply to the tissues
- abnormally high acid level in the blood.
Warnings and cautions
Talk to your doctor before using Nutriflex Omega plus.
Inform the doctor:
- if you have heart, liver or kidney problems
- if you have metabolic disorders such as diabetes , abnormal blood fat levels and disorders of the body’s fluid and salt balance or acid-base balance .
When you receive this medicine, you will be closely monitored to detect any early signs of an allergic reaction (eg fever, chills, rash, or shortness of breath).
Continued monitoring and testing, such as various blood tests, will be performed to ensure that your body is using the supplied nutrients properly.
Healthcare professionals will also take steps to ensure that your fluid and electrolyte needs are met. You can also get other nutritional solutions, in addition to Nutriflex Omega plus, to completely cover your nutritional needs.
Children and young people
Safety and efficacy in children and adolescents have not been established. This medicine should not be given to newborns, infants, or young children under 2 years of age.
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 may affect or be affected by certain other medicines. Tell your doctor if you take or receive any of the following:
- insulin
- heparin
- drugs that inhibit the blood’s ability to coagulate (coagulate) as warfarin or other coumarin derivatives
- drugs that increase urinary excretion ( diuretics )
- medicines for the treatment of high blood pressure ( ACE inhibitors )
- medicines to treat high blood pressure or heart problems ( angiotensin II receptor antagonists)
- drugs used in organ transplants, such as ciclosporin and tacrolimus
- drugs to treat inflammation ( corticosteroids )
- hormone preparations that affect fluid balance (adrenocorticotropic hormone ie ACTH).
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine. If you are pregnant, you will only be given this medicine if your doctor thinks it is necessary for your recovery. There are no data on the use of Nutriflex Omega plus in pregnant women.
Breast-feeding is not recommended for mothers receiving parenteral nutrition.
Driving and using machines
Nutriflex Omega plus is normally given to bedridden patients e.g. hospital or clinic and thus excludes driving and using machines. However, the drug itself does not affect the ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
How to use Nutriflex Omega plus
This medicine is given to you as an intravenous infusion (drip), ie. via a small hose directly into a friend. This medicine is given only in a larger (central) vein.
Your doctor will decide how much of this medicine you need and for how long you need to be treated.
Use for children and adolescents
This medicine should not be given to newborns, infants, or children under 2 years of age. Safety and efficacy in children and adolescents have not been established.
If you take more Nutriflex Omega plus than you should
If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you have been given too much of this medicine, it can lead to a so-called congestion syndrome and the following symptoms:
- excess fluid and electrolyte disturbances
- fluid in the lungs ( pulmonary edema )
- loss of amino acids via the urine and disturbances in the amino acid balance
- vomiting, nausea
- overindulge
- high blood sugar levels
- glucose in the urine
- dehydration
- the blood becomes much more concentrated than normal (hyperosmolality)
- decreased consciousness or unconsciousness due to extremely high blood sugar levels
- enlarged liver ( hepatomegaly ) with or without jaundice (jaundice)
- enlarged spleen ( splenomegaly )
- accumulation of fat in the internal organs
- abnormal liver function values
- decreased number of red blood cells ( anemia )
- decreased white blood cell count ( leukopenia )
- decreased platelet count ( thrombocytopenia )
- increased amount of immature red blood cells (reticulocytosis)
- decay of blood cells ( hemolysis )
- bleeding or tendency to bleed
- disturbance in the coagulation capacity of the blood (such as altered bleeding time, coagulation time, prothrombin time, etc.)
- fever
- high fat levels in the blood
- unconsciousness.
If any of these symptoms occur, the infusion should be stopped immediately.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects can be serious. If you get any of the following symptoms, tell your doctor immediately who will stop giving you this medicine.
Rare (affects 1 to 10 users in 10,000):
- allergic reactions, e.g. skin reactions, shortness of breath, swelling of the lips, mouth and throat, difficulty breathing.
Other side effects:
Uncommon (affects 1 to 10 users in 1,000):
- nausea, vomiting, loss of appetite.
Rare (affects 1 to 10 users in 10,000):
- increased blood coagulation capacity
- bluish discoloration of the skin
- shortness of breath
- headache
- heat wave
- redness ( erythema )
- sweating
- overindulge
- feel cold
- high body temperature
- drowsiness
- pain in the chest, back, skeleton or lumbar spine
- lowering or raising of blood pressure et.
Very rare (affects less than 1 user in 10,000):
- abnormally high blood fats or blood sugar levels
- high levels of acidic substances in the blood
- Excess fats can lead to fat overload syndrome, for more information see “If you have used too much Nutriflex Omega plus” in section 3. The symptoms usually disappear when the infusion is stopped.
Has been reported (occurs in an unknown number of users):
- decreased white blood cell count ( leukopenia )
- decreased platelet count ( thrombocytopenia )
- decreased bile flow (cholestasis)
How to store Nutriflex Omega plus
Keep this medicine out of the sight and reach of children.
Do not store above 25 ° C. Store the bags in the outer carton. Sensitive to light.
Do not freeze. If the packaging is accidentally frozen, it must be discarded.
Do not use this medicine after the expiry date which is stated on the label.
Contents of the pack and other information
Content declaration
The active substances in the ready-to-use mixture are:
| From the upper left ventricle (glucose solution) | and 1000 ml | and 1250 ml | in 1875 ml | and 2500 ml |
| Glucose monohydrate | 132.0 g | 165.0 g | 247.5 g | 330.0 g |
| corresponding 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 upper right chamber (fat emulsion) | and 1000 ml | and 1250 ml | in 1875 ml | and 2500 ml |
| Medium chain triglycerides | 20.00 g | 25.00 g | 37.50 g | 50.00 g |
| Soybean oil, refined | 16.00 g | 20.00 g | 30.00 g | 40.00 g |
| Omega-3 acid triglycerides | 4,000 g | 5,000 g | 7,500 g | 10.00 g |
| From the lower chamber (amino acid solution) | and 1000 ml | and 1250 ml | in 1875 ml | and 2500 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 | 2,728 g | 3,410 g | 5.115 g | 6,820 g |
| corresponding to lysine | 2,184 g | 2,729 g | 4,094 g | 5.459 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 |
| Troponin | 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 |
| Valin | 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 |
| Histidine hydrochloride monohydrate | 1.624 g | 2,030 g | 3,045 g | 4,060 g |
| corresponding to histidine | 1,202 g | 1,503 g | 2,254 g | 3,005 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 |
| Protein | 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 |
| and 1000 ml | and 1250 ml | in 1875 ml | and 2500 ml | |
| Amino acid content [g] | 38 | 48 | 72 | 96 |
| Nitrogen content [g] | 5.4 | 6.8 | 10.2 | 13.6 |
| Carbohydrate content [g] | 120 | 150 | 225 | 300 |
| Lipid content [g] | 40 | 50 | 75 | 100 |
| Electrolytes [ mmol] | and 1000 ml | and 1250 ml | in 1875 ml | and 2500 ml |
| Sodium | 40 | 50 | 75 | 100 |
| Potassium | 28 | 35 | 52.5 | 70 |
| Magnesium | 3.2 | 4.0 | 6.0 | 8.0 |
| Calcium | 3.2 | 4.0 | 6.0 | 8.0 |
| Zinc | 0.024 | 0.03 | 0.045 | 0.06 |
| Chloride | 36 | 45 | 67.5 | 90 |
| Acetate | 36 | 45 | 67.5 | 90 |
| Phosphate | 12 | 15 | 22.5 | 30 |
| and 1000 ml | and 1250 ml | in 1875 ml | and 2500 ml | |
| Lipid energy [kJ (kcal)] | 1590 (380) | 1990 (475) | 2985 (715) | 3980 (950) |
| Carbohydrate energy [kJ (kcal)] | 2010 (480) | 2510 (600) | 3765 (900) | 5020 (1200) |
| Amino acid energy [kJ (kcal)] | 635 (150) | 800 (190) | 1200 (285) | 1600 (380) |
| Non-protein energy [kJ (kcal)] | 3600 (860) | 4500 (1075) | 6750 (1615) | 9000 (2155) |
| Total energy [kJ (kcal)] | 4235 (1010) | 5300 (1265) | 7950 (1900) | 10600 (2530) |
| Osmolality [mOsm / kg] | 1540 |
| Theoretical osmolarity [mOsm / l] | 1215 |
| pH | 5.0–6.0 |
The other ingredients are citric acid monohydrate (for pH adjustment), glycerol, egg lecithin, sodium oleate, sodium hydroxide (for pH adjustment), all -rac -α-tocopherol, and water for injections.
What the medicine looks like and contents of the pack
The reconstituted drug is an emulsion for infusion, ie. given through a small tube into a vein.
Nutriflex Omega plus is delivered in flexible multi-chamber bags that contain:
– 1250 ml (500 ml amino acid solution + 250 ml fat emulsion + 500 ml glucose solution)
– 1875 ml (750 ml amino acid solution + 375 ml fat emulsion + 750 ml glucose solution)
– 2500 ml (1000 ml amino acid solution + 500 ml fat emulsion + 1000 ml glucose solution)
The glucose and amino acid solutions are clear and colorless to straw-colored.
The fat emulsion is milky white.
The multi-chamber bag is packed in a protective package. Between the bag and the protective packaging, there is an oxygen absorber and an oxygen indicator.
The oxygen absorber bag consists of inert material and contains iron hydroxide.
The two upper chambers can be combined with the lower chamber by breaking the intermediate seal.
The different pack sizes are delivered in cartons with five bags.
Pack sizes: 5×1250 ml, 5×1875 ml and 5×2500 ml.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer:
| B. Braun Melsungen AGCarl-Braun-Strasse 1,34212 Melsungen, Germany | Postal address:34209 Melsungen, Germany |
Further information on this medicine can be obtained from the representative of the marketing authorization holder:
B. Braun Medical AB
Box 110
182 12 Danderyd