infusion solution, emulsion
What Nutriflex Omega 38/120/40 is and what it is used for
Nutriflex Omega 38/120/40 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.
Nutriflex Omega 38/120/40 is given to adults.
You get Nutriflex Omega 38/120/40 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.
What you need to know before you get Nutriflex Omega 38/120/40
Do not use Nutriflex Omega 38/120/40
- if you are allergic to the active substances, 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 38/12/40 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 disturbances in metabolism such as- too much lipid (fat) in the bloodcongenital disorders of amino acid metabolism- abnormally high blood sugar level requiring treatment with more than 6 units of insulin per hour to be under controlabnormalities in metabolism that may occur after surgery or injurycoma of unknown origininsufficient supply of oxygen to the tissues- abnormally high acid level in the blood.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Nutriflex Omega 38/120/40. 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 will also receive other nutritional solutions, in addition to Nutriflex Omega 38/120/40, to fully cover your nutritional needs.
Children
Safety and efficacy in children over 2 years of age have not yet been established. No data is available.
This medicine should not be given to newborns, infants, or children under 2 years of age.
Other medicines and Nutriflex Omega 38/120/40
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Nutriflex Omega 38/120/40 may affect or be affected by certain other medicines. Tell your doctor, pharmacist, or nurse if you are taking or receiving 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 to treat high blood pressure or heart problems ( ACE inhibitors and angiotensin II receptor antagonists)
- drugs used in organ transplants such as ciclosporin and tacrolimus
- drugs to treat inflammation (cortisone preparations)
- 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 or pharmacist for advice before taking 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 38/120/40 in pregnant women.
Breast-feeding is not recommended for mothers receiving parenteral nutrition.
Driving and using machines
This drug is normally given to bedridden patients e.g. in a hospital or clinic, thus excluding 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.
Nutriflex Omega 38/120/40 contains sodium
This medicine contains 1150 mg of sodium (the main ingredient in table salt/table salt) per 1250 ml bag. This corresponds to 58% of the maximum recommended daily sodium intake for adults.
Consult a doctor or pharmacist if your need is one or more bags daily for an extended time, especially if you have been prescribed a low-salt (sodium-poor) diet.
3. How to use Nutriflex Omega 38/120/40
This medicine is given to you as an intravenous infusion (drip), ie. via a small tube directly into a vein, it is given only in a larger (central) vein.
The recommended infusion time for a parenteral nutrition bag is a maximum of 24 hours.
Your doctor will decide how much of this medicine you need and for how long you need to be treated.
Use for children
Safety and efficacy in children over 2 years of age have not yet been established. No data is available.
This medicine should not be given to newborns, infants, or children under 2 years of age.
If you use more Nutriflex Omega 38/120/40 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.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
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 if you stop taking this medicine:
Rare (may affect up to 1 in 1,000 people):
- allergic reactions, e.g. skin reactions, shortness of breath, swelling of the lips, mouth and throat, difficulty breathing.
Other side effects:
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 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 (may affect up to 1 in 10,000 people):
- 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 38/120/40” 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 38/120/40
Keep this medicine out of the sight and reach of children.
Do not store above 25 ° C.
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 after EXP. The expiration date is the last day of the specified month.
Store the bag in the protective packaging. Sensitive to light.
Contents of the pack and other information
Content declaration
The active substances in the ready-to-use mixture are:
| from the upper chamber (glucose solution) | and 1,000 ml | and 1,250 ml | and 1,875 ml | and 2,500 ml |
| Glucose monohydratecorresponding to glucose | 132.0 g120.0 g | 165.0 g150.0 g | 247.5 g225.0 g | 330.0 g300.0 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 middle chamber (fat emulsion) | and 1,000 ml | and 1,250 ml | and 1,875 ml | and 2,500 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 1,000 ml | and 1,250 ml | and 1,875 ml | and 2,500 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 hydrochloridecorresponding to lysine | 2,728 g2,184 g | 3,410 g2,729 g | 5.115 g4,094 g | 6,820 g5.459 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 monohydratecorresponding to histidine | 1.624 g1,202 g | 2,030 g1,503 g | 3,045 g2,254 g | 4,060 g3,005 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 | 0.544 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 1,000 ml | and 1,250 ml | and 1,875 ml | and 2,500 ml | |
| Amino acid content [g] | 38 | 48 | 72 | 96 |
| Nitrogen content [g] | 5.4 | 6.8 | 10.2 | 13.7 |
| Carbohydrate content [g] | 120 | 150 | 225 | 300 |
| Lipid content [g] | 40 | 50 | 75 | 100 |
| An electrolyte is [mmol] | and 1,000 ml | and 1,250 ml | and 1,875 ml | and 2,500 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 1,000 ml | and 1,250 ml | and 1,875 ml | and 2,500 ml | |
| Lipid energy [kJ (kcal)] | 1,590 (380) | 1 990 (475) | 2 985 (715) | 3 980 (950) |
| Carbohydrate energy [kJ (kcal)] | 2 010 (480) | 2,510 (600) | 3 765 (900) | 5,020 (1,200) |
| Amino acid energy [kJ (kcal)] | 635 (150) | 800 (190) | 1,200 (285) | 1,600 (380) |
| Non-protein energy [kJ (kcal)] | 3 600 (860) | 4,500 (1,075) | 6 750 (1 615) | 9,000 (2,155) |
| Energy, total [kJ (kcal)] | 4 235 (1,010) | 5,300 (1,265) | 7,950 (1,900) | 10 600(2 530) |
| Osmolality [mOsm / kg] | 1 540 |
| Theoretical osmolarity [mOsm / l] | 1 215 |
| pH | 5.0-6.0 |
The other ingredients are citric acid monohydrate (for pH adjustment), egg phospholipids for injection, glycerol , sodium oleate, all ‑ rac ‑ α ‑ tocopherol, sodium hydroxide (for pH adjustment), 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 38/120/40 is delivered in flexible multi-chamber bags that contain:
- 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: 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.
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 colorless to straw-colored. The fat emulsion is milky white.
The upper chamber and the middle chamber can be connected to the lower chamber by opening the seals.
The different pack sizes are delivered in cartons with five bags.
Pack sizes: 5 x 1,250 ml, 5 x 1,875 ml and 5 x 2,500 ml
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
B. Braun Melsungen AG
34209 Melsungen, Germany
Information provided by:
B. Braun Medical AB
Box 110
182 12 Danderyd