Nutriflex Omega special – Amino acids, Fatty acids uses, dose and side effects

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infusion solution, emulsion

What Nutriflex Omega special is and what it is used for

Nutriflex Omega special 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 special 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 special is given to adults.

What you need to know before using Nutriflex Omega special

Do not use Nutriflex Omega special

  • 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 special 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 special.

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 special, 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 special

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

Nutriflex Omega special 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 considers it necessary for your recovery. There are no data on the use of Nutriflex Omega special in pregnant women.

Breast-feeding is not recommended for mothers receiving parenteral nutrition.

Driving and using machines

Nutriflex Omega special 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 special

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 special 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 special” in section 3. Symptoms usually disappear when an 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 special

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 mland 625 mland 1250 mlin 1875 mland 2500 ml
Glucose monohydrate158.4 g99.00 g198.0 g297.0 g396.0 g
corresponding to glucose144.0 g90.00 g180.0 g270.0 g360.0 g
Sodium dihydrogen phosphate dihydrate2,496 g1,560 g3.120 g4,680 g6,240 g
Zinc acetate dihydrate7.024 mg4,390 mg8,780 mg13.17 mg17.56 mg
From the upper right chamber (fat emulsion)and 1000 mland 625 mland 1250 mlin 1875 mland 2500 ml
Medium chain triglycerides20.00 g12.50 g25.00 g37.50 g50.00 g
Soybean oil, refined16.00 g10.00 g20.00 g30.00 g40.00 g
Omega-3 acid triglycerides4,000 g2,500 g5,000 g7,500 g10.00 g
From the lower chamber
(amino acid solution)
and 1000 mland 625 mland 1250 mlin 1875 mland 2500 ml
Isoleucine3,284 g2,053 g4.105 g6.158 g8,210 g
Leucine4.384 g2,740 g5,480 g8,220 g10.96 g
Lysine hydrochloride3,980 g2,488 g4,975 g7.463 g9,950 g
corresponding to lysine3,186 g1.991 g3,982 g5,973 g7.962 g
Methionine2,736 g1.710 g3,420 g5,130 g6,840 g
Phenylalanine4,916 g3,073 g6.145 g9,218 g12.29 g
Troponin2,540 g1,588 g3.175 g4,763 g6,350 g
Tryptophan0.800 g0.500 g1,000 g1,500 g2,000 g
Valin3,604 g2,253 g4.505 g6.758 g9,010 g
Arginine3,780 g2,363 g4,725 g7,088 g9,450 g
Histidine hydrochloride monohydrate2,368 g1,480 g2,960 g4,440 g5,920 g
corresponding to histidine1,753 g1,095 g2,191 g3,286 g4.381 g
Alanine6,792 g4.245 g8,490 g12.73 g16.98 g
Aspartic acid2,100 g1,313 g2,625 g3,938 g5,250 g
Glutamic acid4.908 g3,068 g6.135 g9,203 g12.27 g
Glycine2.312 g1.445 g2,890 g4,335 g5,780 g
Protein4,760 g2,975 g5,950 g8,925 g11.90 g
Serine4,200 g2,625 g5,250 g7.875 g10.50 g
Sodium hydroxide1.171 g0.732 g1,464 g2,196 g2,928 g
Sodium chloride0.378 g0.237 g0.473 g0.710 g0.946 g
Sodium acetate trihydrate0.250 g0.157 g0.313 g0.470 g0.626 g
Potassium acetate3,689 g2,306 g4,611 g6,917 g9,222 g
Magnesium acetate tetrahydrate0.910 g0.569 g1,137 g1,706 g2,274 g
Calcium chloride dihydrate0.623 g0.390 g0.779 g1,169 g1,558 g
and 1000 mland 625 mland 1250 mlin 1875 mland 2500 ml
Amino acid content [g]56.035.170.1105.1140.1
Nitrogen content [g]85101520
Carbohydrate content [g]14490180270360
Lipid content [g]40255075100
Electrolytes [mmol]and 1000 mland 625 mland 1250 mlin 1875 mland 2500 ml
Sodium53.633.5 67100.5134
Potassium37.623.5 4770.594
Magnesium4.22.65 5.37.9510.6
Calcium4.22.65 5.37.9510.6
Zinc0.030.020.040.060.08
Chloride48306090120
Acetate48306090120
Phosphate1610203040
and 1000 mland 625 mland 1250 mlin 1875 mland 2500 ml
Lipid energy [kJ (kcal)]1590 (380)995 (240)1990 (475)2985 (715)3980 (950)
Carbohydrate energy [kJ (kcal)]2415 (575)1510 (360)3015 (720)4520 (1080)6030 (1440)
Amino acid energy [kJ (kcal)]940 (225)585 (140)1170 (280)1755 (420)2340 (560)
Non-protein energy [kJ (kcal)]4005 (955)2505 (600)5005 (1195)7510 (1795)10010 (2390)
Total energy [kJ (kcal)]4945 (1180)3090 (740)6175 (1475)9260 (2215)12350 (2950)
Osmolality [mOsm / kg]2170
Theoretical osmolarity [mOsm / l]1545
pH5.0–6.0

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 special is delivered in flexible multi-chamber bags that contain:

  • 625 ml (250 ml amino acid solution + 125 ml fat emulsion + 250 ml glucose solution)
  • 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)
Multi-chamber bag with protective packaging, tear notch, oxygen indicator and oxygen absorber

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: 5×625 ml, 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 AG

Carl-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

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