Nutriflex omega special novo

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NUTRIFLEX OMEGA SPECIAL NOVO (NUTRIFLEX OMEGA SPECIAL NOVO)

Composition:

Active substances: Ready-to-use emulsion for intravenous infusion, after mixing the contents of the chambers, contains:

From the upper chamber (glucose solution)	in 1000 ml	in 625 ml	in 1250 ml	in 1875 ml
Glucose, monohydrate, equivalent to anhydrous glucose	158.4 g 144.0 g	99.00 g 90.00 g	198.0 g 180.0 g	297.0 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
Medium-chain triglycerides	20.00 g	12.50 g	25.00 g	37.50 g
Refined soybean oil	16.00 g	10.00 g	20.00 g	30.00 g
Omega-3 fatty acid triglycerides	4.000 g	2.500 g	5.000 g	7.500 g
From the lower 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 3.186 g	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, monohydrate, equivalent to histidine	2.368 g 1.753 g	1.480 g 1.095 g	2.960 g 2.191 g	4.440 g 3.286 g
Alanine	6.792 g	4.245 g	8.490 g	12.73 g
Aspartic acid	2.100 g	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 (mmol)	in 1000 ml	in 625 ml	in 1250 ml	in 1875 ml
Sodium	53.6	33.5	67	100.5
Potassium	37.6	23.5	47	70.5
Magnesium	4.2	2.65	5.3	7.95
Calcium	4.2	2.65	5.3	7.95
Zinc	0.03	0.02	0.04	0.06
Chlorides	48	30	60	90
Acetates	48	30	60	90
Phosphates	16	10	20	30

	in 1000 ml	in 625 ml	in 1250 ml	in 1875 ml
Content of amino acids	56.0 g	35.0 g	70.1 g	105.1 g
Content of nitrogen	8 g	5 g	10 g	15 g
Content of carbohydrates	144 g	90 g	180 g	270 g
Content of lipids	40 g	25 g	50 g	75 g

	in 1000 ml	in 625 ml	in 1250 ml	in 1875 ml
Energy in the form of lipids [kJ (kcal)]	1590 (380)	995 (240)	1990 (475)	2985 (715)
Energy in the form of carbohydrates [kJ (kcal)]	2415 (575)	1510 (360)	3015 (720)	4520 (1080)
Energy in the form of amino acids [kJ (kcal)]	940 (225)	585 (140)	1170 (280)	1755 (420)
Non-protein energy [kJ (kcal)]	4005 (955)	2505 (600)	5005 (1195)	7510 (1795)
Total energy value [kJ (kcal)]	4945 (1180)	3090 (740)	6175 (1475)	9260 (2215)

Osmolality [mOsm/kg]	2115
Theoretical osmolarity [mOsm/L]	1545
pH	5.0–6.0

Excipients: citric acid monohydrate; glycerin; egg lecithin; sodium oleate; sodium hydroxide (for pH adjustment); alpha-tocopherol; water for injections.

Pharmaceutical form. Infusion emulsion.

Main physico-chemical properties:

Amino acid chamber: clear solution, colorless to pale yellow, free from particles;

Glucose chamber: clear solution, colorless to pale yellow, free from particles;

Lipid emulsion chamber: white, milk-like emulsion.

Pharmacotherapeutic group. Parenteral nutrition solutions. Combinations of solutions. ATC code B05B A10.

Pharmacological Properties

Pharmacodynamics

Mechanism of action

The goal of parenteral nutrition is to supply all necessary nutrients and energy for growth and/or tissue regeneration, as well as for maintaining all bodily functions.

Amino acids are particularly important in this context, as some of them are essential components in protein synthesis. Simultaneous administration of energy sources (carbohydrates/lipids) is necessary to spare amino acids for tissue regeneration and anabolism, and to prevent their use as an energy source.

Glucose is widely metabolized throughout the body. Certain tissues and organs, such as the central nervous system, bone marrow, erythrocytes, and tubular epithelium, meet their energy requirements exclusively through glucose. In addition, glucose acts as a structural component of various cellular substances.

Due to their high energy density, lipids are an efficient source of energy supply. Long-chain triglycerides provide the body with essential fatty acids required for the synthesis of cellular components. To this end, the lipid emulsion contains both medium- and long-chain triglycerides (derived from soybean oil and fish oil).

The long-chain triglyceride fraction contains omega-6 and omega-3 triglycerides to ensure the supply of polyunsaturated fatty acids. These are primarily intended to prevent and treat essential amino acid deficiency, but also serve as an energy source. Nutriflex Omega Special Novum contains essential omega-6 fatty acids, mainly in the form of linoleic acid, and omega-3 fatty acids in the form of alpha-linolenic acid, eicosapentaenoic acid, and docosahexaenoic acid. The omega-6/omega-3 fatty acid ratio in Nutriflex Omega Special Novum is approximately 2.5:1.

Medium-chain triglycerides are hydrolyzed, cleared from the bloodstream, and completely oxidized more rapidly than long-chain triglycerides. They serve as a preferred energy source, especially in cases of impaired breakdown and/or utilization of long-chain triglycerides, such as in lipoprotein lipase deficiency and/or deficiency of lipoprotein lipase cofactors.

Preclinical studies with Nutriflex Omega Special Novum have not been conducted.

Toxic effects of nutrient mixtures used as replacement therapy at recommended doses are not expected.

Pharmacokinetics

Absorption

Nutriflex Omega Special Novum is administered intravenously. Thus, all substrates are immediately incorporated into metabolism.

Distribution

Dose, infusion rate, metabolic status, and patient-specific factors (degree of depletion) are critical for achieving maximum triglyceride concentration. When administered according to recommended dosing, triglyceride concentration generally does not exceed 4.6 mmol/L (400 mg/dL).

Medium-chain fatty acids have low affinity for albumin. Animal experiments with pure medium-chain triglyceride emulsions have shown that medium-chain fatty acids may penetrate the blood-brain barrier in cases of overdose. However, no adverse reactions have been observed with emulsions combining medium-chain and long-chain triglycerides, as long-chain triglycerides inhibit the hydrolysis of medium-chain triglycerides. Therefore, neurotoxic effects after administration of Nutriflex Omega Special Novum can be ruled out.

Amino acids are components of a wide range of proteins in various organs of the body. In addition, each amino acid is present in free form in blood and within cells.

Since glucose is water-soluble, it is distributed throughout the body via the bloodstream. Initially, the glucose solution spreads within the intravascular space and subsequently enters the intracellular space.

There are no available data on the passage of components/metabolites of Nutriflex Omega Special Novum across the placental barrier or into breast milk.

Biotransformation

Amino acids not involved in protein synthesis are metabolized via the following pathways. The amino group is separated from the carbon skeleton through transamination. The carbon chain is either directly oxidized to CO₂ or used by the liver as a substrate for gluconeogenesis. The amino group is also metabolized in the liver to urea.

Glucose is metabolized to CO₂ and H₂O via well-known metabolic pathways. A portion of glucose is used for lipid synthesis.

After infusion, triglycerides are hydrolyzed into glycerol and fatty acids. Both groups of compounds participate in physiological processes of energy production, synthesis of biologically active molecules, gluconeogenesis, and re-synthesis of lipids.

Specifically, long-chain omega-3 polyunsaturated fatty acids replace arachidonic acid as eicosanoid substrates in cell membranes, thereby reducing the production of inflammatory eicosanoids and cytokines in the body. This may be beneficial for patients at risk of developing a hyperinflammatory state or sepsis.

Elimination

Only a small amount of amino acids is excreted unchanged in urine.

Excess glucose is excreted in urine only if the renal glucose threshold is exceeded.

Both soybean oil triglycerides and medium-chain triglycerides are completely metabolized to CO₂ and H₂O. A minimal amount of lipids is lost only through desquamation of skin cells and other epithelial membranes. Renal excretion of lipids does not occur.

Clinical characteristics.

Indications.

Nutriflex Omega Special novo is indicated to provide energy, essential fatty acids including omega-3 and omega-6 fatty acids, amino acids, electrolytes, and fluid for parenteral nutrition in adults with moderate to severe catabolic states when oral or enteral nutrition is impossible, inadequate, or contraindicated.

Contraindications.

• Hypersensitivity to the active substances, egg, fish, peanut, or soy proteins, or to any other component of the medicinal product;
• Inborn errors of amino acid metabolism;
• Severe hyperlipidemia characterized by hypertriglyceridemia (≥ 1000 mg/dL, or 11.4 mmol/L);
• Severe coagulopathy;
• Hyperglycemia unresponsive to insulin doses up to 6 units/hour;
• Acidosis;
• Intrahepatic cholestasis;
• Severe hepatic insufficiency;
• Severe renal insufficiency in the absence of renal replacement therapy;
• Acute exacerbation of hemorrhagic diathesis;
• Acute thromboembolic events, fat embolism.

Nutriflex Omega Special novo should not be used in newborns, infants, and children under 2 years of age due to its composition.

General contraindications for parenteral nutrition:

• Unstable circulatory status with life-threatening risk (conditions of collapse or shock);
• Acute phase of myocardial infarction and stroke;
• Unstable metabolic state (e.g., severe post-aggression syndrome, coma of unknown origin);
• Inadequate cellular oxygen supply;
• Electrolyte or fluid imbalance;
• Acute pulmonary edema;
• Decompensated heart failure.

Interaction with other medicinal products and other forms of interaction.

Certain drugs, such as insulin, may affect the body's lipase system. However, this type of interaction may have only limited clinical significance.

Heparin, at clinical doses, causes a transient release of lipoprotein lipase into the bloodstream. This may initially increase plasma lipolysis, followed by a transient reduction in triglyceride clearance.

Soybean oil contains a natural amount of vitamin K1. This may influence the therapeutic effect of coumarin derivatives, which should be closely monitored in patients receiving such agents.

Solutions containing potassium, such as Nutriflex Omega Special novo, should be used with caution in patients receiving medicinal products that increase serum potassium concentrations, such as potassium-sparing diuretics (e.g., triamterene, amiloride, spironolactone), ACE inhibitors (e.g., captopril, enalapril), angiotensin-II receptor antagonists (e.g., losartan, valsartan), cyclosporine, and tacrolimus.

The use of corticosteroids and adrenocorticotropic hormone is associated with sodium and fluid retention.

Nutriflex Omega Special novo should not be administered simultaneously with blood using the same infusion set due to the risk of pseudoagglutination (see also section "Special precautions for use").

Special precautions for use.

Caution should be exercised in cases of increased serum osmolarity.

Fluid, electrolyte, or acid-base imbalances should be corrected prior to initiating infusion.

Too rapid administration may lead to fluid overload with pathological electrolyte concentrations in blood serum, hyperhydration, and pulmonary edema.

Any signs or symptoms of anaphylactic reaction (such as fever, tremor, rash, or dyspnea) require immediate discontinuation of the infusion.

During infusion of Nutriflex Omega Special Novo, special monitoring of serum triglyceride concentration is required.

Depending on the patient's metabolic status, hypertriglyceridemia may occasionally occur. If plasma triglyceride concentration exceeds 4.6 mmol/L (400 mg/dL) during lipid administration, the infusion rate should be reduced. Infusion must be interrupted if plasma triglyceride concentration exceeds 11.4 mmol/L (1000 mg/dL), as these levels are associated with acute pancreatitis.

Patients with lipid metabolism disorders

Nutriflex Omega Special Novo should be administered with caution to patients with lipid metabolism disorders and elevated serum triglyceride levels, such as those with renal insufficiency, diabetes mellitus, pancreatitis, hepatic dysfunction, hypothyroidism (with hypertriglyceridemia), sepsis, and metabolic syndrome. When Nutriflex Omega Special Novo is administered to patients in such conditions, careful monitoring of serum triglyceride levels is mandatory to ensure triglyceride clearance and maintain a stable triglyceride level below 11.4 mmol/L (1000 mg/dL). In combined hyperlipidemia and metabolic syndrome, triglyceride levels may respond to glucose, lipids, and excessive food intake. Dose adjustment is required. Other sources of lipids and glucose, as well as medications interfering with their metabolism, should be evaluated and controlled.

The presence of hypertriglyceridemia 12 hours after lipid administration also indicates lipid metabolism disorders.

Administration of Nutriflex Omega Special Novo, as with all solutions containing carbohydrates, may lead to hyperglycemia. Blood glucose levels should be monitored. In case of hyperglycemia, the infusion rate should be reduced or insulin administered. If the patient is simultaneously receiving other intravenous glucose solutions, the amount of additional glucose administered should be taken into account.

Infusion should also be discontinued if blood glucose concentration exceeds 14 mmol/L (250 mg/dL) during administration.

Refeeding or resumption of nutrition in malnourished patients or those who have been poorly nourished may cause hypokalemia, hypophosphatemia, or hypomagnesemia.

Careful monitoring of serum electrolyte levels is mandatory. Adequate supplementation of electrolytes according to deviations from normal values is required.

Monitoring of serum electrolyte concentrations, fluid balance, acid-base balance, blood count, coagulation status, and liver and kidney function is necessary.

Correction of electrolytes, vitamins, and trace elements may be required as needed. Since Nutriflex Omega Special Novo contains zinc and magnesium, calcium, and phosphates, caution should be exercised when co-administering with other solutions containing these elements.

Nutriflex Omega Special Novo should not be administered simultaneously with blood through the same infusion set due to the risk of pseudoagglutination (see also section "Interaction with other medicinal products and other forms of interaction").

Nutriflex Omega Special Novo is a complex formulation. Therefore, it is strongly recommended not to add other solutions unless compatibility has been demonstrated (see section "Incompatibilities").

As with all intravenous solutions, especially those for parenteral nutrition, strict adherence to aseptic techniques is required during infusion of Nutriflex Omega Special Novo.

Children

There is no clinical experience with the use of Nutriflex Omega Special Novo in children and adolescents.

Elderly patients

Generally, the same dose as for adults is used; however, caution is required when administering to patients with cardiac or renal insufficiency, which may be associated with advanced age.

Patients with diabetes mellitus, cardiac or renal insufficiency

Nutriflex Omega Special Novo should be used with caution in patients with cardiac or renal insufficiency, as with all large-volume infusion solutions.

Experience with its use in patients with diabetes mellitus or renal insufficiency is limited.

This medicinal product contains 1.244 mg of sodium per 1 mL, equivalent to 0.062% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

The maximum daily dose of this medicinal product for an adult weighing 70 kg is equivalent to 152% of the WHO recommended maximum daily sodium intake.

Nutriflex Omega Special Novo is considered a sodium-rich preparation. This should be particularly considered if the patient is on a low-salt diet.

Effect on laboratory test results

The fat content may interfere with certain laboratory tests (e.g., bilirubin, lactate dehydrogenase, oxygen saturation) if blood is sampled before fat is adequately cleared from the circulation.

Use during pregnancy or breastfeeding.

Pregnancy

Data on the effects of Nutriflex Omega Special Novo during pregnancy are limited. Animal studies are insufficient regarding reproductive toxicity (see section "Pharmacodynamics"). Parenteral nutrition may be necessary during pregnancy. Nutriflex Omega Special Novo may be administered to pregnant women only after careful benefit-risk assessment.

Breastfeeding period

Components/metabolites of Nutriflex Omega Special Novo pass into breast milk; however, when used at therapeutic doses, no effect on newborns/infants who are breastfed is expected. However, breastfeeding is not recommended for women receiving parenteral nutrition.

Fertility

There are no data on effects on fertility with the use of Nutriflex Omega Special Novo.

Ability to affect reaction speed when driving or operating machinery.

Nutriflex Omega Special Novo has no effect or a negligible effect on the ability to drive vehicles or operate machinery.

Method of Administration and Dosage

Dosage

Dosage must be individually adjusted according to the patient's specific needs.

Nutriflex Omega Special novo is recommended to be administered continuously. The infusion rate should be gradually increased over the first 30 minutes to the desired level to avoid potential complications.

Adults

The maximum daily dose is 35 mL/kg body weight, corresponding to:

• 2.0 g amino acids/kg body weight per day;
• 5.04 g glucose/kg body weight per day;
• 1.4 g lipids/kg body weight per day.

The maximum infusion rate is 1.7 mL/kg body weight per hour, corresponding to:

• 0.1 g amino acids/kg body weight per hour;
• 0.24 g glucose/kg body weight per hour;
• 0.07 g lipids/kg body weight per hour.

For a patient weighing 70 kg, this corresponds to an infusion rate of 119 mL/hour. The amount of infused substrate is 6.8 g amino acids per hour, 17.1 g glucose per hour, and 4.8 g lipids per hour.

Children

Newborns, infants, and children under 2 years of age

Nutriflex Omega Special novo is contraindicated in newborns, infants, and children under 2 years of age in whom the amino acid may be considered conditionally essential (see section "Contraindications").

Patients with hepatic or renal impairment

Dosage should be individually adjusted in patients with hepatic or renal impairment (see section "Special Warnings and Precautions for Use").

Patients receiving intradialytic parenteral nutrition (IDPN)

Intradialytic parenteral nutrition is intended for patients undergoing dialysis who do not have acute illnesses and suffer from malnutrition, for whom nutritional counseling or treatment with oral nutritional supplements has been ineffective.

The appropriate volume of Nutriflex Omega Special novo to be used for IDPN should be based on the gap between spontaneous intake and recommended intake. In addition, metabolic tolerance must be considered. The maximum infusion rate of Nutriflex Omega Special novo for patients receiving IDPN is 2.3 mL/kg/hour, corresponding to 0.13 g/kg/hour amino acids, 0.33 g/kg/hour glucose, and 0.092 g/kg/hour lipids, administered over 4 hours. Due to known losses of amino acids (retention rate 73%) and glucose (25 g per 4-hour dialysis session) during dialysis, the patient ultimately receives 0.095 g/kg/hour amino acids, 0.24 g/kg/hour glucose, and 0.092 g/kg/hour lipids. For a patient weighing 70 kg undergoing a 4-hour dialysis session, this corresponds to 27 g amino acids, 67 g glucose, 26 g lipids in 644 mL of fluid.

Treatment Duration

The duration of treatment for the recommended indications is not limited. With prolonged use of Nutriflex Omega Special novo, adequate replacement of trace elements and vitamins must be ensured.

Infusion Duration from One Bag

The recommended duration of infusion from one parenteral nutrition bag is a maximum of 24 hours.

Route of Administration

Intravenous administration. For infusion into a central vein only.

During IDPN, the bag contents should be administered via the venous line of the extracorporeal circulation.

Preparation of the Mixed Emulsion

Strict aseptic techniques must be followed throughout all procedures.

Opening

Before opening the protective film of the package, check the color of the oxygen indicator. Do not use if the oxygen indicator has turned pink. Use only if the oxygen indicator is yellow.

Tear the outer package film along the perforation line.

Remove the bag from the outer package.

Dispose of the outer package, oxygen indicator, and oxygen absorber.

Visually inspect the primary bag for leaks. Discard any leaking bag, as sterility cannot be guaranteed.

Mixing the Bag Contents and Adding Additives

To open the compartments and mix their contents sequentially, twist the bag with both hands, starting from the seal separating the upper glucose chamber and the lower amino acid chamber. Then continue pressing to open the seal between the middle lipid chamber and the lower chamber.

After mixing the contents of all compartments and removing the aluminum seal, compatible additives may be added through the medication port. Mix the bag contents thoroughly and visually inspect the mixture. The resulting solution is a white, milk-like "oil-in-water" emulsion. There should be no signs of emulsion phase separation.

Nutriflex Omega Special novo may be mixed with the following additives up to the upper concentration limits or maximum additive amounts specified below:

The resulting solution is stable for 7 days at 2–8 °C and an additional 2 days if further stored at 25 °C.

• Electrolytes: consider the electrolytes already present in the infusion bag; stability has been demonstrated up to a total of 200 mmol/L sodium + potassium (combined), 9.6 mmol/L magnesium, and 6.4 mmol/L calcium in the three-component mixture.
  • Phosphates: stability has been demonstrated up to a maximum concentration of 20 mmol/L for inorganic phosphate or up to 30 mmol/L for organic phosphate (but not both simultaneously).
  • Alanyl-glutamine: up to 24 g/L.
  • Trace elements and vitamins: stability has been demonstrated with multitrace elements and multivitamins (e.g., Tracutil, Cernevit) at standard manufacturer-recommended doses.

Detailed information on the above additives and their respective shelf life can be provided by the manufacturer upon request.

Preparation for Infusion

The emulsion should always be warmed to room temperature before infusion.

Remove the protective aluminum foil from the infusion port and connect the infusion set.

Use an infusion set without a venting valve or close the venting port if using a set with a venting valve.

Hang the infusion bag on an IV stand and administer by standard infusion technique.

For single use only.

The bag and any unused portions must be discarded after use.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Do not reconnect a bag containing partially used medicinal product.

If filters are used, they must be lipid-permeable (pore size ≥ 1.2 μm).

Parenteral nutrition products should be visually inspected before use for packaging damage, color change, and emulsion instability.

Do not use a damaged bag. The outer package film, primary bag, and seals between compartments must be intact. Use only if the amino acid and glucose solutions are clear, colorless to pale yellow, and the lipid emulsion is white and milk-like. Do not use if the solutions contain particulate matter.

Do not use the medicinal product after mixing the three chambers if the emulsion has changed color or shows signs of phase separation (oil droplets, oil layer). Immediately discontinue infusion if color change or phase separation occurs. Before opening the protective package film, check the color of the oxygen indicator. Do not use if the oxygen indicator has turned pink. Use only if the oxygen indicator is yellow.

Children

Nutriflex Omega Special novo should not be used in newborns, infants, and children under 2 years of age due to its composition (see section "Contraindications").

Overdose

Symptoms of fluid and electrolyte overdose

Hyperhydration, electrolyte imbalance, and pulmonary edema.

Symptoms of amino acid overdose

Renal excretion of amino acids leading to amino acid imbalance, nausea, vomiting, and tremor.

Symptoms of glucose overdose

Hyperglycemia, glucosuria, dehydration, hyperosmolarity, hyperglycemic-hyperosmolar coma.

Symptoms of lipid overdose

Described in the section "Adverse Reactions."

Treatment

In case of overdose, immediate discontinuation of the infusion is indicated. Further therapeutic measures depend on the specific symptoms and their severity. If re-initiation of infusion is necessary after symptom resolution, it is recommended to gradually increase the infusion rate with frequent monitoring.

Adverse Reactions

Even when used correctly, adhering to safety rules and instructions for use, adverse reactions may still occur. Below is a list of systemic reactions that may be associated with the use of the medicinal product Nutriflex Omega Special Neo.

Adverse reactions are listed according to their frequency of occurrence:

Very common (≥ 1/10)
Common (≥ 1/100 to < 1/10)
Uncommon (≥ 1/1000 to < 1/100)
Rare (≥ 1/10000 to < 1/1000)
Very rare (< 1/10000)
Not known (frequency cannot be estimated from available data)

Blood and lymphatic system disorders

Rare: hypercoagulation
Not known: leukopenia, thrombocytopenia

Immune system disorders

Rare: allergic reactions (including anaphylactic reactions, skin rashes, swelling of the throat, oral cavity, and face)

Metabolism and nutrition disorders

Uncommon: loss of appetite
Very rare: hyperlipidemia, hyperglycemia, metabolic acidosis. The frequency of these adverse reactions is dose-dependent and may increase under conditions of absolute or relative lipid overdose.

Nervous system disorders

Rare: headache, somnolence

Vascular disorders

Rare: hypertension or hypotension, hot flushes

Respiratory system disorders

Rare: dyspnea, cyanosis

Gastrointestinal disorders

Uncommon: nausea, vomiting

Hepatobiliary disorders

Not known: cholestasis

Skin and subcutaneous tissue disorders

Rare: erythema, sweating

Musculoskeletal and connective tissue disorders

Rare: back, bone, shoulder, and lumbar pain

General disorders and administration site conditions

Rare: increased body temperature, feeling of cold, chills
Very rare: fat overload syndrome (detailed information provided below)

If any of these adverse reactions occur, the infusion should be discontinued.

If serum triglyceride levels rise to 11.4 mmol/L (1000 mg/dL) during infusion, the infusion should be stopped. If levels are above 4.6 mmol/L (400 mg/dL), the infusion may continue but at reduced doses (see section "Special precautions for use").

If the infusion is restarted, the patient should be closely monitored, especially at the beginning, and serum triglyceride levels should be checked at regular intervals.

Information on specific adverse reactions

Nausea, vomiting, and loss of appetite are symptoms commonly associated with conditions requiring parenteral nutrition, but they may also be related to parenteral nutrition itself.

Fat Overload Syndrome

Reduced ability to eliminate triglycerides may lead to fat overload syndrome, which may be caused by overdose. Signs of metabolic overload should be observed. Causes may include genetic disorders (individual metabolic differences), or existing or previous diseases affecting lipid metabolism. This syndrome may also occur in severe hypertriglyceridemia, even when the recommended infusion rate is followed, and in connection with sudden changes in the patient's clinical condition, such as renal dysfunction or infection. Fat overload syndrome is characterized by hyperlipidemia, fever, fatty infiltration, hepatomegaly with or without jaundice, splenomegaly, anemia, leukopenia, thrombocytopenia, coagulation disorders, hemolysis, reticulocytosis, abnormal liver function tests, and coma. These symptoms are usually reversible after discontinuation of the fat emulsion infusion.

If symptoms of fat overload syndrome occur, administration of Nutriflex Omega Special Neo must be stopped immediately.

Reporting suspected adverse reactions

Reporting suspected adverse reactions after medicinal product authorization is important. This allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, as well as their legal representatives, should report any suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua

Shelf life

Unopened bag: 2 years.

After removal of the protective film from the outer pouch and after mixing the bag chambers: chemical and physical stability of the amino acid, glucose, and fat mixture has been demonstrated for 7 days when stored at 2–8 °C, and for an additional 2 days at 25 °C.

After addition of compatible additives: from a microbiological standpoint, the medicinal product should be used immediately after addition of compatible additives. If not administered immediately after additive addition, responsibility for storage duration and conditions prior to use lies with the user.

After first opening (puncture of the infusion port): the emulsion should be used immediately after first opening of the bag.

Storage conditions

Store at temperatures not exceeding 25 °C.
Do not freeze. If the bag contents freeze accidentally, the product must be discarded.
Store the bag in its outer packaging in a place protected from light.

Incompatibilities

This medicinal product must not be mixed with other medicinal products whose compatibility has not been documented (see section "Dosage and administration").

Nutriflex Omega Special Neo must not be administered simultaneously with blood products (see sections "Special precautions for use" and "Interaction with other medicinal products and other forms of interaction").

Packaging

625 ml (250 ml amino acid solution + 125 ml fat emulsion + 250 ml glucose solution) in a flexible multi-chamber bag made of multilayer foil; 5 bags per cardboard box.

1250 ml (500 ml amino acid solution + 250 ml fat emulsion + 500 ml glucose solution) in a flexible multi-chamber bag made of multilayer foil; 5 bags per cardboard box.

1875 ml (750 ml amino acid solution + 375 ml fat emulsion + 750 ml glucose solution) in a flexible multi-chamber bag made of multilayer foil; 5 bags per cardboard box.

Prescription status
By prescription only.

Manufacturer
B. Braun Melsungen AG / B. Braun Melsungen AG

Manufacturer's address and place of business
Am Schwerzelshof 1, 34212 Melsungen, Germany / Am Schwerzelshof 1, 34212 Melsungen, Germany