Nutriflex (Emulsion) Instructions for Use
ATC Code
B05BA10 (Combined preparations for parenteral nutrition)
Clinical-Pharmacological Group
Drug for total parenteral nutrition – solution of amino acids, fats, carbohydrates, electrolytes
Pharmacotherapeutic Group
Parenteral nutrition agent
Pharmacological Action
Amino acid solutions for parenteral nutrition provide the body with substrates for protein synthesis.
The administration of all amino acids necessary for protein synthesis (including essential, conditionally essential, and non-essential amino acids) ensures high nutritional efficiency and reduces the metabolic burden on the body associated with protein synthesis.
In addition to amino acids, parenteral nutrition preparations may include minerals, dextrose, xylitol, and lipids.
Minerals are necessary for maintaining water-electrolyte and acid-base balance.
As an energy source, amino acid solutions for parenteral nutrition may contain dextrose, xylitol, sorbitol, which are involved in the processes of glycolysis and gluconeogenesis.
Fat emulsion is a source of energy and essential fatty acids.
Indications
For parenteral nutrition in inpatient and outpatient settings to cover the daily requirements of patients for amino acids, electrolytes, and fluids during parenteral nutrition in patients with moderate to severe catabolism in cases where enteral nutrition is impossible, insufficient, or contraindicated, as well as in combination with it.
Parenteral nutrition agents should be used strictly in accordance with the indications in the medical instructions for use.
ICD codes
| ICD-10 code | Indication |
| E46 | Unspecified protein-energy malnutrition |
| E63.8 | Other specified types of nutritional deficiency |
| R63.3 | Feeding difficulties and mismanagement of food intake |
| ICD-11 code | Indication |
| 5B50 | Deficiency of weight in infants, children and adolescents |
| 5B51 | Exhaustion in infants, children and adolescents |
| 5B52 | Acute protein-energy malnutrition in infants, children and adolescents |
| 5B53 | Growth delay in infants, children and adolescents |
| 5B54 | Underweight in adults |
| 5B71 | Protein deficiency |
| 5B7Z | Malnutrition, unspecified |
| 8D40.0 | Encephalopathy due to nutritional deficiency |
| MG43.3Z | Unspecified feeding difficulties |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Administer intravenously via a central or large peripheral vein.
Determine the dosage based on the patient’s body weight, clinical condition, and nutritional requirements.
Calculate the daily volume to meet the patient’s needs for energy, amino acids, electrolytes, and fluids.
Infuse at a constant rate using an infusion pump; do not administer as a bolus.
For adults, the typical infusion rate ranges from 0.5 to 1.5 mL/kg/hour initially; adjust according to tolerance.
Closely monitor for signs of intolerance, including hyperglycemia, hypertriglyceridemia, and fluid overload.
Regularly assess blood glucose, electrolytes, liver and renal function during therapy.
For pediatric patients, use only formulations specifically designed for this age group.
Adjust the infusion rate in pediatric populations to avoid metabolic complications and amino acid loss.
Terminate infusion immediately if allergic reactions or signs of infection at the infusion site occur.
Adverse Reactions
Immune system disorders allergic reactions.
Cardiovascular system disorders phlebitis, thrombosis.
Respiratory system disorders bronchospasm.
Digestive system disorders nausea, vomiting.
Urinary system disorders renal aminoacidosis.
General disorders chills, redness.
Contraindications
General for parenteral nutrition: severe circulatory disorders (collapse and shock); pronounced tissue hypoxia; overhydration; water-electrolyte balance disorders; pulmonary edema; decompensated heart failure, severe renal failure; acute period of traumatic brain injury; coma or impaired brain functions that may cause a comatose state.
Before prescribing a parenteral nutrition preparation, contraindications for its use in a particular patient should be carefully studied.
With caution
Patients with increased plasma osmolarity, heart failure, hepatic and/or renal failure.
In children and adolescents under 18 years of age, only those parenteral nutrition preparations that are intended for the corresponding age category should be used.
Use in Pregnancy and Lactation
If it is necessary to prescribe a parenteral nutrition preparation during pregnancy, the presence of contraindications for use and precautions in the current clinical situation should be taken into account.
The use of parenteral nutrition solutions during lactation (breastfeeding) is not recommended.
Pediatric Use
In children and adolescents under 18 years of age, only those parenteral nutrition preparations that are intended for the corresponding age category should be used.
Special Precautions
Intravenous administration of amino acid solutions is accompanied by increased urinary excretion of trace elements, especially copper and zinc. This must be taken into account when selecting doses of trace elements, especially during long-term therapy.
When administering a parenteral nutrition preparation, regular monitoring of water-electrolyte balance and blood acid-base status, blood sugar concentration, and serum ionogram should be performed. During long-term therapy, monitoring of blood parameters (coagulogram, liver function parameters) is necessary.
Due to the risk of pseudoagglutination, it is not recommended to use the same infusion systems for the administration of blood products and multicomponent amino acid solutions.
Use in pediatrics
During parenteral nutrition of young children, the following parameters must be taken into account: urine nitrogen, ammonia, glucose, electrolytes, triglycerides (with additional administration of fat emulsions), liver enzymes, serum osmolarity, acid-base balance, and water-salt metabolism. Too rapid infusion can lead to the loss of amino acids through the kidneys and, as a result, to an imbalance of amino acids.
In pediatrics, only those parenteral nutrition preparations that are intended for this category of patients should be used.
Drug Interactions
Parenteral nutrition preparations are multicomponent solutions. When adding other solutions or a lipid emulsion to the preparation used, the compatibility of all ingredients must be taken into account.
Simultaneous administration of arginine with thiazide diuretics and aminophylline increases the insulin content in the blood.
Estrogens and oral contraceptives can increase the concentration of growth hormone caused by arginine and reduce the glucagon and insulin response to arginine.
With simultaneous use of arginine with spironolactone, the development of severe hyperkalemia is possible.
Storage Conditions
Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Rx Only
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Emulsion for infusion: 1250 ml, 1875 ml or 2500 ml plastic triple containers 5 pcs.
Marketing Authorization Holder
B.Braun Melsungen AG (Germany)
Dosage Form
 |
Nutriflex 48/150 lipid | Emulsion for infusion: 1250 ml, 1875 ml or 2500 ml plastic triple containers 5 pcs. |
Dosage Form, Packaging, and Composition
Emulsion for infusion – amino acid and glucose solutions with electrolytes: transparent, pale yellow or yellow solutions; fat emulsion: oil-in-water emulsion of milky white color.
| 1 L | |
| Isoleucine | 2.26 g |
| Leucine | 3.01 g |
| Lysine (as hydrochloride) | 2.18 g |
| Methionine | 1.88 g |
| Phenylalanine | 3.37 g |
| Threonine | 1.74 g |
| Tryptophan | 0.54 mg |
| Valine | 2.5 g |
| Arginine | 2.59 g |
| Histidine | 1.2 g |
| Glycine | 1.58 g |
| Alanine | 4.66 g |
| Proline | 3.26 g |
| Aspartic acid | 1.44 g |
| Glutamic acid | 3.37 g |
| Serine | 2.88 g |
| Sodium hydroxide | 0.781 g |
| Sodium chloride | 0.402 mg |
| Sodium phosphate monobasic dihydrate | 1.872 g |
| Sodium acetate trihydrate | 0.222 g |
| Potassium acetate | 2.747 g |
| Magnesium acetate tetrahydrate | 0.686 g |
| Calcium chloride dihydrate | 0.47 g |
| Zinc acetate dihydrate | 5.264 mg |
| Medium-chain triglycerides | 20 g |
| Soybean oil | 20 g |
| Dextrose (as monohydrate) | 120 g |
| Emulsion after mixing the contents of the container chambers contains | |
| Amino acids | 38.4 g |
| Carbohydrates | 120 g |
| Fats | 40 g |
| Total nitrogen | 5.44 g |
| Energy value | |
| Amino acids | 640 kJ (152 kcal) |
| Carbohydrates | 2008 kJ (480 kcal) |
| Fats | 1592 kJ (380 kcal) |
| Non-protein energy value | 3600 kJ (860 kcal) |
| Total energy value | 4240 kJ (1012 kcal) |
| Electrolyte concentration | |
| Sodium | 40 mmol |
| Potassium | 28 mmol |
| Calcium | 3.2 mmol |
| Magnesium | 3.2 mmol |
| Zinc | 0.024 mmol |
| Chlorides | 36 mmol |
| Acetates | 36 mmol |
| Phosphates | 12 mmol |
Excipients : citric acid monohydrate 0-0.336 g, glycerol 5 g, egg lecithin 2.4 g, sodium oleate 0.06 g, water for injections – up to 1000 ml.
Osmolality: 1540 mOsm/kg.
PH: 5.0 – 6.0.
1250 ml – plastic triple-chamber containers (1) – plastic bags.
1875 ml – plastic triple-chamber containers (1) – plastic bags.
2500 ml – plastic triple-chamber containers (1) – plastic bags.
1250 ml – plastic triple-chamber containers (1) – plastic bags (5) – cardboard boxes.
1875 ml – plastic triple-chamber containers (1) – plastic bags (5) – cardboard boxes.
2500 ml – plastic triple-chamber containers (1) – plastic bags (5) – cardboard boxes.
Emulsion for infusion: 625 ml, 1250 ml, 1875 ml or 2500 ml plastic triple containers 1 or 5 pcs.
Marketing Authorization Holder
B.Braun Melsungen AG (Germany)
Dosage Form
|
Nutriflex 70/180 lipid | Emulsion for infusion: 625 ml, 1250 ml, 1875 ml or 2500 ml plastic triple containers 1 or 5 pcs. |
Dosage Form, Packaging, and Composition
Emulsion for infusion – amino acid and glucose solutions with electrolytes: transparent, pale yellow or yellow solutions; fat emulsion: oil-in-water emulsion of milky white color.
| 1 L | |
| Isoleucine | 3.28 g |
| Leucine | 4.38 g |
| Lysine (as hydrochloride) | 3.18 g |
| Methionine | 2.74 g |
| Phenylalanine | 4.92 g |
| Threonine | 2.54 g |
| Tryptophan | 0.8 mg |
| Valine | 3.6 g |
| Arginine | 3.78 g |
| Histidine | 1.75 g |
| Glycine | 2.31 g |
| Alanine | 6.79 g |
| Proline | 4.76 g |
| Aspartic acid | 2.1 g |
| Glutamic acid | 4.91 g |
| Serine | 4.2 g |
| Sodium hydroxide | 1.171 g |
| Sodium chloride | 0.378 mg |
| Sodium phosphate monobasic dihydrate | 2.496 g |
| Sodium acetate trihydrate | 0.25 g |
| Potassium acetate | 3.689 g |
| Magnesium acetate tetrahydrate | 0.91 g |
| Calcium chloride dihydrate | 0.623 g |
| Zinc acetate dihydrate | 7.02 mg |
| Medium-chain triglycerides | 20 g |
| Soybean oil | 20 g |
| Dextrose (as monohydrate) | 144 g |
| Emulsion after mixing the contents of the container chambers contains | |
| Amino acids | 57.5 g |
| Carbohydrates | 144 g |
| Fats | 40 g |
| Total nitrogen | 8 g |
| Energy value | |
| Amino acids | 936 kJ (224 kcal) |
| Carbohydrates | 2412 kJ (576 kcal) |
| Fats | 1592 kJ (380 kcal) |
| Non-protein energy value | 4004 kJ (956 kcal) |
| Total energy value | 4940 kJ (1180 kcal) |
| Electrolyte concentration | |
| Sodium | 53.6 mmol |
| Potassium | 37.6 mmol |
| Calcium | 4.24 mmol |
| Magnesium | 4.24 mmol |
| Zinc | 0.032 mmol |
| Chlorides | 48 mmol |
| Acetates | 48 mmol |
| Phosphates | 16 mmol |
Excipients : citric acid monohydrate 0-0.336 g, glycerol 5 g, egg lecithin 2.4 g, sodium oleate 0.06 g, water for injections – up to 1000 ml.
Osmolality: 2090 mOsm/kg.
PH: 5.0 – 6.0.
625 ml – plastic triple-chamber containers (1) – plastic bags.
1250 ml – plastic triple-chamber containers (1) – plastic bags.
1875 ml – plastic triple-chamber containers (1) – plastic bags.
2500 ml – plastic triple-chamber containers (1) – plastic bags.
625 ml – plastic triple-chamber containers (1) – plastic bags (5) – cardboard boxes.
1250 ml – plastic triple-chamber containers (1) – plastic bags (5) – cardboard boxes.
1875 ml – plastic triple-chamber containers (1) – plastic bags (5) – cardboard boxes.
2500 ml – plastic triple-chamber containers (1) – plastic bags (5) – cardboard boxes.
![Nutriflex [Emulsion] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Nutriflex [Emulsion] 2")