Nutriflex Lipid Peri (Emulsion) Instructions for Use

Marketing Authorization Holder

B.Braun Melsungen AG (Germany)

ATC Code

B05BA10 (Combined preparations for parenteral nutrition)

Dosage Form

Nutriflex Lipid Peri

Emulsion for infusion: containers 1250 ml, 1875 ml or 2500 ml (1 chamber – dextrose solution with electrolytes; 2 chamber – amino acid solution with electrolytes; 3 chamber – fat emulsion)

Dosage Form, Packaging, and Composition

* composition of the drug after mixing the contents of the container chambers in 1000 ml.

Excipients : citric acid monohydrate 0.134-0.336 g (corresponds to citric acid – 0.123-0.307 g), glycerol – 5.00 g, egg phospholipids for injection – 2.4 g, sodium oleate – 0. 060 g, α-tocopherol – 0.040 gwater for injection – up to 1000 ml.

1250 ml – plastic three-chamber containers (1) 1 chamber: Dextrose solution with electrolytes; 2 chamber: amino acid solution with electrolytes; 3 chamber: fat emulsion – plastic packages (5) – cardboard boxes (for hospitals).
1875 ml – plastic three-chamber containers (1) 1 chamber: Dextrose solution with electrolytes; 2 chamber: amino acid solution with electrolytes; 3 chamber: fat emulsion – plastic packages (5) – cardboard boxes (for hospitals).
2500 ml – plastic three-chamber containers (1) 1 chamber: Dextrose solution with electrolytes; 2 chamber: amino acid solution with electrolytes; 3 chamber: fat emulsion – plastic packages (1) – cardboard boxes (for hospitals).

Clinical-Pharmacological Group

Drug for total parenteral nutrition – solution of amino acids, fats, carbohydrates, electrolytes

Pharmacotherapeutic Group

Blood substitutes and perfusion solutions; solutions for intravenous administration; solutions for parenteral nutrition

Indications

• Nutriflex Lipid Peri is indicated for total parenteral nutrition (TPN) in adult patients when oral or enteral nutrition is not possible, insufficient, or contraindicated.
• It is specifically formulated for the perioperative period to provide nutritional support before and after surgery, helping to correct or prevent protein-calorie malnutrition and to meet the increased metabolic demands associated with surgical stress and recovery.
• The preparation is used to supply energy, essential amino acids, essential fatty acids, electrolytes, and trace elements, thereby supporting anabolic processes, tissue repair, and immune function in a clinical setting where the gastrointestinal tract cannot be utilized.

Contraindications

• Absolute Contraindications: Known hypersensitivity to any component of the emulsion, such as egg, soybean, or peanut proteins, or to any of the amino acids, lipids, or electrolytes present. Severe hyperlipidemia or severe disorders of lipid metabolism characterized by hypertriglyceridemia (e.g., serum triglycerides > 1000 mg/dL). Inborn errors of amino acid metabolism. Uncompensated cardiac insufficiency, severe hepatic failure, or severe renal failure requiring dialysis. Severe electrolyte imbalances where the administration of potassium, sodium, calcium, magnesium, or phosphate would be detrimental. Metabolic acidosis. Hemodynamic instability or shock.
• Relative Contraindications (Require Extreme Caution and Strict Medical Supervision): Mild to moderate hepatic or renal impairment. Compromised pulmonary function, particularly in patients at risk for fat overload syndrome. Acid-base imbalances. Diabetes mellitus or other conditions associated with glucose intolerance. Patients with known or suspected hypercoagulable states. Conditions associated with a risk of refeeding syndrome, requiring careful initiation and monitoring of nutritional support.

Dosage Regimen

The dosage of Nutriflex Lipid Peri is highly individualized and must be determined by a physician based on the patient’s clinical status, nutritional requirements, body weight, age, and metabolic tolerance. The regimen should be calculated to meet the patient’s daily needs for energy, amino acids (protein), fluids, and electrolytes.

The average daily dosage for an adult patient is typically 20 to 40 ml/kg body weight per day, which corresponds to approximately 15 to 30 kcal/kg/day and 0.8 to 1.6 g of amino acids/kg/day. The maximum infusion rate should not exceed 2.6 ml/kg body weight per hour (equivalent to approximately 2.0 kcal/kg/h and 0.08 g amino acids/kg/h) to ensure metabolic safety and tolerance.

The infusion should be administered intravenously via a central or peripheral vein, with the choice of access depending on the osmolarity of the final mixture and the planned duration of therapy. The contents of the three chambers must be thoroughly mixed immediately before administration by squeezing the bag until a homogeneous, milky-white emulsion is formed. The infusion set should be connected under aseptic conditions. The duration of infusion for one container (1250 ml, 1875 ml, or 2500 ml) should typically be 12 to 24 hours.

Close monitoring of the patient is essential, including fluid balance, blood glucose, serum electrolytes, liver and kidney function tests, triglyceride levels, and acid-base status, especially during the initial phase of therapy. The infusion rate should be reduced or temporarily discontinued if signs of intolerance appear.

Adverse Reactions

As with all parenteral nutrition formulations, adverse reactions may occur. They can be related to the method of administration (catheter-related), the components of the solution, or the patient’s underlying condition.

Common Adverse Reactions: Reactions at the infusion site, such as thrombophlebitis, pain, erythema, or swelling. Generalized reactions may include nausea, vomiting, headache, fever, chills, and sweating. Metabolic disturbances such as hyperglycemia, hypoglycemia (especially upon abrupt discontinuation), hypertriglyceridemia, and electrolyte imbalances (e.g., hyperkalemia, hypophosphatemia) can occur.

Serious Adverse Reactions:Fat Overload Syndrome: This is a rare but serious condition characterized by a sudden onset of hypertriglyceridemia, fever, fat infiltration in organs, hepatomegaly, splenomegaly, thrombocytopenia, and coagulation disorders. It requires immediate cessation of the lipid infusion. Allergic/Anaphylactic Reactions: Including dyspnea, cyanosis, urticaria, pruritus, rash, and hypotension, potentially due to hypersensitivity to egg, soybean, or other components. Refeeding Syndrome: Can occur in severely malnourished patients upon initiation of feeding, leading to severe shifts in electrolytes and fluid balance. Hepatobiliary Disorders: Liver function test abnormalities, cholestasis, and hepatic steatosis with prolonged use. Respiratory Complications: Dyspnea and pulmonary embolism risk in susceptible patients.

If any severe adverse reaction occurs, the infusion must be stopped immediately, and appropriate symptomatic and supportive treatment should be initiated.

Drug Interactions

Nutriflex Lipid Peri contains multiple active substances and may interact with concurrently administered medications. Additives should not be introduced into the infusion bag unless compatibility is known and the procedure is performed under aseptic conditions.

Electrolyte Interactions: The preparation contains significant amounts of potassium and other electrolytes. Concurrent use with potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor blockers, or other drugs that increase serum potassium levels can lead to severe hyperkalemia. Conversely, the use of loop diuretics or corticosteroids may increase potassium excretion.

Glucose and Insulin: The high dextrose content can cause hyperglycemia, often necessitating exogenous insulin administration. The insulin requirement may be altered. Close monitoring of blood glucose is mandatory. The effects of oral hypoglycemic agents may be potentiated.

Heparin can increase the clearance of triglycerides by activating lipoprotein lipase. While sometimes used to improve lipid clearance, it may alter the nutritional efficacy and requires monitoring.

Drugs Affecting Coagulation: The lipid component can affect platelet function and coagulation. Caution is advised when used with anticoagulants (e.g., warfarin) or antiplatelet agents, as the International Normalized Ratio (INR) may be affected.

Cyclosporine, Tacrolimus: The lipid emulsion can alter the pharmacokinetics of these immunosuppressants, potentially increasing their toxicity. Drug level monitoring is crucial.

Phenytoin: Serum levels may be reduced, potentially decreasing its anticonvulsant effect.

Direct Intravenous Compatibility: The Y-site compatibility with other intravenous medications should be verified before simultaneous administration through the same line. A separate infusion line is generally preferred.

Overdose

Overdose with Nutriflex Lipid Peri can lead to fluid overload, metabolic complications, and the consequences of excessive nutrient administration. The manifestations are often an exaggeration of the known adverse effects.

Symptoms of Overdose:Hyperglycemia and hyperosmolar hyperglycemic state, which can lead to dehydration, polyuria, and confusion. Hypertriglyceridemia and the potential development of fat overload syndrome. Electrolyte imbalances such as hyperkalemia, hyponatremia, hypophosphatemia, or hypercalcemia. Metabolic acidosis or alkalosis. Hepatic steatosis and elevated liver enzymes. Azotemia from excessive amino acid load in patients with compromised renal function. Cardiac failure due to fluid volume overload, especially in patients with pre-existing cardiac conditions.

Treatment of Overdose: There is no specific antidote. The infusion must be discontinued immediately. Treatment is entirely supportive and symptomatic. This includes correction of fluid and electrolyte imbalances, administration of insulin for hyperglycemia, and monitoring of vital signs and organ function. In cases of severe hypertriglyceridemia, plasmapheresis may be considered. Hemodialysis is not effective for removing the macronutrients but may be required to correct severe electrolyte disturbances or azotemia.

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.