CLINOLEIC 20% Emulsion for infusion

WARNINGS Any abnormal signs or symptoms of an allergic reaction (e.g., sweating, fever, chills, skin rash, headache, dyspnoea, etc.) should prompt immediate discontinuation of the infusion.​​​‍​​‍​​​​‍​​‍‍ Clinoleic contains soybean oil and egg phospholipids, which may cause hypersensitivity reactions. Cross-allergies between soy protein and peanut protein have been observed. Plasma triglyceride levels and their clearance must be monitored daily. Serum triglyceride concentrations should not exceed 3 mmol/l during infusion. The infusion should only be resumed once serum triglyceride levels have returned to baseline values. Exposure of intravenous parenteral nutrition solutions to light, particularly after the addition of trace elements and/or vitamins, may have adverse effects on clinical outcomes in neonates due to the generation of peroxides and other degradation products. When used in neonates and children under 2 years of age, Clinoleic should be protected from ambient light until administration is completed (see sections 4.2, 6.3, and 6.6). Complications – infection and sepsis Infection and sepsis at the administration site may be complications in patients receiving parenteral nutrition, particularly due to poor catheter care, contaminated solutions, immunosuppression, and other factors such as hyperglycaemia, malnutrition, and/or underlying disease that may predispose patients to infectious complications. Thorough monitoring of signs, symptoms, and laboratory results for fever/chills, leucocytosis, technical complications at the administration site, and hyperglycaemia helps to identify early infection. Patients requiring parenteral nutrition are often predisposed to infectious complications due to malnutrition and/or underlying disease. The incidence of septic complications can be reduced by paying increased attention to aseptic technique during catheter placement and maintenance, as well as during the preparation of the nutritional product. Hepatic insufficiency Use with caution in patients with hepatic insufficiency due to the risk of developing or worsening neurological disorders associated with hyperammonaemia. Regular clinical and laboratory monitoring is required, particularly for blood glucose, electrolytes, and triglycerides (which should not exceed 3 mmol/l during infusion). Haematology and thrombophlebitis Use with caution in patients with coagulation disorders and anaemia. Blood counts and coagulation parameters should be closely monitored. Thrombophlebitis may develop, especially when administered via a peripheral vein. Local signs of thrombophlebitis at the catheter site must be checked daily. Reduced ability to eliminate lipids may result from "fat overload syndrome", which may be caused by overdose but may also occur at the start of infusion. These effects are usually reversible and resolve upon discontinuation of the lipid infusion (see section 4.8). Serious adverse reactions such as acute respiratory distress and metabolic acidosis have been reported in neonates and infants following rapid infusion of intravenous lipid emulsions. Clinoleic is administered as part of a parenteral nutrition regimen. Re-feeding of severely malnourished patients may lead to refeeding syndrome, in which intracellular shifts of potassium, phosphorus, and magnesium occur due to the onset of anabolism in such patients. Thiamine deficiency and fluid retention may also develop. These complications can be prevented by careful monitoring and slow increase of nutrient intake. Do not add any additives directly to the Clinoleic bag. If glucose and/or amino acid solutions are added to Clinoleic, the final osmolarity of the admixture must be checked before administration (see sections 6.2 and 6.6). Precipitate formation may cause vascular occlusion. Alkaline phosphatase and total bilirubin should be monitored at regular intervals during short-term or long-term intravenous nutrition, depending on the patient's clinical condition. PRECAUTIONS Do not connect bags in series to avoid air embolism from residual air in the primary bag. Air embolism may occur if residual air is not completely removed from the bag before administration and if the bag is pressurised to increase flow rate. The use of a vented intravenous set with the vent in an open position may result in air embolism. As with any parenteral nutrition, particular attention must be paid to fluid balance, especially in patients with acute oliguria or anuria and in patients with pulmonary oedema or heart failure. Severe disturbances in water and electrolyte balance, severe states of hyperhydration, and severe metabolic disorders must be corrected before starting the infusion. Fluid status should be carefully monitored in patients with pulmonary oedema and heart failure. Fat emulsions are administered simultaneously with carbohydrates and amino acids to prevent the development of metabolic acidosis. Blood glucose, triglycerides, acid-base balance, electrolytes, serum osmolarity, renal function, coagulation parameters, and blood counts should be monitored at regular intervals. Parenteral nutrition should be used with caution in patients with pre-existing liver disease or hepatic insufficiency. Liver function parameters should be carefully monitored in these patients. It is known that some patients on parenteral nutrition develop parenteral nutrition-associated liver disease (PNALD), including cholestasis, steatosis, fibrosis, and cirrhosis, which may lead to hepatic failure, as well as cholecystitis and cholelithiasis. The aetiology of these disorders is believed to be multifactorial and may differ between patients. Patients who develop abnormal laboratory parameters or signs of hepatobiliary disorders should be promptly assessed by a hepatologist to determine causality, other contributing factors, and possible therapeutic and prophylactic interventions. Use in the paediatric population Caution is required when administering Clinoleic in the presence of neonatal hyperbilirubinaemia (total serum bilirubin > 200 µmol/l). Total bilirubin levels should be carefully monitored. As with all fat emulsions, Clinoleic should be used in extremely premature infants and very low birth weight infants under careful supervision of a neonatologist. Clinical experience with the administration of Clinoleic extends to 7 days in neonates and up to 2 months in children.