Index of drugs

Parenteral nutrition of adults and children over the age of 2 years, when oral or intestinal nutrition is impossible, insufficient or contraindicated.

1 bag 2000 ml ready to use emulsion for infusion contains: 800 ml of Glucose solution - 242 g of glucose monohydrate (equivalent to 220 g of anhydrous glucose), 1.03 of Calcium chloride dihydrate; 400 ml of fat emulsion - 80 g soya oil and olive oil; 800 ml of amino acid solution - 5.69 g of isoleucine, 7.9 g of leucine, 8.96 g of lysine, 5.69 g of methionine, 7.9 g of phenylalanine, 5.69 g of threonine, 1.9 g of tryptophan, 7.29 g of g of valine, 11.16 g of arginine, 6.79 g of histidine, 16.48 g of alanine, 3.3 g of aspartic acid, 5.69 g of glutamic acid, 7.9 g of Glycine, 6.79 g of proline, 4.5 g serine, 0.3 g tyrosine, 4.47 g potassium chloride, 2.99 g sodium acetate trihydrate, 1.62 g Magnesium chloride hexahydrate, 7.34 hydrated sodium glycerophosphate. Energy value: 2140 kcal. Osmolarity: 1310 mOsmol / kg. pH 6.4.Total content in 2000 ml - 113.9 g amino acids, 18 g nitrogen, 220 g Glucose, 80 g fats and electrolytes: 70 mmol sodium, 60 mmol potassium, 8 mmol Magnesium, 7 mmol Calcium, 107 mmol acetate, 90 mmol chloride, 30 mmol phosphates.

A preparation for parenteral nutrition containing amino acids, carbohydrates, electrolytes and fatty acids.

Hypersensitivity to egg white, soy, peanut or any of the active or auxiliary substances of the drug. Congenital disorders of amino acid metabolism. Severe hyperlipidemia or severe disorders of fat metabolism with the occurrence of hypertriglyceridemia. Severe hyperglycemia. Pathologically elevated serum levels of sodium, potassium, magnesium, calcium and / or phosphorus. Do not use in premature babies, newborns and children under the age of 2 years.

The drug should not be administered to the peripheral vein. Too quick administration of solutions for total parenteral nutrition may result in serious or fatal complications. If any signs or symptoms of an allergic reaction (such as sweating, fever, chills, headache, skin rash or shortness of breath) are worsening, the infusion should be stopped immediately. Before starting the infusion, severe water and electrolyte imbalance, severe fluid overload and severe metabolic disturbances should be corrected. Patients requiring parenteral nutrition are often predisposed to infectious complications due to malnutrition and / or the condition of the underlying disease. The occurrence of septic complications can be reduced by increasing the pressure on the use of aseptic techniques during the placement and maintenance of the catheter and during preparation of the preparation for feeding. Careful monitoring of signs, symptoms and laboratory tests to detect fever / chills, leukocytosis, technical complications associated with venous access equipment and hyperglycaemia may help in early diagnosis of infection. Water and electrolyte management, serum osmolarity, serum triglycerides, acid-base balance, blood glucose, liver and kidney function, coagulation tests and blood cell counts, including platelet counts, should be performed throughout the treatment period. If liver disease is suspected, monitoring of serum ammonia should be considered. If nutrition is not adapted to the patient's needs or the metabolic capacity of any of the nutritional components is not accurately evaluated, metabolic abnormalities may occur. Administration of an amino acid solution may lead to severe folate deficiency, therefore the daily administration of folic acid is recommended. Caution should be exercised in patients with hepatic impairment (risk of developing or exacerbating neurological disorders related to hyperammonaemia, regular clinical and laboratory tests, in particular blood glucose, electrolyte and triglyceride determination), in patients with renal insufficiency, especially if hyperkalemia (risk of developing or exacerbating metabolic acidosis and hyperazotemia,if there is no additional removal of renal excretion products of metabolism; fluids and electrolytes and triglycerides should be carefully monitored), in patients with coagulation disorders and anemia (blood count and clotting parameters should be carefully monitored), in patients with increased osmolarity, in patients with adrenal insufficiency, in patients with heart failure or lung and in patients in the following circumstances: metabolic acidosis (administration of bicarbonate for lactic acidosis is not recommended, clinical and laboratory tests should be carried out regularly), diabetes (blood glucose monitoring, glucosuria, ketonuria should be monitored and adjusted insulin dosage if necessary), Hyperlipidemia caused by the presence of lipids in the emulsion for infusion (regular clinical and laboratory tests should be carried out) and disturbances of amino acid metabolism. Serum triglycerides and the body's ability to excrete fats should be checked regularly. The concentration of triglycerides in the serum during infusion may not exceed 3 mmol / l. In suspecting anomalies in fat metabolism, daily serum triglyceride measurements should be made, with a break of 5 to 6 hours after the last administration of fats. In adults, the serum must be clear in less than 6 hours after the infusion containing the fat emulsion has been discontinued. The Next infusion can only be given when serum triglyceride levels return to baseline. If hyperglycaemia occurs, adjust the infusion rate and / or give insulin. The amount of trace elements and Vitamins is insufficient to cover the body's needs; they should be provided with adequate supplementation to avoid shortages. In the case of malnourished patients, the introduction of parenteral nutrition may cause fluid displacement, resulting in pulmonary edema and congestive heart failure, as well as a decrease in serum concentration of potassium, phosphorus, magnesium or water-soluble vitamins. These changes may occur within 24 to 48 h, therefore, careful and slow introduction of parenteral nutrition, together with close monitoring and proper adjustment of fluids, electrolytes, trace elements and vitamins is recommended. In the case of administration to children over 2 years of age, it is important to use a bag with a volume corresponding to the daily dose. In children over the age of 2, the amount of phosphates limits the daily intake, therefore, the drug should be supplemented with macro-nutrients and calcium, as well as vitamins and trace elements in the composition and quantities of pediatric. The drug should be administered with caution to patients with a tendency to stop electrolytes. Intravenous infusion of amino acids is accompanied by increased urinary excretion of trace elements, in particular copper and zinc, which should be taken into account when dosing trace elements, especially with long-term intravenous feeding. The addition of excessive amounts of calcium and phosphorus may precipitate the calcium phosphate precipitate. The formation of such deposits or destabilization of fat emulsion may cause occlusion of the vessels. The drug contains soybean oil and egg phosphatides that can cause hypersensitivity reactions.

There are no clinical data on the use of the drug in pregnant or breast-feeding women. Considering the use and indication, if necessary, it may be considered to administer the drug during pregnancy and during breastfeeding.

Side effects often observed in patients who are in a different clinical condition (ie post-operative fasting, severe malnutrition, insufficient intestinal absorption or a ban on enteral feeding): tachycardia, anorexia, hypertriglyceridaemia, abdominal pain, diarrhea, nausea, hypertension. Other sources describe: very rarely - fat overload syndrome (symptoms: hyperlipidemia, fever, hepatic steatosis, hepatomegaly, anemia, decreased white blood cell count, decreased platelet count, blood coagulation disorders and coma, requiring hospitalization); frequency unknown - thrombocytopenia, hepatomegaly, jaundice, hypersensitivity, increase in alkaline phosphatase, transaminase and bilirubin in the blood, azotemia.

Intravenously. Individual dosage depending on the clinical condition of the patient.Adults: the maximum dose is 35 ml / kg / day, corresponding to 2 g amino acids / kg / day, 3.9 g glucose / kg / day, 1.4 g fat / kg / day, 1.2 mmol / sodu / kg / day and 1.1 mmol potassium / kg / day; maximum infusion rate of 1.8 ml / kg / h. Children: the maximum daily dose is 13 ml / kg / day, which corresponds to 0.8 g of amino acids / kg / day, 1.5 g of glucose / kg / day, 0.5 g of fat / kg. / day. Children 12-18 years: maximum infusion rate 2.1 ml / kg / h. According to the Safety Announcement of 05/02/2014 and the ESPGHAN / ESPEN guidelines of 2005, in children aged 2-11, the maximum lipid infusion rate was reduced to 0.13 g / kg / h - maximum infusion rate 3.3 ml / kg m / h. In small children, it is recommended to start the infusion in small doses (ie 12.5-25 ml / kg) and increase gradually to the maximum dose.
The drug is given by infusion (duration 12-24 h) to the central veins. The gradual increase of the infusion rate during the first hour until the planned speed is achieved prevents possible complications.