Index of drugs

Parenteral nutrition for adults and children over the age of 2 years in cases where oral or enteral nutrition is impossible, inadequate or contraindicated.

The preparation is delivered as a three-chamber bag - 20% Glucose solution (400 ml), 5.5% amino acid solution (400 ml), 10% fat emulsion (200 ml). The amino acid chamber contains: 4.56 g alanine, 2.53 g arginine, 2.27 Glycine, 1.06 g histidine, 1.32 g isoleucine, 1.61 g leucine, 1.6 g lysine hydrochloride (corresponding to 1 , 28 g lysine), 0.88 g methionine, 1.23 g phenylalanine, 1.5 g proline, 1.1 g serine, 0.92 g threonine, 0.4 g tryptophan, 0.09 g tyrosine, 1, 28 g valine, 0.98 g sodium acetate trihydrate, 2.14 g sodium glycerophosphate pentane, 1.19 g potassium chloride, 0.45 g Magnesium chloride hexahydrate. The glucose chamber contains 88 g of glucose monohydrate (equivalent to 80 g of anhydrous glucose) and 0.3 g of Calcium chloride dihydrate. The lipid chamber contains 20 g of purified olive oil (about 80%) and purified soybean oil (about 20%). Energy value: 610 kcal. Osmolarity: 750 mOsmol / l.

Preparation for parenteral nutrition containing nitrogen (15 L-amino acids, including 8 essential) and energy components - glucose and essential fatty acids. Nitrogen and energy are essential for the proper functioning of all cells of the body and are important for protein synthesis, growth, wound healing, immune system function, muscles and many other cellular activities. The product also contains electrolytes.

Hypersensitivity to egg white, soy, peanut or any of the active substance or auxiliary drug. Congenital metabolic defects in 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). Premature babies, infants and children under the age of 2, because the ratio of energy value to nitrogen content and the amount of energy supplied are inadequate.

Caution should be exercised in patients with increased osmolarity, adrenal insufficiency, heart failure or lung disorders, hepatic insufficiency (risk of developing or exacerbating neurological disorders related to hyperammonaemia, regular testing, in particular Glucose, electrolytes and triglycerides in the blood), renal insufficiency , especially in cases of hyperkalemia (risk of developing or exacerbating metabolic acidosis and hypererotism, fluid status, electrolytes and triglycerides monitoring), coagulation disorders and anemia (blood counts and coagulation parameters should be monitored), metabolic acidosis (administration of bicarbonates is not recommended; clinical and laboratory tests should be carried out regularly), diabetes (blood glucose monitoring in urine, ketonuria should be monitored and adjusted insulin dosage if necessary) , hyperlipidemia (clinical and laboratory tests should be carried out regularly) and disturbances of amino acid metabolism. During the use of the preparation an additional supply of Vitamins and trace elements is necessary. Before starting the infusion, severe water and electrolyte disturbances, severe fluid overload conditions and severe metabolic disorders should be corrected. The water-electrolyte balance, serum osmolarity, serum triglycerides (measured no earlier than after 3 hours of continuous infusion), acid-base balance, blood glucose, liver and kidney function tests, coagulation tests should be monitored throughout the treatment period. and the number of blood cells, including platelets, and control the body's ability to remove fats. If the amount of nutrients taken is not adjusted to the patient's needs or the metabolic capacity of any of the nutrients is not accurately evaluated, metabolic abnormalities may occur.In case of suspected abnormalities in fat metabolism, it is recommended to perform daily serum triglyceride measurements after 5-6 h without fat administration. The Next infusion can only be started when serum triglyceride levels return to normal. Supplementing nutrients in severely malnourished patients may result in a set of symptoms associated with it, which is characterized by the transfer of potassium, phosphorus and magnesium to the intercellular space. It may also lead to thiamine deficiency and fluid retention in the body. Accurate control and a slow increase in the supply of nutrients, avoiding overfeeding can prevent these complications. Patients requiring parenteral nutrition are often predisposed to infectious complications due to malnutrition and / or condition associated with underlying disease. 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. In case of symptoms or signs of an allergic reaction (eg sweating, fever, chills, headache, skin rash or shortness of breath) the infusion should be stopped immediately.

When recommending the administration of emulsions to pregnant and breastfeeding women, potential benefits and risks should always be considered. There is currently insufficient clinical data to assess the tolerance of the ingredients in pregnant or breast-feeding women.

Common: hypersensitivity, headache, diarrhea, azotemia, chills, petechiae, pain, swelling, blisters at the infusion site, increased liver enzymes, increased γ-glutamyltransferase activity, increased triglycerides in the blood, increased alkaline phosphatase in the blood. Frequency unknown: tremor, abdominal pain, vomiting, nausea, cholestatic jaundice, cholestasis, jaundice, erythema, hyperhidrosis, musculoskeletal pain, back pain, chest pain, limb pain, muscle cramps, phlebitis at the catheter site , injection site swelling, local edema, peripheral edema, fever, feeling hot, elevated body temperature, malaise, inflammation, increased bilirubin in the blood, increased blood glucose, hyperglycemia. Fat overload syndrome has been reported with similar formulations. In children receiving fat in the form of an infusion, cases of thrombocytopenia have been reported.

Intravenously. Dosage depends on the energy expenditure, body weight, age and clinical status of the patient, the ability to metabolize the components of the preparation and additional energy ingredients or proteins administered orally / enterally. Adults: the maximum daily dose is 40 ml / kg. corresponding to 0.88 g of amino acids, 3.2 g of glucose, 0.8 g of fats, 0.84 mmol of sodium, 0.64 mmol of potassium / kg. i.e. 2,800 ml of emulsion for a patient weighing 70 kg. Children> 2 years: the maximum daily dose is 100 ml / kg. corresponding to 2.2 g of amino acids, 8 g of glucose, 2 g of fats, 2.1 mmol of sodium, 1.6 mmol of potassium / kg. Do not exceed a dose of 3 g amino acids / kg / day and / or 17 g glucose / kg / day and / or 3 g fat / kg / day, except in special cases.
The product should be administered intravenously through a central or peripheral vein. The recommended duration of the infusion is 12-24 h. The infusion rate should be increased gradually during the first hour of administration. Do not exceed the infusion rate of 3 ml / kg / h, ie 0.06 g of amino acids, 0.24 g of glucose and 0.06 g of fat / kg / h. When introducing additional ingredients, the final osmolarity of the mixture must be measured before administration.