Emulsion for infusions "Olimel N7E" is used for parenteral nutrition of adults and children from 2 years of age when oral or enteral nutrition is impossible, insufficient or contraindicated.
Composition
Active ingredients: alanine; arginine; aspartic acid; glutamic acid; glycine; histidine; isoleucine; leucine; lysine acetate (equivalent to lysine); methionine; phenylalanine; proline; serine; threonine; tryptophan; tyrosine; valine; sodium acetate trihydrate; potassium chloride; magnesium chloride hexahydrate; sodium glycerophosphate, hydrated; glucose, monohydrate (equivalent to anhydrous glucose); calcium chloride, dihydrate; refined olive oil; refined soybean oil.
1 three-chamber package contains:
35% glucose solution with calcium - 600 ml; 11.1% amino acid solution with electrolytes - 600 ml; 20% lipid emulsion - 300 ml.
Composition of the emulsion after mixing the contents of the 3 chambers (per 1 package):
Alanine - 9.61 g; Arginine - 6.51 g; Aspartic acid - 1.92 g; Glutamic acid - 3.32 g; Glycine - 4.60 g; Histidine - 3.97 g; Isoleucine - 3.32 g; Leucine - 4.60 g; Lysine acetate - 7.31 g, (equivalent to lysine - 5.23 g); Methionine - 3.32 g; Phenylalanine - 4.60 g; Proline - 3.97 g; Serine - 2.62 g; Threonine - 3.32 g; Tryptophan - 1.10 g; Tyrosine - 0.17 g; Valine - 4.25 g; Sodium acetate trihydrate - 2.24 g; Potassium chloride - 3.35 g; magnesium chloride hexahydrate - 1.22 g; sodium glycerophosphate, hydrated - 5.51 g; glucose monohydrate - 231.00 g (equivalent to anhydrous glucose - 210.00 g); calcium chloride, dihydrate - 0.77 g; refined olive oil and refined soybean oil - 60.00 g
Excipients: purified egg phosphatides, glycerin, sodium oleate, glacial acetic acid, hydrochloric acid, sodium hydroxide, water for injections.
Nutritional properties of the emulsion after mixing the contents of the 3 chambers:
nitrogen - 10.5 g; amino acids - 66.4 g; glucose - 210.0 g; lipids - 60 g
Energy value:
total calorie content (approximately) - 1710 kcal; non-protein calorie content (approximately) - 1440 kcal; glucose calorie content - 840 kcal; lipid calorie content (approximately) - 600 kcal; non-protein calorie content / nitrogen ratio (approximately) - 137 kcal / h; glucose / lipid calorie content ratio (approximately) - 58/42; lipid / total calorie content (approximately) - 35%.
electrolytes:
sodium - 52.5 mmol; potassium - 45.0 mmol; magnesium - 6.0 mmol; calcium - 5.3 mmol; phosphates - 22.5 mmol; acetates - 67 mmol; chlorides - 68 mmol.
pH - 6.4.
Osmolarity - 1360 mosmol / l.
Contraindication
age up to 2 years; hypersensitivity to egg, soy or peanut proteins, or to any of the active substances or excipients; congenital disorders of amino acid metabolism; severe hyperlipidemia or severe disorders of fat metabolism characterized by hypertriglyceridemia; severe hyperglycemia; pathologically elevated plasma concentrations of sodium, potassium, magnesium, calcium and / or phosphorus.
Method of application
"Olimel N7E" is contraindicated for children under 2 years of age due to inappropriate composition and volume.
The maximum daily dose given below should not be exceeded. Due to the fixed composition of the multi-chamber package, it is not always possible to provide all the nutritional needs of the patient. There may be clinical situations where the patient requires nutrients in an amount that does not correspond to the ratio in the composition of the package. In the event of any volume (dose) correction, it must be taken into account that the result will affect the dosage of all nutrients included in the preparation "Olimel N7E". For example, children may require more than 0.2 mmol / kg / day of phosphate. In such situations, healthcare professionals may adjust the volume (dose) of the preparation "Olimel N7E" to meet the increased needs.
Adults
The dosage depends on the patient's energy expenditure, clinical condition, body weight and ability to metabolize the components of the drug "Olimel N7E", as well as on the additional amount of calories or proteins entering the body orally / enterally; therefore, the package size should be selected accordingly.
The average daily needs of patients are:
from 0.16 to 0.35 g nitrogen/kg body weight (from 1 to 2 g amino acids/kg), depending on the patient's nutritional status and the degree of catabolic stress; from 20 to 40 kcal/kg; from 20 to 40 ml of fluid/kg or from 1 to 1.5 ml for each kilocalorie expended.
The maximum daily dose of "Olimel N7E" is determined by the total calorie intake - 40 kcal / kg in a volume of 35 ml / kg, which corresponds to 1.5 g / kg of amino acids, 4.9 g / kg of glucose, 1.4 g / kg of fat, 1.2 mmol / kg of sodium and 1.1 mmol / kg of potassium. For a patient with a body weight of 75 kg, this is 2450 ml of the drug "Olimel N7E" per day, which ensures that the body receives 108 g of amino acids, 343 g of glucose and 98 g of fat (for example, 2352 non-protein kcal and a total of 2793 kcal).
Typically, the rate of administration should be gradually increased over an hour, and then adjusted based on the dose administered and the daily volume consumed, as well as the duration of the infusion.
The maximum infusion rate of the drug "Olimel N7E" is 1.7 ml/kg/h, which corresponds to 0.08 g/kg/h of amino acids, 0.24 g/kg/h of glucose and 0.07 g/kg/h of fats.
Children aged 2 and over
Studies in pediatric patients have not been conducted.
The dosage depends on the patient's energy expenditure, clinical condition, body weight and ability to metabolize the components of the drug "Olimel N7E", as well as on the additional amount of calories or proteins entering the body orally / enterally; therefore, the package size should be selected accordingly.
The limiting factors for the use of the drug "Olimel N7E" in the age group from 2 to 11 years are the concentration of phosphates in the daily dose (0.2 mmol / kg / day) and the concentration of fats in the dose administered in one hour. The limiting factors for the use of the drug "Olimel N7E" in the age group from 12 to 18 years are the concentration of phosphates in the daily dose (0.2 mmol / kg / day) and the concentration of amino acids in the dose administered in one hour.
Typically, the rate of administration should be gradually increased over an hour, and then adjusted based on the dose administered and the daily volume consumed, as well as the duration of the infusion.
In general, it is recommended to start infusion in younger children with a low daily dose and gradually increase it to the maximum dosage level.
Application features
Pregnant women
There are no clinical data on the use of the drug "Olimel N7E" in pregnant women. Given the method of use and indications of the drug "Olimel N7E", if necessary, the drug can be used during pregnancy and breastfeeding.
Drivers
Studies on the effect of the drug on the ability to drive vehicles and operate other mechanisms have not been conducted.
Overdose
In case of improper use (overdose and/or exceeding the recommended rate of administration), signs of hypervolemia and acidosis may appear.
Too rapid an infusion or administration of a disproportionately large volume of the drug may cause nausea, vomiting, chills and electrolyte imbalance. In such situations, the infusion should be stopped immediately.
If the glucose infusion rate exceeds clearance, hyperglycemia, glycosuria, and hyperosmolar syndrome may develop.
Reduced or limited ability to metabolize fats can cause the development of fat overload syndrome, the results of which are usually reversible and disappear after cessation of fat infusion.
In some serious cases, hemodialysis, hemofiltration, or hemodiafiltration are indicated.
Side effects
Cardiac disorders: often (≥ 1/100 to <1/10) - tachycardia.
Metabolic and nutritional disorders: often (≥ 1/100 to <1/10) - anorexia, hypertriglyceridemia.
Gastrointestinal: often (≥ 1/100 to <1/10) - abdominal pain, diarrhea, nausea.
Vascular disorders: often (≥ 1/100 to <1/10) - arterial hypertension.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children. Do not freeze.
Shelf life - 2 years.
It is recommended to use the product immediately after opening the impermanent partitions between the 3 chambers of the package. However, after mixing the contents of the three chambers, the emulsion can be stored for 7 days at a temperature of 2 °C to 8 °C, with further storage for 48 hours at a temperature not exceeding 25 °C.
