Nutriflex Lipid Special parenteral nutrition solutions are used to provide energy, essential fatty acids, amino acids, electrolytes, and fluid during parenteral nutrition of patients with moderate to severe catabolism, when oral or enteral nutrition is impossible, insufficient, or contraindicated.
Composition
The ready-to-use emulsion after mixing the contents of the chambers contains (active ingredients):
from the upper left chamber (glucose solution): glucose, monohydrate - 198 g, equivalent to anhydrous glucose - 180 g. sodium dihydrogen phosphate, dihydrate - 3.12 g; zinc acetate, dihydrate - 8.78 mg; from the upper right chamber (lipid emulsion): soybean oil, refined - 25 g; medium chain triglycerides - 25 g; from the lower chamber (amino acid solution): isoleucine - 4.11 g; leucine - 5.48 g; lysine hydrochloride - 4.98 g, equivalent to lysine - 3.98 g; methionine - 3.42 g; phenylalanine - 6.15 g; threonine - 3.18 g; tryptophan - 1 g; valine - 4.51 g; arginine - 4.73 g; histidine hydrochloride, monohydrate - 2.96 g, equivalent to histidine - 2.19 g; alanine - 8.49 g; aspartic acid - 2.63 g; glutamic acid - 6.14 g; glycine - 2.89 g; proline - 5.95 g; serine - 5.25 g; sodium hydroxide - 1.464 g; sodium chloride - 0.473 g; sodium acetate, trihydrate - 0.313 g; potassium acetate - 4.611 g; magnesium acetate, tetrahydrate - 1.137 g; calcium chloride, dihydrate - 0.779 g
electrolytes:
sodium - 67 mmol; potassium - 47 mmol; magnesium - 5.3 mmol; calcium - 5.3 mmol; zinc - 0.04 mmol; chlorides - 60 mmol; acetates - 60 mmol; phosphates - 20 mmol.
Amino acids - 71.8 g
Nitrogen - 10 m
Carbohydrates - 180 g.
Lipids - 50 g.
Energy in the form of lipids - 1990 kJ (475 kcal).
Energy in the form of hydrocarbons - 3015 kJ (720 kcal).
Energy in the form of amino acids - 1170 kJ (280 kcal).
Non-protein energy - 5005 kJ (+1195 kcal).
Total energy - 6175 kJ (1475 kcal).
Osmolality - 2090 mOsm / kg.
PH - 5.0-6.0.
Contraindication
Hypersensitivity to egg or soy proteins, peanut butter or any component; congenital abnormalities of amino acid metabolism; lipid metabolism disorders; high serum electrolyte values; unstable metabolic situation (e.g. severe post-acute syndrome, decompensated diabetes mellitus, metabolic acidosis, coma of unknown origin); hyperglycemia that does not respond to insulin doses up to 6 units of insulin / h; intrahepatic cholestasis; severe liver failure; severe renal failure in the absence of renal replacement therapy; hemorrhagic diathesis during exacerbation; acute phase of myocardial infarction and stroke; acute thromboembolic events, lipid embolism; severe hypertriglyceridemia (≥ 1000 mg / dl or 11.4 mmol / l); severe coagulopathy; acidosis.
"Nutriflex Lipid Special" should not be used in newborns, infants, and children under 2 years of age due to its composition.
General contraindications to parenteral nutrition:
unstable circulatory state with a threat to life (state of collapse or shock); insufficient supply of cells with oxygen; state of hyperhydration; disorders of electrolyte and fluid balance; acute pulmonary edema; decompensated heart failure.
Method of application
Dosage should be adjusted according to the patient's individual needs.
"Nutriflex Lipid Special" is recommended to be administered by continuous intravenous infusion. Gradual increase in infusion rate to the desired level during the first 30 minutes of administration helps to avoid possible complications.
Children aged 15 and over and adults
The maximum daily dose is 35 ml/kg body weight, which corresponds to:
2 g amino acids / kg body weight per day; 5.04 g glucose / kg body weight per day; 1.4 g lipids / kg body weight per day.
The maximum infusion rate is 1.7 ml/kg body weight per hour, which corresponds to:
0.1 g amino acids / kg body weight per hour; 0.24 g glucose / kg body weight per hour; 0.07 g lipids / kg body weight per hour.
For a patient weighing 70 kg, this corresponds to an infusion rate of 119 ml per hour. The amount of substrate administered is therefore 6.8 g of amino acids per hour, 17.1 g of glucose per hour and 4.8 g of lipids per hour.
In general, it is recommended that the maximum daily energy supply does not exceed 40 kcal/kg body weight per day. If there are special indications, for example in burn patients, a higher dose may be administered.
Children aged 2 to 14 years
The dosage recommendations given are based on average requirements. Dosage should be individualized according to age, stage of development, and type of disease. The child's hydration status should be taken into account when calculating the dose.
Children may need to start therapeutic nutrition at half the target dose. The dose should be increased gradually, according to the patient's individual metabolic capacity, until the maximum dose is reached.
The daily dose for children 2-5 years old is 25 ml/kg of body weight, which corresponds to:
1.43 g amino acids / kg body weight per day; 3.6 g glucose / kg body weight per day; 1 g lipids / kg body weight per day.
The daily dose for children 6-14 years old is 17.5 ml/kg of body weight, which corresponds to:
1 g amino acids / kg body weight per day; 2.52 g glucose / kg body weight per day; 0.7 g lipids / kg body weight per day.
Depending on the individual requirements of children, "Nutriflex Lipid Special" may not sufficiently meet the total energy needs. In such cases, depending on the situation, it is necessary to additionally introduce carbohydrates and/or lipids.
Duration of use
The duration of treatment according to the above indicators is limited. With prolonged use of the drug "Nutriflex Lipid Special", the patient must be administered a sufficient amount of trace elements and vitamins.
Infusion duration for one bag. The recommended infusion duration for parenteral nutrition is a maximum of 24 hours.
Method of administration
Intravenous administration. For central venous infusion only.
It is always a good idea to bring the emulsion to room temperature before infusion.
Preparation of mixed emulsion:
Remove the inner bag from the protective outer bag. Place the bag on a hard surface. Open the sealed seam separating the upper and lower chambers by pressing with both hands. Quickly mix the contents of the bag chambers.
Preparation for infusion:
Bend both empty chambers of the bag back. Hang the bag on an infusion stand using the central hanging loop. Remove the protective cap from the administration port and administer the infusion using standard technique.
Application features
Pregnant women
There are no clinical data available on the effects of the drug "Nutriflex Lipid Special" on pregnancy. Preclinical studies of the effects on pregnancy, embryonic/fetal development, childbirth and/or postnatal development have not been conducted. Before using the drug in pregnant women, the doctor should consider the benefit/risk ratio.
Breastfeeding is not recommended during the period when a woman requires parenteral nutrition.
Drivers
Since the drug is intended for use in an intensive care unit setting, its effect on reaction rate has not been sufficiently studied.
Overdose
With the recommended regimen, an overdose of the drug "Nutriflex Lipid Special" should not be expected.
Symptoms of fluid and electrolyte overdose: hypertonic hyperhydration, electrolyte imbalance and pulmonary edema.
Symptoms of amino acid overdose: renal loss of amino acids with subsequent amino acid imbalance, vomiting and tremors.
Symptoms of glucose overdose: hyperglycemia, glycosuria, dehydration, hyperosmolarity, hyperglycemic-hyperosmolar coma.
Symptoms of lipid overdose: Lipid overdose can lead to fat overload syndrome.
Treatment
In case of overdose, immediate interruption of the infusion is indicated. Further therapeutic measures depend on the specific symptoms and their severity. If repeated infusion is necessary after the symptoms have resolved, it is recommended to gradually increase its rate, monitoring at short intervals. During the infusion, the plasma triglyceride concentration should not increase to a value of more than 3 mmol / l.
Side effects
Gastrointestinal: infrequently (≥ 1/1000 to <1/100) - nausea, vomiting, loss of appetite.
Storage conditions
Store at a temperature not exceeding 25 °C, protected from light and out of the reach of children. Do not freeze.
If the contents of the bag accidentally freeze, the product should be discarded.
The shelf life of an unopened container is 2 years.
After opening the container, the emulsion should be administered immediately.
After mixing the contents of the chambers: the emulsion can be stored at 2-8°C for 4 days and for another 48 hours at 25°C.
