Description
Latin name
Oliclinomel N4 -550
Release form
Emulsion for infusion.
Packaging
4 containers of 1.5 liters.
Pharmacological action of
Oliklinomel helps maintain protein and energy metabolism. The source of organic nitrogen is L-amino acids, the source of energy is dextrose and fatty acids. In addition, the mixture contains electrolytes.
The moderate content of essential fatty acids (EFAs) in the mixture increases the content of higher derivatives of EFAs in the body, making up for their deficiency.
Olive oil contains a significant amount of alpha-tocopherol, which, combined with a small amount of PUFA, increases the body’s vitamin E content and reduces lipid peroxidation.
Pharmacokinetics
The ingredients of the emulsion for infusion (amino acids, electrolytes, dextrose, lipids) are metabolized and excreted in the same way as when they are administered separately.
The pharmacokinetic properties of the amino acids administered iv are generally the same as those of the enteral diet (however, in this case, the amino acids obtained from dietary proteins pass through the liver before entering the systemic circulation).
The rate of elimination of lipid emulsion particles depends on their size. Small lipid particles are excreted more slowly, however, they are faster cleaved by lipoprotein lipase.
The particle size of the lipid emulsion in the Oliklinomel mixture is close to the size of the chylomicron, so they have a similar elimination rate.
Indications
For parenteral nutrition in adults and children over 2 years of age, in cases where enteral nutrition is impossible, insufficient or contraindicated.
Contraindications
Hypersensitivity to the drug, severe renal failure in the absence of hemodialysis or hemofiltration, severe liver failure, severe coagulation disorders, severe hyperlipidemia, hyperglycemia, lactic acidosis, congenital disorders of amino acid metabolism, disturbances in electrolyte metabolism, increased plasma concentration of one of the electrolytes included in the mixture, pulmonary edema, hyperhydration, decompensated heart failure and hypotonic hydration, unstable conditions (severe post-traumatic conditions, decompensated diabetes mellitus, acute phase of hypovolemic shock, acute phase of myocardial infarction, t zhely metabolic acidosis, severe sepsis, hyperosmolar coma), children’s age (up to 2 years)
Precautions: patients with increased plasma osmolarity, adrenal insufficiency, heart failure and pulmonary pathology.
Special instructions
Method of administration of the drug.
1. Open the package:
break the protective shell
after opening the shell discard the container with oxygen-absorbing substance (if any)
make sure that the container and the partitions between the
sections are intact only if the container is not damaged and the integrity is not broken partitions between sections (i.e. the contents of 3 sections were not mixed) while the solutions of amino acids and dextrose should be transparent, and the emulsion is homogeneous.
2. Mixing solutions and emulsions:
make sure that the product has an ambient temperature at the time of the destruction of the partitions between the
sections by manually turning the top of the container (for which it is suspended) around its axis.
septa will disappear from the future inlet. Continue twisting the top until the partitions open for at least half their length. Stir by turning the container (at least 3 times).
3. Preparation for infusion:
aseptic conditions must be observed
hang container
remove the plastic fuse from the future outlet
attach the infusion system to this place.
4. Concurrent administration of other nutrients:
any additional nutrients (including vitamins) can be added to the finished mixture
vitamins can also be added to the section with dextrose solution before the contents of the sections are mixed.
Oliklinomel can be supplemented with the following components:
electrolytes: the stability of the emulsion was maintained when adding no more than 150 mmol of sodium, 150 mmol of potassium, 5.6 mmol of magnesium, 5 mmol of calcium per 1 liter of the finished mixture
organic phosphates: the stability of the emulsion was maintained when adding up to 15 mmol /
package trace elements and vitamins: the stability of the emulsion was maintained with the addition of doses not exceeding the daily allowance.
The addition of micronutrients should be done under aseptic conditions by injection of micronutrients into the container (via an injection needle):
prepare the puncture site
puncture the container at this point and inject the
micronutrient solution mix the added substances with the contents of the packet.
5. Rules for the administration of the drug:
if oliklinomel was stored at a low temperature, before using it, make sure that the drug is warmed to room temperature
should be administered only after the integrity of the partitions between 3 sections is broken and their contents are mixed.
The drug should not be injected into the peripheral vein.
Correction of disturbances in water and electrolyte balance, as well as metabolic disturbances, must be carried out before the start of infusion.
When vitamins and minerals are added, prior to the infusion, it is necessary to determine the doses of these substances (depending on the need for them) and calculate the osmolarity of the resulting solution.
Use the drug only if the container is not damaged and the integrity of the partitions between the sections is not broken (i.e. the contents of the 3 sections were not mixed), while the solutions of amino acids and glucose should be transparent, and the emulsion should be homogeneous.
The drug should be used immediately after opening the container and should not be stored for the next infusion.
Throughout the course of treatment, monitoring of water and electrolyte balance, plasma osmolarity, acid-base balance, blood glucose and liver function tests are required. Plasma triglyceride concentrations and the ability to remove lipids from the blood should be regularly evaluated. The concentration of serum triglycerides during infusion should not exceed 3 mmol / L. Their concentration should be measured no earlier than 3 hours after the start of the infusion.
If you suspect a lipid metabolism disorder, it is recommended that you repeat the same tests 5-6 hours after stopping the administration of the emulsion. In adults, lipid elimination should take place less than 6 hours after the cessation of lipid emulsion infusion. The next infusion should be carried out only after normalization of the concentration of triglycerides in blood plasma.
Regular clinical examination should be performed in the following cases: in case of liver failure – because of the risk of the appearance or intensification of neurological disorders, associated with hyperammonemia in renal failure (especially in the presence of hyperkalemia) risk of occurrence or intensification of metabolic acidosis and hyperazotemia in the absence of the ability to carry out hemofiltration or dialysis in diabetes mellitus – control glucose, glucosuria, ketonuria and, if possible, adjust the dose of insulin in case of blood coagulation disorder hyperlipidemia anemia. With prolonged use (for several weeks), blood tests and coagulation factors should be closely monitored.
When used in pediatrics, you should focus on the age of the child, protein and energy requirements, as well as on the disease. If necessary, enteral proteins and / or energy components (carbohydrates, lipids) should be added.
For parenteral nutrition in children older than 2 years, it is advisable to choose the volume of the container corresponding to the daily dose. The addition of vitamins and minerals is carried out in doses used in pediatrics.
Ingredients Active ingredients: olive oil and soybean oil mixture L-alanine L-arginine L-glycine L-histidine L-isoleucine L-leucine L-lysine L-methionine L-phenylalanine L-proline L-serine L-threonine L-tryptophan L-tyrosine L- valine sodium acetate sodium trihydrate glycerophosphate potassium pentahydrate magnesium chloride chloride hexahydrate dextrose anhydrous calcium chloride dihydrate
Excipients: purified egg lecithin sodium glycerol sodium oleate hydroxide acetic acid hydrochloric acid water for injection.
Dosage and Administration
Intravenously through a central vein. The dose of the drug and the duration of the appointment are determined by the need for parenteral nutrition and the condition of each individual patient.
Adults. The average need for organic nitrogen is 0.16 0.35 g / kg / day (approximately 1 2 g of amino acids / kg / day). Energy requirements averaged 25 40 kcal / kg / day.
The maximum daily dose is 36 ml / kg body weight, which is equivalent to 1.44 g of amino acids, 5.76 g of dextrose, 1.44 g of lipids per kg of body weight, i.e. 2520 ml of emulsion for a patient weighing 70 kg.
Children over 2 years old. The average need for organic nitrogen is 0.35 0.45 g / kg / day (approximately 2-3 g of amino acids / kg / day). Energy requirements average 60 110 kcal / kg / day. The dose depends on the amount of fluid ingested and daily protein requirements. In this case, the state of water metabolism should be taken into account.
The maximum daily dose is 75 ml / kg body weight, which is equivalent to 3 g of amino acids, 12 g of dextrose and 3 g of lipids per kg of body weight. This daily dose should not be exceeded, except in special cases.
Maximum infusion rate not more than 1.5 ml / kg / h, i.e. not more than 0.06 g of amino acids, 0.24 g of dextrose and 0.06 g of lipids per 1 kg of body weight per hour.
Drug Interactions
Do not administer the drug in parallel with blood products through the same catheter due to the possibility of pseudoagglutination.
Overdose
Symptoms: hypervolemia, acidosis, nausea, vomiting, shivering, electrolyte imbalance. When too high doses of dextrose are administered – hyperglycemia, glucosuria, hyperosmolar syndrome. The development of fat overload syndrome is possible.
Treatment: The infusion should be stopped. In severe cases – hemodialysis, hemofiltration or hemodiafiltration.
Storage conditions
At 2 25 ° C (do not freeze).
shelf life
2 years
Deystvuyushtee substance
Aminokislot dlya parenteralynogo queries
dosage form
infusion solution
Possible product names
Oliklinomel N4-550 E three-chamber containers 1.5 l, 4 pcs.
OLYCLINOMEL N4-550E 1, 5 L N4 CONTAINER
Oliklinomel N4-550E 1,5 l No. 4 container
