Oliclinomel N4-550 E, triple chamber containers 1.5 l, 4pcs

Composition

Active ingredients:

olive and soy bean oils blend;

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 trihydrate;

sodium glycerophosphate pentahydrate;

potassium chloride;

magnesium chloride hexahydrate;

dextrose anhydrous;

calcium chloride dihydrate;

Auxiliary substances:

purified egg lecithin;

glycerol;

sodium oleate;

sodium hydroxide;

acetic acid;

hydrochloric acid;

water for injection.

Pharmacological action

Olyclinomel helps maintain protein and energy metabolism. The source of organic nitrogen is L-amino acids, and the source of energy is dextrose and fatty acids. In addition, the mixture contains electrolytes.

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 infusion emulsion (amino acids, electrolytes, dextrose, lipids) are metabolized and eliminated from the body in the same way as when they are administered separately.

The pharmacokinetic properties of intravenous amino acids generally coincide with those of enteric nutrition (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 removed more slowly, while they are broken down faster by lipoprotein lipase. The particle sizes of the lipid emulsion in the Olyclinomel mixture approach the chylomicron size, so they have a similar elimination rate.

Indications

For parenteral nutrition of adults and children over 2 years of age, in cases where enteral nutrition is impossible, insufficient or contraindicated.

Contraindications

Hypersensitivity to the components of the drug, severe renal failure in the absence of hemodialysis or hemofiltration, severe liver failure, severe blood clotting disorders, severe hyperlipidemia, hyperglycemia, lactic acidosis, congenital disorders of amino acid metabolism, electrolyte metabolism disorders, 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, severe metabolic acidosis, severe sepsis, hyperosmolar coma), children (up to 2 years)

With caution:  patients with increased plasma osmolarity, adrenal insufficiency, heart failure and pulmonary pathology.

Side effects

Hyperthermia, sweating, tremor, nausea, headache, respiratory disorders; sometimes-a temporary increase in the concentration of such biochemical markers of liver function as alkaline phosphatase, transaminase, bilirubin, especially with prolonged use for several weeks.

Rarely-hepatomegaly, jaundice; severe allergic reaction to soybean oil; in children — thrombocytopenia.

If you experience symptoms of an allergic reaction (fever, tremor, skin rash, respiratory disorders), the infusion should be stopped immediately.

Due to the reduced ability to eliminate lipids from the blood, it is possible to develop a fat overload syndrome characterized by hyperlipidemia, fever, fatty liver infiltration, hepatomegaly, anemia, leukopenia, thrombocytopenia, coagulation disorders and coma. These symptoms are reversible when the infusion of the emulsion is suspended.

Interaction

Do not administer the drug in parallel with blood products through the same catheter due to the possibility of pseudoagglutination.

How to take, course of use and dosage

Intravenously, through the central vein. The dose of the drug and the duration of use are determined by the need for parenteral nutrition and the condition of each individual patient.

For adults. The average demand for organic nitrogen is 0.16-0.35 g / kg / day (approximately 1-2 g of amino acids/kg / day). The average energy requirements are 25-40 kcal / kg / day.

The maximum daily dose is 36 ml / kg of 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 demand for organic nitrogen is 0.35-0.45 g / kg / day (approximately 2-3 g of amino acids/kg / day). The average energy requirements are 60-110 kcal / kg / day. The dose depends on the amount of fluid that has entered the body and the daily protein requirement. In this case, the state of water metabolism should be taken into account.

The maximum daily dose is 75 ml / kg of 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.

The maximum infusion rate is no more than 1.5 ml / kg / h, i. e. no 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.

Overdose

Symptoms:  hypervolemia, acidosis, nausea, vomiting, trembling, electrolyte imbalance. If too large doses of dextrose are administered, hyperglycemia, glucosuria, hyperosmolar syndrome can occur. Possible development of fat overload syndrome.

Treatment:  the infusion should be stopped. In severe cases-hemodialysis, hemofiltration or hemodiafiltration.

Special instructions

Method of application of the drug.

1. Open the package:

• tear the protective shell;
• after opening the wrapper to throw away the container with the substance, absorbing oxygen (if any);
• to ensure the integrity of the container and the partitions between the sections;
• use only if the container is not damaged or broken the integrity of the bulkheads between sections (i. e., the contents of 3 sections was not mixed) with 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 the ambient temperature at the time of destruction of the partitions between the sections;
• manually turn the top of the container (for which it is suspended) around its axis.
• partitions will disappear from the side of the future entrance opening. Continue to twist the top until the partitions open for at least half of their length. Stir by turning the container over (at least 3 times).

3. Preparation for infusion:

• aseptic conditions must be met;
• hang the container;
• remove the plastic guard from the future outlet;
• attach the infusion system to this place.

4. Simultaneous use 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.

Olyclinomel can be supplemented with the following components:

• electrolytes:  the stability of the emulsion was maintained with the addition of 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 with the addition of up to 15 mmol/bag;
• trace elements and vitamins:  the stability of the emulsion was maintained with the addition of doses not exceeding daily values.

Micronutrient supplementation should be performed under aseptic conditions by injecting the micronutrients into a container (via an injection needle). :

• prepare the puncture site;
• puncture the container in this place and introduce a solution of micronutrients;
• mix the added substances with the contents of the package.

5. Rules for drug use:

• if Olyclinomel has been stored at a low temperature, make sure that the preparation is heated to room temperature before using it;
• the drug should be administered only after the integrity of the partitions between the 3 sections is broken and their contents are mixed.

The drug should not be injected into a peripheral vein.

Correction of water and electrolyte balance disorders, as well as metabolic disorders, should be carried out before the infusion.

When adding vitamins and trace elements, the dose of these substances should be determined before the infusion (depending on the need for them) and the osmolarity of the resulting solution should be calculated.

Use the preparation only if the container is not damaged and the integrity of the partitions between the sections is not broken (i. e. the contents of 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.

During the entire course of treatment, monitoring of water and electrolyte balance, plasma osmolarity, acid-base balance, blood glucose and liver function tests is necessary. Plasma triglyceride concentrations and the ability to remove lipids from the blood should be evaluated regularly. The concentration of serum triglycerides during the infusion should not exceed 3 mmol/l. Their concentration should be measured no earlier than 3 hours after the start of the infusion.

If lipid metabolism disorders are suspected, it is recommended to repeat the same tests 5-6 hours after stopping the emulsion use. In adults, lipid elimination should occur less than 6 hours after discontinuation of the lipid emulsion infusion. The next infusion should be performed only after normalization of the concentration of triglycerides in the blood plasma.

A regular clinical examination should be performed in the following cases:: in hepatic insufficiency — due to the risk of occurrence or increase of neurological disorders associated with hyperammonemia; in renal insufficiency (especially in the presence of hyperkalemia); the risk of occurrence or increase of metabolic acidosis and hyperazotemia in the absence of the possibility of hemofiltration or dialysis; in diabetes mellitus – control of glucose concentration, glucosuria, ketonuria and, if possible, correction of the dose of insulin; in blood clotting disorders; anemia; hyperlipidemia. With prolonged use (for several weeks), blood tests and clotting factors should be monitored more closely.

When used in pediatrics, you should focus on the child’s age, protein and energy requirements, as well as the disease. If necessary, enteral proteins and/or energy components (carbohydrates, lipids) should be added.

For parenteral nutrition of children over 2 years of age, it is advisable to choose the volume of the container corresponding to the daily dose. The addition of vitamins and trace elements is carried out in the doses used in pediatrics.

Product form

emulsion for infusions

Storage conditions

At a temperature of 2-25 °C (do not freeze)

Shelf life

2 years

Active ingredient

Amino acids for parenteral nutrition

Conditions of release from pharmacies

By prescription

Dosage form

infusion solution