Olikinomel

Oliclinomel is a combination drug used for parenteral nutrition of patients.

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Indications Olikinomel

It is used as a parenteral method of nutrition for children aged 2 years and older and for adults in situations where natural nutrition is not possible (or this method is contraindicated or is not sufficiently effective).

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Release form

The product is released in the form of an infusion emulsion (it is formed by mixing the contents of all 3 chambers of the container).

Oliclinomel n4-550е

Oliklinomel n4-550e is available in 3-chamber containers with a capacity of 1 l (6 pieces), 1.5 l (4 pieces) or 2 l (4 pieces).

Oliclinomel n7-1000е

Oliklinomel n7-1000e is produced in 3-chamber containers with a volume of 1 l (in the amount of 6 pieces), 1.5 or 2 l (in the amount of 4 pieces), or 2.5 l (2 pieces).

Pharmacodynamics

The mixture consisting of 3 elements is used as a source that supports energy and, in addition, protein metabolism. The presence of organic nitrogen is provided by L-AMC, and energy saturation occurs due to the presence of fatty acids together with dextrose. Along with this, the mixture also contains electrolytes.

Moderate levels of EFA components within the mixture increase the level of higher EFA derivatives within the body, replenishing the deficiency of these substances.

Large amounts of α-tocopherol are found in olive oil. This element, in combination with a small number of PUFAs, increases the tocopherol levels in the body and also reduces lipid peroxidation.

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Pharmacokinetics

The components of the infusion emulsion (these are electrolytes together with amino acids, as well as lipids together with dextrose) are metabolized and excreted from the body in a similar way to these processes in the case of separate use of the elements.

The pharmacokinetics of amino acids administered intravenously are largely the same as those of amino acids obtained through natural diet (but in this situation, the amino acids contained within food proteins undergo hepatic passage before entering the bloodstream).

The rate of excretion of lipid emulsion components is determined by the size of these particles. Small lipid elements are eliminated more slowly, but at the same time are subject to breakdown more quickly under the influence of the substance lipoprotein lipase.

The size of the lipid emulsion components within the mixture roughly corresponds to the size of chylomicrons, resulting in similar excretion rates.

Dosing and administration

The drug is administered to patients intravenously - through a peripheral or central vein. The portion size, as well as the duration of administration, depend on the patient's need for this type of nutrition and are determined by his condition.

Adults require an average of 0.16-0.35 g/kg of organic nitrogen per day (the AMC value is about 1-2 g/kg/day). The fluctuation in energy requirements is determined by the patient's condition and the intensity of the catabolic processes. Their average values are within 25-40 kcal/kg/day.

The maximum daily dose is 40 ml/kg (this corresponds to 3.2 g of dextrose, as well as 0.88 g of AMC, as well as 0.8 g of lipids per kilogram), which is 2800 ml of infusion emulsion, which is sufficient for administration to a person weighing 70 kg.

Children over 2 years of age require on average 0.35-0.45 g/kg of organic nitrogen per day (accordingly, in AMC this leaves approximately 2-3 g/kg/day). The average energy requirements of such patients are 60-110 kcal/kg/day.

The dose size is determined by the amount of liquid that has entered the body, as well as the person's daily protein requirement. In addition, the state of water metabolism must also be taken into account.

A maximum of 100 ml/kg of the drug can be administered per day (which corresponds to 8 g of dextrose and in addition 2.2 g of AMC, as well as 2 g of lipids per kilogram). In general, it is prohibited to exceed the dose of 17 g/kg/day of dextrose or 3 g/kg/day of amino acids or lipids (except in special situations).

The highest possible infusion rate is 3 ml/kg/hour, which is equal to a maximum of 0.24 g dextrose, 0.06 g amino acids, and 0.06 g lipids per 1 kg/hour.

When storing Oliclinomel at low temperatures, the mixture of the medicine must be heated to 25 ^o C before starting the infusion.

The introduction of the mixture can only begin after the partitions between the 3 chambers of the container have been destroyed, resulting in the mixing of all elements of the drug.

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Use Olikinomel during pregnancy

At the moment, there is no reliable information about the use of Oliklinomel during lactation or pregnancy. Therefore, if there is a need to use it during this period, before making a decision, the doctor must evaluate the ratio of help to the woman and the risk to the fetus.

Contraindications

Main contraindications:

• severe renal failure with no possibility of dialysis or hemofiltration;
• severe stage of liver failure;
• congenital form of amino acid metabolism disorder;
• severe stages of blood clotting disorder;
• severe degree of hyperlipidemia;
• presence of hyperglycemia;
• problems with electrolyte metabolism, increased plasma levels of any of the electrolytes that are part of the mixture;
• development of lactic acidosis;
• hyperhydria, pulmonary edema, decompensated stage of heart failure, as well as dehydration with a lack of salts;
• instability in health status (such as decompensated stage of diabetes mellitus, severe form of post-traumatic stress disorder, acute stage of myocardial infarction or hemorrhagic shock, as well as severe form of sepsis or metabolic acidosis and non-ketotic coma);
• children under 2 years of age;
• the presence of intolerance to the components of the drug.

Use with caution in individuals with increased plasma osmolarity, adrenal or cardiac insufficiency, or lung disease.

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Side effects Olikinomel

Possible side effects include the development of hyperhidrosis, hyperthermia, as well as nausea, tremors and headaches, as well as respiratory distress.

In addition, a transient increase in the level of biochemical markers of liver function (including transaminases, alkaline phosphatase and bilirubin) is sometimes observed, especially in the case of prolonged use of this nutritional method (over a period of several weeks).

Jaundice or hepatomegaly may occasionally occur.

Due to the weakened ability to eliminate lipids contained in the drug from the bloodstream, the development of a syndrome associated with lipid overload should be expected. This disorder can be provoked by an overdose or appear at the beginning of the infusion. As a result, a sudden and sharp deterioration in the patient's condition is observed. This syndrome manifests itself in the form of fever, hyperlipidemia, hepatomegaly, as well as fatty liver infiltration, leukopenia and thrombocytopenia, as well as anemia, coma and coagulation disorders. These signs are treatable by stopping the infusion of lipid emulsion.

At the same time, there is information that thrombocytopenia occasionally developed in children after using emulsion infusion.

The drug contains soybean oil. This component can occasionally cause severe allergic symptoms.

The infusion must be stopped immediately if the patient develops signs of an allergic reaction (including shivering, difficulty breathing, fever, and skin rash).

Overdose

Signs of poisoning: development of acidosis, hypervolemia, tremors, as well as vomiting with nausea and destruction of electrolyte balance. They occur due to overdose or as a result of exceeding the required infusion rate. After the introduction of excessive portions of drugs, glucosuria, hyperglycemia or hyperosmolar syndrome may occur.

To eliminate the disorder, the first step is to immediately stop the infusion. By quickly stopping the infusion, the disorders that have arisen and their symptoms can be quickly eliminated and cured.

In cases of severe intoxication, hemofiltration, hemodialysis, or hemodiafiltration procedures may be required.

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Interactions with other drugs

The infusion emulsion should not be administered in combination with blood medications using the same catheter, as this may cause pseudoagglutination.

When blood is collected before lipids are eliminated from plasma (often after 5-6 hours from the end of the infusion), they can affect the values of individual laboratory tests. For example, lipids can change the level of hemoglobin with bilirubin, as well as oxygen saturation and lactate dehydrogenase.

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Storage conditions

Oliclinomel should be kept out of the reach of small children, not frozen, at temperatures between 2-25°C. The mixed emulsion should be stored at 2-8°C (for 7 days) or 25°C (maximum 48 hours).

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Shelf life

Oliklinomel can be used for 2 years from the date of manufacture of the medicinal product.