Pharmacological properties of the drug Kabiven peripheral
Pharmacodynamics. The pharmacological properties of the drug are determined by its composition. Fat emulsion (Intralipid 20%) The fat emulsion, which is part of Kabiven Peripheral, is a source of long-chain fatty acids (in particular essential ones), which are used in the body as a source of energy and for the construction of cell membranes. Intralipid in recommended doses does not affect hemodynamics. There were no clinically significant cases of deterioration in pulmonary function when the recommended infusion rate was observed. Cases of increased levels of liver enzymes in the blood have been reported in rare cases. After the end of parenteral nutrition, enzyme levels returned to initial values. Similar changes are observed during parenteral nutrition, which does not include a fat emulsion. Amino acids and electrolytes (Vamin 18 Novum) Amino acids are an integral part of proteins in regular food. They are used in the body for protein synthesis and partly in the process of gluconeogenesis. Infusion of amino acids leads to an increase in the level of metabolism and, accordingly, to an increase in heat production in the body. Glucose (glucose solution 11%) Glucose has the same pharmacodynamic properties as glucose, which takes part in normal metabolism. Pharmacokinetics Fat emulsion (Intralipid 20%) Intralipid is similar in its biological properties to endogenous chylomicrons. Unlike chylomicrons, Intralipid does not contain cholesterol esters or apolipoproteins. The phospholipid content is significantly higher in Intralipid than in chylomicrons. Intralipid is cleared from the bloodstream in the same way as chylomicrons. Exogenous fat particles are mainly hydrolyzed in the blood and taken up by LDL receptors in the liver and peripheral tissues. The rate of elimination is determined by the composition of the fat particles, the clinical and nutritional status of the patient, and the rate of infusion. The maximum fasting clearance of Intralipid is equivalent to 3.8 ± 1.5 g triglycerides/1 kg body weight/day. The rate of excretion and oxidation of fat emulsion accelerates during sepsis, as well as after injuries, and, on the contrary, slows down during renal failure and hypertriglyceridemia. Amino acids and electrolytes (Vamin 18 Novum) The pharmacokinetic characteristics of amino acids and electrolytes that are administered intravenously are the same as when they are supplied with food. However, amino acids from food proteins first enter the hepatic portal vein and only then enter the systemic circulation, whereas amino acids administered intravenously enter directly into the systemic circulation. Glucose (glucose solution 11%) The pharmacokinetic characteristics of glucose, which is administered by intravenous infusion, are the same as when taken with food.
Kabiven peripheral 1920 ml N4 emulsion for infusion
Release form
The emulsion for infusion, formed after mixing the contents of the three chambers of a three-chamber bag, is homogeneous and white.
Compound
Active ingredients: glucose 11% - 1180 ml; Vamin 18 Novum - 400 ml; Intralipid 20% - 340 ml.
Package
4 pieces, 1920 ml each
pharmachologic effect
Kabiven is a parenteral nutrition product. The effect of the drug is determined by the pharmacological activity of its components.
Pharmacodynamics
The pharmacological properties of the drug are determined by its composition.
Vamin 18 Novum is intended for parenteral nutrition of patients with various pathologies with an increased need for protein, when enteral nutrition is ineffective or impossible.
Glucose is an indispensable source of quickly released energy, which is also necessary for the metabolism of amino acids.
Intralipid is used for parenteral nutrition of patients as a source of energy and essential fatty acids. Intralipid is indicated for patients with essential fatty acid deficiency who are unable to independently replenish the normal balance of essential fatty acids through oral consumption. Intralipid contains purified soybean oil emulsified with purified egg phospholipids. The size of the lipid globules and the biological properties of the Intralipid emulsion are similar to those of endogenous chylomicrons. Unlike chylomicrons, Intralipid does not contain cholesteryl esters and apolipoprotein, and its phospholipid content is higher.
Pharmacokinetics
Fat emulsion
Intralipid is cleared from the bloodstream in the same way as chylomicrons. Exogenous fat particles are mainly hydrolyzed in the blood and taken up by LDL receptors in the liver and peripheral tissues. The rate of elimination is determined by the composition of the fat particles, the clinical and nutritional status of the patient, and the rate of infusion. The maximum fasting clearance of Intralipid emulsion is equivalent to (3.8 ± 1.5) g/kg/day triglycerides.
Amino acids and electrolytes
The pharmacokinetic characteristics of amino acids and electrolytes administered intravenously are the same as when supplied with food. However, amino acids from food proteins first enter the liver portal vein and only then into the systemic circulation, while amino acids administered into the vein enter directly into the systemic circulation.
Glucose
The pharmacokinetic characteristics of glucose administered by infusion are the same as when administered with regular food.
Indications
Parenteral nutrition for adults and children 2 years of age and older when oral or enteral nutrition is not possible, insufficient, or contraindicated.
Contraindications
- known hypersensitivity to egg or soy proteins or any auxiliary component of the drug;
- severe hyperlipidemia;
- severe liver failure;
- severe blood clotting disorders;
— congenital disorders of amino acid metabolism;
- severe renal failure in the absence of hemodialysis or hemofiltration;
- acute phase of shock;
- hyperglycemia requiring insulin administration in amounts of more than 6 units/hour;
- pathologically increased concentration in the blood plasma of any of the electrolytes included in the drug;
- general contraindications to infusion therapy: acute pulmonary edema, overhydration, decompensated heart failure, hypotonic dehydration;
- unstable conditions (for example, post-traumatic condition, uncompensated diabetes mellitus, acute myocardial infarction, decompensated metabolic acidosis, severe sepsis and hyperosmolar coma).
Carefully:
impaired lipid metabolism due to renal failure, diabetes mellitus, pancreatitis, liver dysfunction, hypothyroidism (with hypertriglyceridemia) or sepsis. When administering the drug Kabiven® central to patients with such disorders, careful monitoring of the concentration of triglycerides in the blood plasma is necessary. Kabiven® central is intended primarily for patients over 2 years of age. In children under 2 years of age, Kabiven® central can be used only for health reasons in the absence of special adapted amino acid solutions containing taurine (Aminoven infant). Premature and low birth weight babies may have impaired fat metabolism. Triglyceride levels should be carefully monitored.
Directions for use and doses
The drug is administered intravenously.
Kabivena peripheral has an osmolarity of 750 mOsm/l, and therefore the drug can be administered to adults and children into peripheral or central veins.
The infusion can be continued for as long as the patient’s clinical condition requires, based on the daily need for glucose, lipids and amino acids. The dose of the drug and the rate of infusion are determined by the patient’s body’s ability to remove lipids and metabolize glucose.
Kabiven peripheral is available in bags of three sizes, intended for patients with normal, moderately increased or decreased nutritional needs. Total parenteral nutrition may require supplementation with vitamins, electrolytes, and micronutrients.
The dose should be individualized, and when choosing the volume of the bag, the patient's condition, body weight and nutritional requirements should be taken into account.
In obese patients, the dose should be set based on ideal body weight.
In patients with moderate to severe catabolic stress with or without malnutrition, the amino acid requirement is 1-2 g/kg/day, which approximately corresponds to a nitrogen requirement of 0.15-0.3 g/kg/day. The energy requirement is 30-50 kcal/kg/day. This corresponds to 40 ml/kg/day.
In patients without catabolic stress, the amino acid requirement is 0.7-1 g/kg/day, which is approximately equal to the nitrogen requirement of 0.1-0.15 g/kg/day. The energy requirement is 20-30 kcal/kg/day. This corresponds to 27-40 ml of Kabiven peripheral per 1 kg of body weight per day.
Side effects
Allergic reactions:
anaphylactic reaction, fever, chills, trembling, skin rash, urticaria.
From the respiratory system:
changes in breathing (tachypnea).
From the cardiovascular system:
decrease or increase in blood pressure.
From the digestive system:
increased activity of liver enzymes, abdominal pain.
From the hematopoietic system:
hemolysis, reticulocytosis.
Local reactions:
thrombophlebitis when infused into peripheral veins.
Other:
headache, priapism.
When administered correctly, side effects are extremely rare.
Interaction
In therapeutic doses, heparin causes a transient release of lipoprotein lipase into the bloodstream, which can lead initially to increased lipolysis in the blood plasma, and then to a transient decrease in TG clearance.
Insulin can also affect lipase activity, but there is no evidence of its adverse effect on the therapeutic efficacy of the drug.
Vitamin K1, contained in soybean oil, is an antagonist of coumarin derivatives, so it is recommended to carefully monitor blood clotting in patients receiving these drugs.
Kabiven peripheral can only be mixed with those medications and nutritional solutions for which compatibility with it has been confirmed, for example: Vitalipid N for adults and Vitalipid N for children; Soluvit N; Addamel N; Dipeptic. Mixing solutions should be carried out under aseptic conditions.
Overdose
Symptoms:
due to impaired ability to excrete fat, fat overload syndrome may develop - hyperlipidemia, fever, hepatosplenomegaly, anemia, leukopenia, thrombocytopenia, coagulopathy and coma.
Treatment:
cessation of lipid infusion, symptomatic therapy.
Best before date
2 years.
Storage conditions
The drug should be stored out of the reach of children at a temperature not exceeding 25°C.
Use of the drug Kabiven peripheral
For IV infusions. Administration into central and peripheral veins is allowed. To reduce the risk of developing thrombophlebitis when administered into peripheral veins, it is recommended to change the catheter installation site once a day. Fat excretion capacity and glucose metabolism must be taken into account when dosing and determining the infusion rate. The dose must be selected individually and the size of the drug container must be selected taking into account the patient’s condition, body weight and nutritional needs. The nitrogen requirement for protein synthesis depends on the patient's condition (nutritional status, level of catabolic stress). Under normal nutritional status, the patient needs 0.10–0.15 g nitrogen/1 kg body weight/day. For patients with moderate to severe catabolic syndrome with or without malnutrition, the nitrogen requirement is 0.15–0.30 g nitrogen/1 kg body weight/day (1.0–2.0 g amino acid/1 kg body weight/ days). The introduction of such an amount of amino acids also requires the introduction of 2.0–6.0 g of glucose and 1.0–2.0 g of fat. The total energy requirement depends on the patient's condition and is approximately 20–30 kcal per 1 kg of body weight/day. For overweight patients, the dose should be calculated based on ideal body weight. Kabiven Peripheral is available in containers of 3 different volumes, which allows the drug to be used for use in patients with high, medium or low need for parenteral nutrition. When carrying out parenteral nutrition, there may be a need to add vitamins, individual electrolytes or microelements. Use in adults : 27–40 ml of Kabiven Peripheral per 1 kg of body weight/day (which corresponds to 0.1–0.15 g of nitrogen/1 kg of body weight/day or 0.7–1.0 g of amino acids/1 kg of body weight /day. The energy value of this corresponds to 20–30 kcal/1 kg of body weight/day). Use in children aged 2–10 years Infusion in children aged 2–10 years should be started with low doses: 14–28 ml of Kabiven Peripheral per 1 kg of body weight/day (corresponding to 0.49–0.98 g of fat/ 1 kg body weight/day, 0.34–0.67 g amino acids/1 kg body weight/day and 0.95–1.9 g glucose/1 kg body weight/day), increase dosage by 10–15 ml/ 1 kg every other day until the maximum dose of 40 ml of Kabiven Peripheral per 1 kg of body weight/day is reached. Children aged 10 years and older Dosing of Kabiven Peripheral is the same as for adults. Children under 2 years of age The use of Kabiven Peripheral in children under 2 years of age is not recommended. Infusion rate The maximum infusion rate for glucose is 0.25 g/1 kg body weight/hour. The maximum rate of amino acid administration should not exceed 0.1 g/1 kg body weight/hour. The maximum infusion rate for fats is 0.15 g/1 kg body weight/hour. The infusion rate of the drug should not exceed 3.7 ml/1 kg body weight/h, which corresponds to a dose of glucose, amino acids and lipids of 0.25 g/1 kg body weight/h, 0.09 g/1 kg body weight/h, and 0.13 g/1 kg body weight/h, respectively. The recommended duration of drug infusion is 12–24 hours. The maximum daily dose is 40 ml/1 kg body weight/day, this corresponds to one container (maximum capacity) for patients weighing 64 kg and provides 0.96 g of amino acids/1 kg body weight/day (0.16 g nitrogen/1 kg body weight/day), 25 kcal/1 kg body weight/day non-protein energy (2.7 g glucose/1 kg body weight/day and 1.4 g lipids/ 1 kg body weight/day). Instructions for using the 3-chamber container Remove the outer bag by tearing it at the cut and pulling it along the bag. With the thumbs and forefingers of both hands, firmly grasp the side walls of the bag above the middle of the latch that separates chambers 1 and 2. Pull the walls of the bag to the sides and completely open the latch. Open the lock between chambers 2 and 3 in the same way. Mix the contents by turning the bag over several times. If it is necessary to introduce an additive (with known compatibility, for example, vitamin preparations, microelements), wipe the inlet membrane with an antiseptic. Place the package on the table; Holding the base of the inlet, insert the needle completely through the center of the membrane and inject the additive (of known compatibility). Before adding the second additive, thoroughly mix the contents by turning the bag over several times. Remove the cap from the infusion system needle by grasping the ring with your thumb and forefinger and pulling the ring up. Use an infusion system without air access or block air access in a system that does have air access. Place the bag on a flat surface. Holding the bag with the inlet facing up, insert the needle completely through the membrane. To securely fasten the needle, it must be inserted completely. Hang the bag on the stand and follow the instructions for the infusion set and infusion pump. The second way to open the latches is to place the bag on a flat surface and roll it up from the handle side until the latches open. Mix the contents by turning the bag several times. Note: separate administration of components from separate chambers of Kabiven Peripheral is technically impossible (with the exception of Intralipid), although each component of the drug (glucose solution, Vamin and Intralipid) can be used in the form of separate drugs.
Compound
Emulsion for infusion 1920 ml contains:
- soybean oil 68 g
- dextrose (glucose) monohydrate 143 g, which corresponds to the content of anhydrous dextrose 130 g
- L-alanine 6.4 g
- L-arginine 4.5 g
- L-aspartic acid 1.4 g
- L-valine 2.9 g
- L-histidine 2.7 g
- glycine (aminoacetic acid) 3.2 g
- L-glutamic acid 2.2 g
- L-isoleucine 2.2 g
- L-leucine 3.2 g
- L-lysine hydrochloride 4.5 g, corresponding to a lysine content of 3.6 g
- L-methionine 2.2 g
- L-proline 2.7 g
- L-serine 1.8 g
- L-tyrosine 92 mg
- L-threonine 2.2 g
- L-tryptophan 760 mg
- L-phenylalanine 3.2 g
- calcium chloride dihydrate 390 mg, which corresponds to a calcium chloride content of 300 mg
- sodium glycerophosphate (anhydrous) 2 g
- magnesium sulfate heptahydrate 1.3 g, which corresponds to the content of magnesium sulfate 640 mg
- potassium chloride 2.4 g
- sodium acetate trihydrate 3.3 g, which corresponds to a sodium acetate content of 2 g
Contraindications to the use of the drug Kabiven peripheral
Hypersensitivity to egg and soy proteins or to any of the components of the drug; severe hyperlipidemia; severe liver failure; severe disorders of the blood coagulation system; hereditary disorders of amino acid metabolism; severe renal failure in patients who do not undergo hemodialysis or hemofiltration; acute phase of shock; hyperglycemia, requiring insulin administration in doses of 6 units/hour; pathologically increased concentration in the blood plasma of any of the electrolytes included in the drug; the presence of general contraindications to infusion therapy (pulmonary edema, overhydration, heart failure, hypotonic dehydration); hemophagocytic syndrome; unstable condition (in particular, condition after injury, decompensated diabetes mellitus, myocardial infarction in the acute phase, decompensated metabolic acidosis, severe sepsis and hyperosmolar coma); age up to 2 years.
Side effects of the drug Kabiven peripheral
Infusion may cause an increase in body temperature (in no more than 3% of cases); tremor, pale skin, nausea/vomiting (in less than 1% of cases). Thrombophlebitis of peripheral veins may occur, as with the administration of any other hypertensive solution for infusion. Other side effects, when administered correctly, are observed in isolated cases: allergic reactions (anaphylactic reaction, fever, chills, skin rash, urticaria, etc.); tachypnea; decrease or increase in blood pressure; hemolysis; reticulocytosis; abdominal pain, headache, drowsiness; priapism.
Special instructions for the use of the drug Kabiven peripheral
No special studies have been conducted on the safety of the drug during pregnancy and lactation. Before prescribing Kabiven Peripheral, pregnant women and women during breastfeeding should assess the risk/benefit ratio. The ability to influence reaction speed when driving vehicles and working with other complex mechanisms has not been studied; The drug is intended for use only in a hospital setting. When using the drug, you should monitor the process of lipid removal by determining the level of TG in the blood plasma 5–6 hours after the last use of fats. The concentration of TG in the blood plasma during infusion should not exceed 3 mmol/l. The volume of the container for administration should be selected individually. Each package is intended for one-time use. It is necessary to accurately calculate the volume of drug to be administered, which should be adjusted taking into account the fluid balance and nutritional status of the patient. Severe electrolyte and fluid imbalances (eg, abnormally high or low serum electrolyte levels) should be corrected before infusion. At the beginning of the infusion, the patient's condition should be monitored. The infusion should be stopped if the patient's condition worsens. Because any central venous infusion carries an increased risk of infection, asepsis should be used during catheter insertion or manipulation to avoid infection. Kabiven Peripheral should be used with caution in patients with reduced lipid metabolism, which is observed in renal failure, decompensated diabetes mellitus, pancreatitis, liver dysfunction, hypothyroidism (with hypertriglyceridemia), and sepsis. The use of Kabiven peripheral in such patients should be carried out under mandatory constant monitoring of the level of TG concentration in the blood serum. It is necessary to regularly monitor the concentration of glucose and electrolytes in the blood plasma, as well as plasma osmolarity, water balance, COR and liver enzyme activity. With prolonged administration of lipids, the cellular composition of the blood and blood coagulation parameters should be monitored. In patients with renal failure, it is necessary to control the balance of phosphate and potassium to avoid the development of hyperphosphatemia and hyperkalemia. The amount of additional electrolytes should be determined by regularly monitoring their concentration, taking into account the clinical condition of the patient. This preparation does not contain vitamins and microelements. The addition of microelements and vitamins is allowed. When adding vitamins, calculations are used as in pediatrics. Parenteral infusion should be used with caution in patients with metabolic acidosis (eg lactic acidosis), since an increase in serum osmolarity requires rehydration. Kabiven Peripheral should be used with caution in patients with a tendency to retain electrolytes. If any symptoms or signs of allergic reactions occur, the infusion should be stopped immediately. The presence of lipids in the drug may alter the results of some laboratory tests (for example, bilirubin concentration, LDH activity, blood oxygenation level, hemoglobin level) if the blood sample was taken before sufficient removal of lipids from the bloodstream. In most patients, injected lipids are eliminated within 5–6 hours. IV administration of amino acids may be accompanied by increased renal excretion of trace elements, especially zinc. Patients requiring long-term intravenous nutrition may require additional administration of microelements. In malnourished patients, the initiation of parenteral nutrition can cause fluid imbalance, which leads to the development of pulmonary edema and congestive heart failure. In addition, over a period of 24–48 hours, a decrease in the concentrations of potassium, phosphorus, magnesium and water-soluble vitamins in the blood plasma may be observed. It is recommended to initiate parenteral nutrition slowly, subject to strict monitoring and appropriate adjustment of the amount of fluid, electrolytes, vitamins and trace elements. Kabiven Peripheral should not be administered through 1 catheter simultaneously with whole blood or its preparations. Patients with hyperglycemia may require insulin administration. Thrombophlebitis of peripheral veins can occur with the administration of any hypertonic infusion solution. The risk of developing thrombophlebitis depends on many factors: the type of catheter, its diameter and length, duration of infusion, pH and osmolality of the solution, the presence of infection, and the number of manipulations on the vein. It is recommended not to use the vein through which parenteral nutrition is administered to administer other solutions.
pharmachologic effect
Preparation for parenteral nutrition.
The effect of the drug is determined by the pharmacological activity of its components.
Vamin 18 Novum is intended for parenteral nutrition of patients with various pathologies with an increased need for protein, when enteral nutrition is ineffective or impossible.
Intralipid is used for parenteral nutrition as a source of energy and essential fatty acids. Intralipid is indicated for patients with a deficiency of essential fatty acids who are unable to independently replenish the normal balance of essential fatty acids by oral administration. Intralipid contains purified soybean oil emulsified with purified egg phospholipids. The sizes of lipid globules and the biological properties of Intralipid are similar to those of endogenous chylomicrons. Unlike chylomicrons, Intralipid does not contain cholesteryl esters and apolipoprotein, and its phospholipid content is higher.
Dextrose (glucose) is an irreplaceable source of quickly released energy, necessary, incl. and for amino acid metabolism.
With simultaneous infusion of a dextrose solution and a lipid emulsion, the risk of developing thrombophlebitis is reduced (due to a decrease in the osmolarity of dextrose during dilution), which always exists when hypertonic solutions are infused into peripheral veins.
Interactions of the drug Kabiven peripheral
After opening the clamps and mixing the 3 solutions, compatible additives can be added to the mixture through the inlet. Heparin in therapeutic doses causes the release of lipoprotein lipase into the bloodstream, which can lead first to increased lipolysis in the blood plasma, and then to a decrease in TG clearance. Insulin can also affect lipase activity, but there is no data regarding the adverse effect of this fact on the therapeutic effectiveness of the drug. Vitamin K1, contained in soybean oil, is an antagonist of coumarin derivatives, so it is recommended to carefully monitor blood clotting in patients receiving these drugs. Adding any medications or other solutions to Kabiven Peripheral is possible only if their compatibility is known.
Overdose of the drug Kabiven peripheral, symptoms and treatment
An impaired ability to eliminate fat can lead to the development of fat overload syndrome. This may result from overdose, but may also occur at the recommended infusion rate if the patient's clinical condition changes dramatically and severe renal or hepatic impairment develops. Fat overload syndrome is characterized by hyperlipidemia, fever, hepatosplenomegaly, anemia, leukopenia, thrombocytopenia, coagulopathy and coma. If this occurs, the infusion must be stopped. Nausea, vomiting, and excessive sweating may occur if the recommended rate of amino acid infusion is exceeded. In addition, overdose leads to disturbances in water-electrolyte balance, hyperglycemia and hyperosmolality. If symptoms of overdose occur, the infusion rate should be reduced or the infusion should be stopped. In case of severe overdose, hemodialysis, hemofiltration or hemodiafiltration are prescribed.
Directions for use and doses
The drug is administered intravenously.
Kabiven peripheral has an osmolarity of 750 mOsm/l, and therefore the drug can be administered to adults and children into peripheral or central veins.
The infusion can be continued for as long as the patient’s clinical condition requires, based on the daily need for glucose, lipids and amino acids. The dose of the drug and the rate of infusion are determined by the patient’s body’s ability to remove lipids and metabolize glucose.
Kabiven peripheral is available in bags of three sizes, intended for patients with normal, moderately increased or decreased nutritional needs. Total parenteral nutrition may require supplementation with vitamins, electrolytes, and micronutrients.
The dose should be individualized, and when choosing the volume of the bag, the patient's condition, body weight and nutritional requirements should be taken into account.
In obese patients, the dose should be set based on ideal body weight.
Storage conditions for the drug Kabiven peripheral
At a temperature not higher than 25 °C. Do not freeze! After opening the clamps, the chemical and physical stability of the mixed contents of the 3 chambers is maintained for 24 hours at a temperature of 25 °C. To ensure microbiological safety, the mixture should be used immediately after the addition of additives. If the mixture is not used immediately, then provided that aseptic conditions are observed when introducing additives, the emulsion mixture can be stored for up to 6 days at a temperature of 2–8 ° C, after which the mixture must be used within 24 hours.
List of pharmacies where you can buy Kabiven peripheral:
- Moscow
- Saint Petersburg