Kabiven central, container 1540ml, 4pcs

Composition

A 1540ml bag contains:

Glucose 19% 790 ml,

Vamin 18 Novum 450 ml,

Intralipid 20% 300 ml,

Energy value 1400 kcal

Pharmacological action

Kabiven central – a drug 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.

Glucose is an essential source of fast-releasing 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 a deficiency of essential fatty acids, unable to independently replenish the normal balance of essential fatty acids by oral consumption.

Intralipid contains purified soybean oil emulsified with purified egg phospholipids. The size of lipid globules and the biological properties of Intralipid are similar to those of endogenous chylomicrons. Unlike chylomicrons, Intralipid does not contain cholesterol esters and apolipoprotein, and the content of phospholipids in it is higher.

Three-chamber bag with a unique shape, aluminum-free ports.

Indications

Balanced parenteral nutrition for adults and children (including long-term nutrition).

Use during pregnancy and lactation

Special safety studies of Kabiven central during pregnancy and lactation have not been conducted.

Before prescribing Kabiven central to pregnant and lactating women, the doctor should evaluate the risk / benefit ratio.

Contraindications

• Identified hypersensitivity to egg or soy proteins or to 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 the use of insulin in the amount of more than 6 Units/hour.
• Pathologically elevated concentration in the blood plasma of any of the electrolytes included in the preparation.
• General contraindications to infusion therapy:   acute pulmonary edema, hyperhydration, decompensated heart failure, and hypotonic dehydration.
• Hemophagocytic syndrome.
• Unstable conditions (e. g. post-traumatic stress disorder, uncompensated diabetes mellitus, acute myocardial infarction, decompensated metabolic acidosis, severe sepsis, and hyperosmolar coma).

With caution: impaired lipid metabolism due to renal failure, diabetes mellitus, pancreatitis, impaired liver function, hypothyroidism (with hypertriglyceridemia) or sepsis; metabolic acidosis (e. g. lactic acidosis); increased blood osmolarity; need for plasma replacement therapy; tendencies to electrolyte retention.

Side effects

Data on side effects when administered correctly are extremely rare:

• allergic reactions (anaphylactic reaction, fever, chills, shivering,
• skin rash, hives)
• changes in respiration (tachypnea) and arterial hyper-or hypotension,
• increased activity of liver enzymes,
• hemolysis,
• reticulocytosis.
• abdominal pain,
• headache,
• priapism.

Interaction

Heparin in clinically administered doses causes a transient release of lipoprotein lipase into the bloodstream, which can lead initially to increased lipolysis in blood plasma, and then to a transient decrease in triglyceride clearance.

Insulin can also affect lipase activity, but there are no data on the adverse effect of this factor on the therapeutic value of the drug.

Vitamin K-1 contained in soy oil is an antagonist of coumarin derivatives, so it is recommended to carefully monitor blood clotting in patients receiving these drugs.

Compatibility

Kabiven central can only be mixed with those medicines and nutrient solutions for which compatibility with it is confirmed:

Mixing of solutions should be carried out under aseptic conditions.

How to take, course of use and dosage

Intravenous, drip, only in the central veins. The infusion can be continued for as long as the patient’s clinical condition requires, based on the daily need for dextrose, lipids and amino acids.

The dosage and rate of infusion are determined by the patient’s ability to remove lipids and metabolize dextrose.

Kabiven Central is available in bags of four sizes, designed for patients with normal, moderately increased or reduced nutritional needs. Complete parenteral nutrition may require the addition of vitamins, electrolytes, and trace elements.

The dose should be selected individually, and when choosing the size of the bag, the patient’s condition, body weight and nutritional needs should be taken into account.

In obese patients, the dose should be adjusted based on the ideal body weight.

In patients with moderate or severe catabolic stress with or without malnutrition, the amino acid requirement is 1.0-2.0 g / kg / day, which is equal to the nitrogen requirement of 0.15-0.30 g/kg/day.

In patients without severe catabolic stress, the amino acid requirement is 0.7-1.3 g / kg / day, which is equal to the nitrogen requirement of 0.10-0.20 g/kg/day. This corresponds to 19-38 ml of Kabiven central per 1 kg of body weight per day.

Maximum daily dose

Adults 40 ml / kg / day. It is equal to one bag (maximum size – 2566 ml) patient weight of 64 kg and ensures the supply of 1.3 g of amino acids/kg/day (0.21 g of nitrogen/kg/day),31 kcal/kg/day of non-protein energy,3.9 g of glucose/kg/day and 1.6 g of fat/kg/day.

The maximum daily dose depends on the patient’s clinical condition and may vary.

Detidose is determined by the patient’s ability to metabolize individual nutrients.

Infusion in children (2 to 10 years of age) should start with low doses (14-28 ml / kg/day), the dose should be increased by 10-15 ml / kg / day, up to a maximum of 40 ml / kg / day.

In children over 10 years of age, the same doses can be used as in adults.

Kabiven Central is intended primarily for patients over 2 years of age. In children under 2 years of age, Kabiven Central can be used in the absence of special adapted amino acid solutions containing taurine.

Infusion rate: The maximum dextrose infusion rate is 0.25 g / kg / hour.

The dose of amino acids should not exceed 0.1 g / kg / hour.

The intake of lipids should not exceed 0.15 g / kg / hour.

The infusion rate of Kabiven central should not exceed 2.6 ml / kg / h, which corresponds to the infusion rate of glucose 0.25 g / kg / h, amino acids 0.09 g/kg / h and fat 0.13 g/kg/h. The recommended duration of Cabiven central infusion is 12-24 hours.

The use of Kabiven central can be continued for as long as the patient’s clinical condition requires, based on the daily need.

Instructions for using a three-chamber bag

• Remove the outer bag by tearing it at the cut point 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 retainer that separates chambers 1 and 2. Pull the sides of the bag to the sides and open the retainer completely.
• If it is necessary to introduce an additive (with known compatibility, for example, preparations of vitamins, trace elements)  wipe the inlet membrane with an antiseptic.
• Place the bag on the table; hold the base of the inlet, fully insert the needle through the center of the membrane, and insert the additive (with known compatibility). Before adding another additive, mix the contents thoroughly by turning the bag over several times.
• Similarly, open the lock between chambers 2 and 3. Mix the contents by turning the bag over several times.
• Remove the cap from the infusion system needle by holding the ring with your thumb and forefinger and pulling the ring up. Use the infusion system without air access, or block the air access on a system that has air access.
• Place the bag on a flat surface. While holding the bag with the outlet opening facing up, fully insert the needle through the membrane, turning and pushing it if necessary. To secure the needle securely, it must be inserted completely.
• Hang the bag on the rack and follow the instructions for the infusion system and infusion pump.
• Another way to open the retainers: place the bag on a flat surface and roll it up on the handle side until the retainers open. Mix the contents thoroughly by turning the bag over several times.

Note: Separate use of components from separate chambers of Kabiven central is not possible, although each component of Kabiven central: Vamin, Intralipid and glucose solution can be used as separate preparations.

Overdose

• Fat overload syndrome.
• Impaired ability to remove fat can lead to the development of fat overload syndrome. This may be the result of an overdose, but it can also occur at the recommended infusion rate if the patient’s clinical condition changes dramatically and severe renal or hepatic insufficiency develops.
• Fat overload syndrome is characterized by hyperlipidemia, fever, hepatosplenomegaly, anemia, leukopenia, thrombocytopenia, coagulopathy, and coma.

Treatment: discontinuation of lipid infusion, symptomatic therapy.

Special instructions

Cabiven Central solutions have an osmolality of 1060 mOsm / kg of water and therefore are not suitable for intravenous use into peripheral veins in both adults and children due to the risk of developing thrombophlebitis.

When Cabiven is administered to patients with impaired lipid metabolism due to renal failure, diabetes mellitus, pancreatitis, impaired liver function, hypothyroidism (with hypertriglyceridemia) or sepsis, careful monitoring of the concentration of triglycerides in the blood plasma is necessary;

When using the drug, the ability to remove lipids should be monitored by measuring the concentration of triglycerides in blood plasma 5-6 hours after the last fat intake.

You should carefully calculate the volume of the drug administered and adjust it in accordance with the water balance and nutritional status. Each container is intended for single use.

Disturbances in the electrolyte and water balance (e. g. abnormally high or low plasma electrolyte levels) should be corrected prior to the infusion.

At the beginning of any intravenous infusion, especially careful monitoring of the patient is required. Since any central vein infusion is associated with an increased risk of infection, strict aseptic procedures should be followed during catheter insertion or handling to avoid infection.

It is necessary to regularly check the concentration of glucose and electrolytes in the blood plasma, as well as osmolarity, water balance, acid-base state and activity of liver enzymes.

With prolonged use of lipids, the cellular composition of the blood and blood clotting parameters should be monitored.

In this preparation, there are no vitamins and trace elements, so for a complete parenteral nutrition, they should be administered additionally. To replenish them, it is recommended to use Vitalipid adult or Vitalipid children, Soluvit, Addamel

If any symptoms or signs of allergic reactions occur, the infusion should be stopped immediately.

The presence of lipids in Kabiven central can change the results of some laboratory tests (e. g., bilirubin concentration, lactate dehydrogenase activity, hemoglobin oxygen saturation), if the blood sample was obtained before sufficient removal of lipids from the bloodstream. In most patients, the introduced lipids are eliminated in 5-6 hours.

Intravenous use of amino acids may be accompanied by increased renal excretion of trace elements, especially zinc. Patients requiring long-term intravenous nutrition may require additional use of trace elements.

In severely malnourished patients, the initiation of parenteral nutrition can cause a shift in the water balance, leading to pulmonary edema and congestive heart failure. In addition, within 24-48 hours in the blood plasma, there may be a decrease in the concentrations of potassium, phosphorus, magnesium and water-soluble vitamins. It is recommended to start parenteral nutrition slowly with careful monitoring and appropriate correction of the amount of fluid, electrolytes, vitamins and trace elements.

Premature babies and babies with low birth weight may have impaired fat metabolism. Triglyceride levels should be carefully monitored. Due to the absence of certain amino acids in the preparation, which are considered conditionally irreplaceable for newborns, it is not recommended to use Kabiven preparations in this group of patients, if it is possible to mix Intralipid with solutions of amino acids specifically intended for this category of patients.

Cabiven Central should not be administered through a single catheter and simultaneously with blood or blood preparations due to the risk of pseudoagglutination.

Patients with hyperglycemia may require insulin use.

A venous catheter, through which full parenteral nutrition is administered, is not recommended for intravenous use of other solutions and drugs.

Any leftovers from the open container must be destroyed.

Form of production

Suspension for infusions.

Storage conditions

At a temperature not exceeding 25°CC in an outer bag, out of the reach of children. Do not freeze it.

Shelf life

2 years in the outer bag.

Active ingredient

Amino acids for parenteral nutrition

Conditions of release from pharmacies

By prescription

Dosage form

emulsion for infusions