2010/06/23

Kabiven

Composition, structure and packing

Kabiven Central comes in three-chamber bag in two volumes: 1540 ml and 2053 ml. The bag contains a volume of 1540 ml: p-p dextrose 19% - 790 ml, p-p Vamin Novum 18 - 450 ml Intralipid 20% - 300 ml. Emulsion for infusion, which is formed after mixing the contents of the three chambers three-chamber bag, homogeneous, white. The composition of the emulsion after mixing the contents of 3 chambers (1540 ml):

Fat 60 g, including: purified soybean oil 60 g purified egg phospholipids, 3.6 g;
glycerol (anhydrous) 6.6 PM

Carbohydrates: Dextrose monohydrate 165 g, which corresponds to the content of dextrose anhydrous 150 g.

Amino acids 51 g, including: alanine 7.2 g;
arginine, 5.1 g;
aspartic acid, 1.5 g;
valine, 3.3 g;
histidine, 3.1 g;
glycine, 3.6 g;
glutamic acid 2.5 g;
isoleucine 2.5 g;
leucine, 3.6 g;
lysine hydrochloride 5.1 g, which corresponds to the content of lysine 4.1 g;
methionine 2.5 g;
proline, 3.1 g;
Serine 2 g;
Tyrosine 100 mg;
threonine, 2.5 g;
tryptophan 860 mg;
phenylalanine 3.6 PM

Electrolytes: calcium chloride x 2H2O 440 mg, which corresponds to the content of calcium chloride, 330 mg sodium
glycerophosphate (anhydrous) 2.3 g;
magnesium sulfate x 7H2O 1.5 g, which corresponds to the content of magnesium sulfate 720 mg
potassium chloride, 2.7 g sodium acetate x 3N2O 3.7 g, which corresponds to the content of sodium acetate, 2.2 PM

Equivalent content: Na + 48 mmol K + 36 mmol;
Mg2 + 6 mmol;
Ca2 + 3 mmol;
phosphate 15 mM;
sulphate 6 mmol,
Cl-70 mmol;
CH3COO-58 mM;
nitrogen, 8.1 g;
osmolality of about 1230 mOsm / kg;
water osmolarity of about 1060 mOsm / l;
pH 5.4-5.8 energy: total 1400 kkal/1540 ml;
nonprotein 1200 kkal/1540 ml. Excipients: Water d / and.

2053 ml bag volume contains: p-p dextrose 19% - 1053 ml, p-p Vamin 1918 Novum - 600 ml Intralipid 20% - 400 ml.

Emulsion for infusion, which is formed after mixing the contents of the three chambers three-chamber bag, homogeneous, white. The composition of the emulsion after mixing the contents of 3 chambers (2053 ml):

Fat 80 g, including: purified soybean oil 80 g;
purified egg phospholipids 4.8 g;
glycerol (anhydrous) 8.8 PM

Carbohydrates: Dextrose monohydrate 220 g, which corresponds to the content of dextrose anhydrous 200 g.

Amino acids 68 g, including:
alanine, 9.6 g;
arginine, 6.8 g;
aspartic acid 2 g;
valine, 4.4 g;
histidine 4.1 g,
glycine, 4.7 g;
glutamic acid 3.4 g;
isoleucine 3.4 g;
leucine, 4.7 g;
Lysine hydrochloride 6.8 g, which corresponds to the content of lysine 5.4 g;
methionine 3.4 g;
proline, 4.1 g;
serine 2.7 g;
tyrosine is 140 mg;
threonine, 3.4 g;
tryptophan 1.1 g;
phenylalanine 4.7 PM

Electrolytes: calcium chloride x 2H2O 590 mg, which corresponds to the contents of calcium chloride, 440 mg sodium glycerophosphate (anhydrous), 3 g of magnesium sulfate x 7H2O 2 g, which corresponds to the content of magnesium sulfate 960 mg of potassium chloride, 3.6 g sodium acetate x 3N2O 4.9 g, which corresponds content of sodium acetate, 2.9 PM

Equivalent content: Na + 64 mmol K + 48 mM Mg2 + 8 mM Ca2 + 4 mmol phosphate 20 mM sulphate 8 mmol Cl-93 mM CH3COO-78 mM nitrogen, 10.8 g osmolality around 1230 mOsm / kg water osmolarity of about 1060 mOsm / l, pH 5.4-5.8 energy : total 1900 ml kkal/2053 nonprotein 1600 kkal/2053 ml. Excipients: Water d / and.

Clinico-pharmacological group: The preparation for parenteral nutrition - a solution of amino acids, fats, carbohydrates, electrolytes.

Pharmacological action

The preparation for parenteral nutrition. The action of the drug is determined by the pharmacological activity of its components.

Vamin 1918 Novum intended for parenteral nutrition in patients with different pathologies with increased protein requirements, when enteral feeding is ineffective or impossible. Intralipid used for parenteral nutrition as a source of energy and essential fatty acids. Intralipid is shown in patients with deficiency of essential fatty acids, incapable of self-fill the normal balance of essential fatty acids by oral administration. Intralipid contains refined soybean oil, emulsified with purified egg phospholipids. The size of lipid globules and biological properties Intralipida similar to the characteristics of endogenous chylomicrons.

In contrast to chylomicrons Intralipid does not contain cholesterol esters and apolipoprotein B, and phospholipid content is higher. Dextrose (glucose) is an indispensable source of quick release energy required, including and metabolism of amino acids.

Pharmacokinetics

Intralipid is derived from the blood flow in the same way as the chylomicrons. Exogenous lipid particles are mainly hydrolyzed in the blood and trapped LDL-receptors in the liver and peripheral tissues. Elimination rate is determined by the composition of lipid particles, clinical condition and nutritional status of the patient, as well as the rate of infusion. Maximum ground clearance is equivalent Intralipida fasting triglycerides 3.8 +1.5 g / kg / day. Elimination rate and oxidation depend on the clinical condition of the patient: excretion and oxidation are accelerated in sepsis and after trauma, and, conversely, slowing renal failure and hypertriglyceridemia.

Pharmacokinetic characteristics of amino acids and electrolytes, introduced by i / v infusion, such as when entering a normal diet. However, the amino acid food proteins first enter the portal vein of the liver, and only then into the systemic circulation, whereas the amino acids introduced into the vein, directly into the systemic circulation.

Pharmacokinetic characteristics of dextrose (glucose), introduced by infusion, the same as when she entered with the usual food.

Statement
parenteral nutrition of adults and children aged 2 years and older, when oral or enteral nutrition is impossible, insufficient or contraindicated.

Dosage regimen

The drug is introduced into / in the drip, only the central vein. Infusion can continue as long as required by the clinical condition of the patient, based on the daily requirement of glucose, lipids and amino acids. Dose and infusion rate determined by the patient's ability to remove lipids and metabolize glucose. Kabiven center comes in bags in four sizes, designed for patients with normal, moderately increased or reduced demand for nutrients.

For a full parenteral nutrition may need to add vitamins, electrolytes and trace elements. The dose should be selected individually, and the choice of the bag should take into account the patient's condition, body weight and the need for nutrients.

In patients with obesity, the dose should be set on the basis of ideal body weight.

In patients with moderate or severe catabolic stress with or without malnutrition need for amino acids is 1-2 g / kg / day, about the need for nitrogen 0.15-0.3 g / kg / day. This corresponds to 27-40 ml Kabivena central to 1 kg of body weight per day.

Patients without catabolic stress the need for amino acids is 0.7-1.3 g / kg / day, equivalent to the need for nitrogen 0.1-0.2 g / kg / day. This corresponds to 19-38 ml Kabivena central to 1 kg of body weight per day. The maximum daily dose. Adults - 40 ml / kg / day. This is equal to 1 bag (maximum size - 2566 ml) for a patient with a body weight 64 kg, and ensures the supply of 1.3 g amino acids / kg / day (0.21 g nitrogen / kg / d), 31 kcal / kg / day, non-protein energy, 3.9 g glucose / kg / day and 1.6 g fat / kg / day. The maximum daily dose depends on the clinical condition of the patient and may vary.

For children aged 2-10 years infusion should be started with a low dose - 14-28 ml / kg. The dose should be increased to 10-15 ml / kg / day to a maximum of 40 ml / kg / day.

In children older than 10 years can apply the same dose as in adults. Rate of infusion rate of infusion should not exceed 2.6 ml / kg / h, which corresponds to the infusion rate of dextrose (glucose) 0.25 g / kg / h, amino acids 0.09 g / kg / h, and lipids 0.13 g / kg / h. The recommended duration of infusion Kabivena Central is 12-24 hours instruction on the use of three-chamber bag
Remove the outer package, tearing it in place of the notch and pulling it along the bag.
Thumb and index fingers of both hands firmly to take up sides over the middle of the bag retainer that separates chamber 1 and 2. Pull the walls of the bag in hand and fully open the lock.
Similarly, open the lock between chambers 2 and 3. Stir the contents, turning the bag several times.
If necessary, the introduction of additives (with known compatibility, for example, preparations of vitamins, trace elements) should wipe membrane inlet antiseptic.
Put the bag on the table, holding the base of the inlet, fully enter the needle through the center of the membrane and enter the supplement (with a known compatibility). Before the introduction of other additives and mix thoroughly, turning the sack a few times.
Remove the cap from the needle infusion system, holding the ring between thumb and forefinger and pulling the ring up. Infusion system to be used without access to air or to block access to the air system that can access the air.
Put the bag on a flat surface. Hold the bag outlet up fully enter the needle through the membrane, if necessary, turning and pushing her. To provide secure needle it should be implemented fully.
The bag should be hung on the rack and carry out the instructions to the infusion system and infusion pump.

Another way to open the latches: to put the bag on a flat surface and roll it from the pen until the latches will not engage. Stir the contents, turning the bag several times. Separate components of the introduction of individual cells of the central Kabivena technically impossible (except Intralipida), although each component of the central Kabivena - Vamin, Intralipid and dextrose (glucose) - can be used as separate products.

Side effect

Allergic reactions: anaphylactic reaction, fever, chills, tremors, skin rash, urticaria.
On the part of the respiratory system: changes in breathing (tachypnea).
Since the cardiovascular system: the reduction or increase blood pressure.
On the part of the digestive system: increased activity of liver enzymes, abdominal pain.
On the part of the hemopoietic system: hemolysis, reticulocytosis.

Local reactions: thrombophlebitis when infused into peripheral veins. Other: headache, priapism. With the right introduction of side effects developing extremely rare.

Contraindications
marked hyperlipidemia;
marked hepatic impairment;
expressed by the clotting of blood;
inborn errors of metabolism of amino acids;
renal failure, severe in the absence of hemodialysis or hemofiltration;
acute phase of shock;
hyperglycemia, which requires the introduction of insulin in a dose of more than 6 IU / h;
pathologically increased plasma concentration of any constituent of the preparation of electrolytes;
General contraindications to infusion therapy: acute pulmonary edema, hyperhydration, decompensated heart failure and hypotonic dehydration;
unstable states (including post-traumatic condition, uncompensated diabetes mellitus, myocardial infarction in the acute stage, decompensated metabolic acidosis, severe sepsis and hyperosmolar coma);
Hypersensitivity to egg or soy protein or to any subsidiary component of the drug.

Precautions should be used drug in violation of lipid metabolism due to renal failure, diabetes mellitus, pancreatitis, liver problems, hypothyroidism (with hypertriglyceridemia), or sepsis. With the introduction of central Kabivena patients with such disorders need careful control of the concentration of TG in plasma.

Pregnancy and lactation

Special Security Studies of the central Kabivena during pregnancy and lactation was conducted. Before the appointment of the central Kabivena during pregnancy and lactation should carefully evaluate the potential benefit of therapy for the mother and the potential risk to the fetus or infant.

Application for violations of liver function

Contraindicated in marked hepatic failure.

Application for violations of renal function

Contraindicated in renal failure, severe in the absence of hemodialysis or hemofiltration.

Cautions

Kabiven central osmolarity is 1060 mOsm / l and therefore not suitable for in / in the introduction of peripheral vein in adults and in children because of the risk of thrombosis.

When you enter the central Kabivena patients with impaired lipid metabolism due to renal failure, diabetes mellitus, pancreatitis, abnormal liver function, hypothyroidism (with hypertriglyceridemia), or sepsis necessarily requires careful control of the concentration of TG in plasma. In applying the drug should be monitored by the ability of lipid removal by measuring the concentration of TG in plasma 5-6 h after the last reception of fats. Fat overload syndrome may occur when the recommended rate of infusion if the patient's clinical condition is changing dramatically and have severe renal or hepatic insufficiency.

One should carefully calculate the amount of medication injected and adjust it according to the water balance and nutritional status of the patient. Each container is intended for single use. Marked disorders of electrolyte and water balance must be adjusted before the start of infusion. At the beginning of infusion required monitoring of patients. Since any infusion into the central vein is accompanied by an increased risk of infection during the catheter or the handling of them should abide by strict rules of asepsis to avoid infection.

Regularly check the concentration of glucose and electrolytes in blood plasma, as well as osmolarity, water balance, acid-base status and activity of liver enzymes. With prolonged administration of lipids should be monitored cellular composition of blood and blood clotting parameters. This preparation is a lack of vitamins and trace elements, so for a full parenteral nutrition must be administered separately.

To fill them recommended Vitalipid H adult or child Vitalipid N, Soluvit H Addamel N. When any signs and symptoms of allergic reactions infusion should be stopped immediately. The presence of lipids in the central Kabivene can alter the results of some laboratory tests (eg, the concentration of bilirubin, lactate dehydrogenase, hemoglobin oxygen saturation), if the blood sample was obtained until a sufficient removal of lipids from the bloodstream. The majority of patients entered lipids appear after 5-6 h. In / in the introduction of amino acids may be accompanied by increased renal excretion of trace elements, especially zinc.

Patients requiring long-term in / in nutrition, may need supplementation of trace elements. In patients with severely depleted the beginning of parenteral nutrition can cause a shift of water balance, leading to pulmonary edema and congestive heart failure.

In addition, within 24-48 h in blood plasma can see the decline of the concentration of potassium, phosphorus, magnesium and water-soluble vitamins. It is recommended to start parenteral nutrition slowly with careful monitoring and appropriate correction of fluid, electrolytes, vitamins and trace elements. Kabiven center should not be injected through a catheter and simultaneously with the blood or blood products because of the risk of psevdoagglyutinatsii.

Patients with hyperglycemia might need insulin. Venous catheter through which introduces complete parenteral nutrition, not recommended for use in / introduction of other fluids and medications. Any remainder of the open container must be destroyed.

Use in pediatrics

Kabiven center is intended primarily for patients older than 2 years.

In children under 2 years Kabiven central can only be used according to the life in the absence of special adapted amino acid solution containing taurine (Aminova infante). Premature infants and children with low birth weight may have impaired metabolism of fats. Should closely monitor the concentration of TG.

Overdose

Symptoms: due to violations of the ability of removing fat may develop fat overload syndrome - hyperlipidemia, fever, hepatosplenomegaly, anemia, leukopenia, thrombocytopenia, coagulopathy and coma. Treatment: the cessation of lipid infusion, symptomatic therapy.

Drug Interactions

Heparin in therapeutic doses causes a transient release of lipoprotein lipase into the bloodstream, which can result in the beginning to enhance lipolysis in the blood plasma, and then to a transient decrease in clearance of TG. Insulin may also affect the activity of lipase, but the data on the adverse impact of this factor on the therapeutic value of the drug available. Vitamin K1, contained in soybean oil, is an antagonist of coumarin derivatives, and therefore recommends careful monitoring of blood clotting in patients receiving these drugs.

Kabiven center can be mixed only with those drugs and the nutrient solution, which confirmed compatibility with, for example: Vitalipid H adult and children's Vitalipid N; Soluvit N; Addamel H; Dipeptiven. Mixing solutions should be carried out in aseptic conditions.

Terms and Conditions of storage

The drug should be stored out of reach of children at or above 25 ° C Do not freeze. Shelf life of the drug in the outer bag - 2 years. After the disclosure of fixatives and mixing three solutions to a mixture of compatible additives can be added through the inlet. After the disclosure of fixatives chemical and physical stability of the mixed content is stored in three chambers for 24 h at 25 ° C.

In order to ensure microbiological safety of the mixture should be used immediately after introduction of additives. If the mixture is not used immediately but subject to the introduction of aseptic additives emulsion mixture can be stored up to 6 days at 2 ° to 8 ° C, then the mixture should be used within 24 hours