Composition, form of production and packaging
Kabinen В® central is produced in a three-chamber bag and is presented in four volumes (1026 ml, 1540 ml, 2053 ml, 2566 ml).
A bag of 1026 ml contains:
Glucose 19% - 526 ml,
Vamin 18 Novum - 300 ml,
Intralipid 20% - 200 ml.
The energy value is 900 kcal.
Dextrose (glucose) 19% - a transparent solution, almost colorless, free of foreign particles.
Vamin 18 Novum is a clear solution, colorless or slightly yellowish, free of foreign particles.
Intralipid 20% - a homogeneous emulsion of white or white with a cream shade of color.
When mixing the contents of the three chambers, a white emulsion is formed.
Emulsion for infusions 1026 ml
soybean oil 40 g
dextrose monohydrate 110 g,
which corresponds to the content of dextrose anhydrous 100 g
L-alanine 4.8 g
L-arginine 3.4 g
L-aspartic acid 1 g
L-valine 2.2 g
L-Histidine 2 g
glycine (aminoacetic acid) 2.4 g
L-glutamic acid 1.7 g
L-isoleucine 1.7 g
L-leucine 2.4 g
L-lysine hydrochloride 3.4 g,
which corresponds to the content of lysine 2.7 g
L-Methionine 1.7 g
L-proline 2 g
L-Serine 1.4 g
L-Tyrosine 70 mg
L-threonine 1.7 g
L-tryptophan 570 mg
L-phenylalanine 2.4 g
calcium chloride dihydrate 290 mg,
which corresponds to the content of calcium chloride 220 mg
sodium glycerophosphate (anhydrous) 1.5 g
magnesium sulfate heptahydrate 990 mg,
which corresponds to the content of magnesium sulfate 480 mg
potassium chloride 1.8 g
sodium acetate trihydrate 2.5 g,
which corresponds to the content of sodium acetate 1.5 g
Including: amino acids 34 g nitrogen 5.4 g fats 40 g carbohydrates - dextrose (anhydrous) 100 g energy: total 900 kcal non-protein 800 kcal electrolytes: sodium 32 mmol potassium 24 mmol magnesium 4 mmol calcium 2 mmol phosphate 10 mmol sulfate 4 mmol chloride 46 mmol acetate 39 mmol osmolality about 1230 mOsmol / kg water osmolarity about 1060 mOsmol / l
Excipients: egg yolk phospholipids - 2.4 g, glycerol (anhydrous) - 4.4 g, glacial acetic acid - qs for pH correction, sodium hydroxide - qs for pH correction, water d / u - up to 1026 ml.
1026 ml - plastic three-chamber containers "Biophin" (1) with antioxidant - plastic bags (2) - cardboard boxes.
1026 ml - plastic three-chamber containers "Biophin" (1) with antioxidant - plastic bags (3) - cardboard boxes.
1026 ml - plastic three-chamber containers "Biophin" (1) with antioxidant - plastic bags (4) - cardboard boxes.
A bag of 1540 ml contains:
Glucose 19% - 790 ml,
Vamin 18 Novum - 450 ml,
Intralipid 20% - 300 ml.
The energy value is 1400 kcal.
Emulsion for infusions 1540 ml
soybean oil 60 g
dextrose (glucose) monohydrate 165 g,
which corresponds to the content of dextrose anhydrous 150 g
L-alanine 7.2 g
L-arginine 5.1 g
L-aspartic acid 1.5 g
L-Valine 3.3 g
L-Histidine 3.1 g
glycine (aminoacetic acid) 3.6 g
L-glutamic acid 2.5 g
L-isoleucine 2.5 g
L-leucine 3.6 g
L-lysine hydrochloride 5.1 g,
which corresponds to the content of lysine 4.1 g
L-Methionine 2.5 g
L-proline 3.1 g
L-Serine 2 g
L-Tyrosine 100 mg
L-threonine 2.5 g
L-tryptophan 860 mg
L-phenylalanine 3.6 g
calcium chloride dihydrate 440 mg,
which corresponds to the content of calcium chloride 330 mg
sodium glycerophosphate (anhydrous) 2.3 g
magnesium sulfate heptahydrate 1.5 g,
which corresponds to the content of magnesium sulfate 720 mg
potassium chloride 2.7 g
sodium acetate trihydrate 3.7 g,
which corresponds to the content of sodium acetate 2.2 g
Including: amino acids 51 g nitrogen 8.1 g fat 60 g carbohydrate dextrose 150 g energy: total 1400 kcal non-protein 1200 kcal electrolytes: sodium 48 mmol potassium 36 mmol magnesium 6 mmol calcium 3 mmol phosphate 15 mmol sulfate 6 mmol chloride 70 mmol acetate 58 mmol osmolality about 1230 mosmol / kg water osmolarity about 1060 mosmol / l
Excipients: egg yolk phospholipids - 3.6 g, glycerol (anhydrous) - 6.6 g, acetic acid ice - qs for pH correction, sodium hydroxide - qs for pH correction, water d / u - up to 1540 ml.
1540 ml - plastic three-chamber containers "Biophin" (1) with antioxidant - plastic bags (2) - cardboard boxes.
1540 ml - plastic three-chamber containers "Biophin" (1) with antioxidant - plastic bags (3) - cardboard boxes.
1540 ml - plastic three-chamber containers "Biophin" (1) with antioxidant - plastic bags (4) - cardboard boxes.
The 2053 ml bag contains:
Glucose 19% - 1053 ml,
Vamin 18 Novum - 600 ml,
Intralipid 20% - 400 ml.
The energy value is 1900 kcal.
Emulsion for infusions 2053 ml
soybean oil 80 g
dextrose (glucose) monohydrate 220 g,
which corresponds to the content of dextrose anhydrous 200 g
L-alanine 9.6 g
L-arginine 6.8 g
L-aspartic acid 2 g
L-valine 4.4 g
L-Histidine 4.1 g
glycine (aminoacetic acid) 4.7 g
L-glutamic acid 3.4 g
L-isoleucine 3.4 g
L-leucine 4.7 g
L-lysine hydrochloride 6.8 g,
which corresponds to the content of lysine 5.4 g
L-Methionine 3.4 g
L-proline 4.1 g
L-Serine 2.7 g
L-tyrosine 140 mg
L-threonine 3.4 g
L-tryptophan 1.1 g
L-phenylalanine 4.7 g
calcium chloride dihydrate 590 mg,
which corresponds to the content of calcium chloride 440 mg
sodium glycerophosphate (anhydrous) 3 g
magnesium sulfate heptahydrate 2 g,
which corresponds to the content of magnesium sulfate 960 mg
potassium chloride 3.6 g
sodium acetate trihydrate 4.9 g,
which corresponds to the content of sodium acetate 2.9 g
Including: amino acids 68 g nitrogen 10.8 g fats 80 g carbohydrates - dextrose (anhydrous) 200 g energy: total 1900 kcal non-protein 1600 kcal electrolytes: sodium 64 mmol potassium 48 mmol magnesium 8 mmol calcium 4 mmol phosphate 20 mmol sulfate 8 mmol chloride 93 mmol acetate 78 mmol osmolality about 1230 mosmol / kg water osmolarity about 1060 mosmol / l
Excipients: egg yolk phospholipids - 4.8 g, glycerol (anhydrous) - 8.8 g, acetic acid ice - qs for pH correction, sodium hydroxide - qs for pH correction, water d / u - up to 2053 ml.
2053 ml - plastic three-chamber containers "Biophin" (1) with antioxidant - plastic bags (2) - cardboard boxes.
2053 ml - plastic three-chamber containers "Biophin" (1) with antioxidant - plastic bags (3) - cardboard boxes.
2053 ml - plastic three-chamber containers "Biophin" (1) with antioxidant - plastic bags (4) - cardboard boxes.
A 2566 ml bag contains:
Glucose 19% - 1316 ml,
Vamin 18 Novum - 750 ml,
Intralipid 20% - 600 ml.
The energy value is 2300 kcal.
Emulsion for infusion 2566 ml
soybean oil 100 g
dextrose (glucose) monohydrate 275 g,
which corresponds to the content of dextrose anhydrous 250 g
L-alanine 12 g
L-arginine 8.5 g
L-aspartic acid 2.6 g
L-Valine 5.5 g
L-Histidine 5.1 g
glycine (aminoacetic acid) 5.9 g
L-glutamic acid 4.2 g
L-isoleucine 4.2 g
L-Leucine 5.9 g
L-lysine hydrochloride 8.5 g,
which corresponds to the content of lysine 6.8 g
L-Methionine 4.2 g
L-proline 5.1 g
L-serine 3.4 g
L-Tyrosine 170 mg
L-threonine 4.2 g
L-tryptophan 1.4 g
L-phenylalanine 5.9 g
calcium chloride dihydrate 740 mg,
which corresponds to the content of calcium chloride 560 mg
Sodium glycerophosphate (anhydrous) 3.8 g
magnesium sulfate heptahydrate 2.5 g,
which corresponds to the content of magnesium sulfate 1.2 g
potassium chloride 4.5 g
sodium acetate trihydrate 6.1 g,
which corresponds to the content of sodium acetate 3.7 g
Including: amino acids 85 g nitrogen 13.5 g fats 100 g carbohydrates - dextrose (anhydrous) 250 g energy: total 2300 kcal non-protein 2000 kcal electrolytes: sodium 80 mmol potassium 60 mmol magnesium 10 mmol calcium 5 mmol phosphate 25 mmol sulfate 10 mmol chloride 116 mmol acetate 97 mmol osmolality about 1230 mosmol / kg water osmolarity about 1060 mosmol / l
Excipients: egg yolk phospholipids - 6 g, glycerol (anhydrous) - 10 g, glacial acetic acid - qs for correction pH, sodium hydroxide - qs for pH correction, water d / u - up to 2566 ml.
2566 ml - plastic three-chamber containers "Biophin" (1) with antioxidant - plastic bags (2) - cardboard boxes.
2566 ml - plastic three-chamber containers "Biophin" (1) with antioxidant - plastic bags (3) - cardboard boxes.
2566 ml - plastic three-chamber containers "Biofin" (1) with antioxidant - plastic bags (4) - cardboard boxes.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2008.
PHARMACHOLOGIC EFFECT
The 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 increased protein requirement, 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 deficiency of essential fatty acids, unable to independently replenish the normal balance of essential fatty acids by ingestion. Intralipid contains purified soybean oil, emulsified with purified egg phospholipids. Dimensions of lipid globules and biological properties of Intralipid are similar to those of endogenous chylomicrons. In contrast to chylomicrons, Intralipid does not contain cholesterol and apolipoprotein esters, and its phospholipid content is higher.
Dextrose (glucose) is an indispensable source of fast-releasing energy, necessary, incl. and for the metabolism of amino acids.
PHARMACOKINETICS
Intralipid is excreted from the bloodstream in the same way as chylomicra. Exogenous lipid particles are mainly hydrolyzed in the blood and captured by LDL receptors in the liver and peripheral tissues. The rate of excretion is determined by the composition of the lipid particles, the clinical condition and nutritional status of the patient, and the rate of infusion. The maximum clearance of Intralipida on an empty stomach is equivalent to 3.8 + 1.5 g of triglycerides / kg / day. Rates of excretion and oxidation depend on the clinical condition of the patient: excretion and oxidation are accelerated in sepsis and after trauma, and, conversely, slow down in renal failure and hypertriglyceridemia.
The pharmacokinetic characteristics of amino acids and electrolytes administered by intravenous infusion are the same as when administered with normal food. However, the amino acids of food proteins first enter the portal vein of the liver, and only then into the systemic bloodstream, while the amino acids introduced into the vein enter the systemic circulation directly.
The pharmacokinetic characteristics of dextrose (glucose) administered by infusion are the same as when administered with normal food.
INDICATIONS
- parenteral nutrition of adults and children aged 2 years and older, when oral or enteral nutrition is impossible, insufficient or contraindicated.
DOSING MODE
The drug is injected intravenously, only into the central veins. Infusion can be continued for as long as the clinical state of the patient requires, based on the daily requirement for glucose, lipids and amino acids. The dose of the drug and the speed of infusion are determined by the ability of the patient's body to excrete lipids and metabolize glucose.
Kabiven central is available in bags of four sizes, intended for patients with normal, moderately elevated or reduced nutrient requirements. To conduct complete parenteral nutrition may require the addition of vitamins, electrolytes and trace elements.
The dose should be selected individually, and when choosing the volume of the bag, the patient's condition, body weight and nutrient requirements should be taken into account.
In patients with obesity, the dose should be determined based on the ideal body weight.
In patients with moderate or severe catabolic stress with or without malnutrition, the requirement for amino acids is 1-2 g / kg / day, which roughly corresponds to the requirement for nitrogen 0.15-0.3 g / kg / day. This corresponds to 27-40 ml of Kabivena central per 1 kg of body weight per day.
In patients without catabolic stress, the need for amino acids is 0.7-1.3 g / kg / day, which is equal to the need for nitrogen 0.1-0.2 g / kg / day. This corresponds to 19-38 ml of Kabivena central per 1 kg of body weight per day.
The maximum daily dose
Adults - 40 ml / kg / day. This is 1 bag (the largest size is 2566 ml) for a patient weighing 64 kg and provides the intake 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 fats / kg / day.
The maximum daily dose depends on the clinical condition of the patient and may vary.
In infants aged 2-10 years, infusion of the drug should begin with a low dose of 14-28 ml / kg. The dose should be increased by 10-15 ml / kg / day, to a maximum of 40 ml / kg / day.
In children older than 10 years, you can use the same doses as in adults.
Infusion rate
The infusion rate should not exceed 2.6 ml / kg / h, which corresponds to the rate of infusion 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.
Instructions for using a three-chamber bag
- Remove the outer bag by tearing it in place of the notch and pulling it along the bag.
- With the thumb and forefinger of both hands, tightly grasp the side walls of the bag over the middle of the lock that separates the chambers 1 and 2. Pull the sides of the bag to the sides and open the latch completely.
- In the same way, open the latch between chambers 2 and 3. Mix the contents by turning the bag several times.
- If it is necessary to add (with known compatibility, for example, preparations of vitamins, microelements), it is necessary to wipe the membrane of the inlet with an antiseptic.
- Put the bag on the table; holding the base of the inlet, completely insert the needle through the center of the membrane and introduce an additive (with known compatibility). Before adding another additive, carefully mix the contents, turning the bag several times.
- Remove the cap from the needle of the infusion system by grasping the ring with your thumb and forefinger and pulling the ring upwards. The infusion system should be used without air access or shut off air access on a system that has air access.
- Put the bag on a flat surface. While holding the bag with the outlet hole up, completely insert the needle through the membrane, if necessary turn and push it. To secure the needle securely, it must be fully inserted.
- The bag should be hung on the rack and follow instructions for the infusion system and the infusion pump.
Another way to open the latches is to put the bag on a flat surface and fold it on the handle side until the latches open. Thoroughly mix the contents by turning the bag several times.
Separate introduction of components from separate Kabini central chambers is technically impossible (with the exception of Intralipid), although each component of the Kabini central - Vamin, Intralipid and dextrose (glucose) solution - can be used as separate preparations.
SIDE EFFECT
Allergic reactions: anaphylactic reaction, fever, chills, tremors, skin rashes, urticaria.
On the part of the respiratory system: changes in breathing (tachypnea).
From the cardiovascular system: a decrease or increase in blood pressure.
On the part of the digestive system: increased activity of liver enzymes, abdominal pain.
From the hemopoietic system: hemolysis, reticulocytosis.
Local reactions: thrombophlebitis with infusion into peripheral veins.
Other: headache, priapism.
With proper administration, side effects develop extremely rarely.
CONTRAINDICATIONS
- severe hyperlipidemia;
- severe hepatic impairment;
- severe blood clotting disorders;
- congenital disorders of amino acid metabolism;
- renal failure of severe degree 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 U / 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;
- unstable conditions (including post-traumatic state, uncompensated diabetes mellitus, acute myocardial infarction, decompensated metabolic acidosis, severe sepsis and hyperosmolar coma);
- Hypersensitivity to egg or soy protein or to any auxiliary component of the drug.
Caution should be applied to the drug in violation of the metabolism of lipids due to renal failure, diabetes, pancreatitis, liver dysfunction, hypothyroidism (with hypertriglyceridemia) or sepsis. When Kabiven is administered central to patients with such disorders, careful monitoring of TG concentration in the blood plasma is essential.
PREGNANCY AND LACTATION
Special studies of the safety of Kabiven's use during pregnancy and lactation were not carried out. Prior to the appointment of Kabini central during pregnancy and during lactation, the potential benefits of therapy for the mother and the possible risk to the fetus or infant should be carefully evaluated.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated in renal failure of severe degree in the absence of hemodialysis or hemofiltration.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated in severe hepatic insufficiency.
SPECIAL INSTRUCTIONS
Kabiven central has an osmolality of 1060 mOsm / l and is therefore not suitable for intravenous administration in peripheral veins in both adults and children because of the risk of developing thrombophlebitis.
When administered central Kabivena patients with impaired lipid metabolism due to renal failure, diabetes, pancreatitis, liver dysfunction, hypothyroidism (with hypertriglyceridemia) or sepsis need careful control of the concentration of TG in the blood plasma.
In applying the drug to be monitored by the ability of lipid removal by measuring the concentration of TG in the plasma after 5-6 hours after the last dose of fat.
Fat overload syndrome may occur when the recommended infusion rate in the event that the patient's clinical condition changes dramatically and developed severe renal or hepatic insufficiency.
It should be carefully calculate the amount of drug administered and adjust it according to the water balance and the condition of the patient's diet. Each container is designed for a single use.
Expressed of electrolyte and water balance must be adjusted before the start of infusion.
At the beginning of infusion monitoring of patients required. Since any infusion into a central vein is accompanied by an increased risk of infection, during insertion of the catheter or the handling of them should observe strict aseptic technique to prevent infection.
It is necessary to regularly check the concentration of glucose and electrolytes in the blood plasma, and osmolarity, water balance, acid-base status and liver enzyme.
With prolonged administration of lipids should be monitored cellular composition of blood and blood clotting.
In this preparation no vitamins and trace elements, so they should be administered further for total parenteral nutrition. To fill them recommended Vitalipid H adult or child Vitalipid N, N Soluvit Addamel N.
When any signs and symptoms of allergic reactions, the infusion should be discontinued immediately.
The presence of the lipids in the central Kabivene may alter the results of some laboratory tests (e.g., bilirubin, lactate dehydrogenase, hemoglobin oxygen saturation) if the blood sample was obtained prior to sufficient removal of lipids from the blood stream. The majority of patients entered lipids appear after 5-6 hours.
In / in the introduction of the amino acids may be accompanied by increased renal excretion of trace elements, particularly zinc. Patients requiring long-term in / in nutrition, may require supplementation of trace elements.
In severely malnourished patients the beginning of parenteral nutrition can cause a shift of water balance, leading to pulmonary edema and congestive heart failure. Furthermore, for 24-48 hours in the blood plasma can be observed decrease in 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 blood or blood products because of the risk psevdoagglyutinatsii.
Patients with hyperglycemia may require administration of insulin.
Venous catheter which is introduced through total parenteral nutrition is not recommended for use in / introduction of other fluids and drugs.
Any remainder of the open container must be disposed of
Use in pediatrics
Kabiven center is designed primarily for patients older than 2 years. In children under 2 years Kabiven center can be used only for health in the absence of special adapted amino acid solution containing taurine (amine Infant).
Premature babies and babies with low birth weight may have impaired metabolism of fats. You should carefully monitor the concentration of triglycerides.
OVERDOSE
Symptoms due to impaired ability of removing fat may develop fat overload syndrome - hyperlipidemia, fever, hepatosplenomegaly, anemia, leukopenia, thrombocytopenia, coagulopathy and coma.
Treatment: cessation of the lipid infusion, symptomatic therapy.
DRUG INTERACTION
Heparin in therapeutic doses causes a transient release of lipoprotein lipase in blood flow, which may lead to early enhancement lipolysis in plasma and then to a transient decrease in TG clearance.
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 K 1 , 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 center may be mixed only with those medicaments and nutrient solutions for which confirmed compatibility with, for example: Vitalipid H H Vitalipid adult and children; Soluvit H; Addamel H; Dipeptiven. Mixing of the solutions should be conducted under aseptic conditions.
TERMS OF RELEASE FROM PHARMACY
The drug is released only for hospitals.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in reach of children at a temperature not higher than 25 В° C; Do not freeze. Shelf-life of the drug in the outer bag - 2 years.
After the latches opening and mixing the three solutions can be added to a mixture of compatible additives via inlet. After opening clamps chemical and physical stability of the mixed contents of the three chambers is maintained for 24 hours at 25 В° C. The mixture should be used immediately after the introduction of additives to ensure microbiological safety. If the mixture is not used immediately, the subject additives of asepsis when administered emulsion mixture can be stored up to 6 days at a temperature of from 2 В° to 8 В° C, then the mixture should be used within 24 hours.
