Composition, form of production and packaging
KabivenВ® peripheral is released in a three-chamber bag and is presented in three volumes (1440 ml, 1920 ml, 2400 ml).
A bag of 1440 ml contains:
Glucose 11% - 885 ml,
Vamin 18 Novum - 300 ml,
Intralipid 20% - 255 ml.
The energy value is 1000 kcal.
Dextrose (glucose) 11% - a clear 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 infusion 1440 ml
soybean oil 51 g
dextrose (glucose) monohydrate 107 g,
which corresponds to the content of dextrose anhydrous 97 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 69 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 51 g carbohydrates - dextrose (anhydrous) 97 g energy: only 1000 kcal non-protein 900 kcal electrolytes: sodium 32 mmol potassium 24 mmol magnesium 4 mmol calcium 2 mmol phosphate 11 mmol sulfate 4 mmol chloride 47 mmol acetate 39 mmol osmolality about 830 mOsmol / kg water osmolarity about 750 mOsmol / l
Excipients: egg yolk phospholipids - 3.1 g, glycerol (anhydrous) - 5.6 g, glacial acetic acid - qs for pH correction, sodium hydroxide - qs for pH correction, water d / and - up to 1440 ml.
1440 ml - plastic three-chamber containers "Biophin" (1) with antioxidant - plastic bags (2) - cardboard boxes.
1440 ml - plastic three-chamber containers "Biophin" (1) with antioxidant - plastic bags (3) - cardboard boxes.
1440 ml - plastic three-chamber containers "Biophin" (1) with antioxidant - plastic bags (4) - cardboard boxes.
A bag of 1920 ml contains:
Glucose 11% - 1180 ml,
Vamin 18 Novum - 400 ml,
Intralipid 20% - 340 ml.
The energy value is 1400 kcal.
Emulsion for infusions of 1920 ml
soybean oil 68 g
dextrose (glucose) monohydrate 143 g,
which corresponds to the content of dextrose anhydrous 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,
which corresponds to the content of lysine 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 the content of sodium acetate 2 g
Including: amino acids 45 g nitrogen 7.2 g fats 68 g carbohydrates dextrose (anhydrous) 130 g energy: total 1400 kcal non-protein 1200 kcal electrolytes: sodium 43 mmol potassium 32 mmol magnesium 5.3 mmol calcium 2.7 mmol phosphate 14 mmol sulfate 5.3 mmol chloride 62 mmol acetate 52 mmol osmolality about 830 mOsmol / kg water osmolarity about 750 mOsmol / l
Excipients: egg yolk phospholipids - 4.1 g, glycerol (anhydrous) - 7.5 g, glacial acetic acid - qs for pH correction, sodium hydroxide - qs for pH correction, water d / u - up to 1920 ml.
1920 ml - plastic three-chamber containers "Biophin" (1) with antioxidant - plastic bags (2) - cardboard boxes.
1920 ml - plastic containers three-chamber "Biophin" (1) with antioxidant - plastic bags (3) - cardboard boxes.
1920 ml - plastic three-chamber containers "Biophin" (1) with antioxidant - plastic bags (4) - cardboard boxes.
A 2400 ml bag contains:
Glucose 11% - 1475 ml,
Vamin 18 Novum - 500 ml,
Intralipid 20% - 425 ml.
The energy value is 1700 kcal.
Emulsion for infusions 2400 ml
soybean oil 85 g
dextrose (glucose) monohydrate 178 g,
which corresponds to the content of dextrose anhydrous 162 g
L-alanine 8 g
L-arginine 5.6 g
L-aspartic acid 1.7 g
L-Valine 3.6 g
L-Histidine 3.4 g
glycine (aminoacetic acid) 4 g
L-glutamic acid 2.8 g
L-isoleucine 2.8 g
L-leucine 4 g
L-lysine hydrochloride 5.6 g,
which corresponds to the content of lysine 4.5 g
L-Methionine 2.8 g
L-proline 3.4 g
L-serine 2.2 g
L-tyrosine 120 mg
L-threonine 2.8 g
L-tryptophan 950 mg
L-phenylalanine 4 g
calcium chloride dihydrate 490 mg,
which corresponds to a calcium chloride content of 370 mg
Sodium glycerophosphate (anhydrous) 2.5 g
magnesium sulfate heptahydrate 1.6 g,
which corresponds to the content of magnesium sulfate 800 mg
potassium chloride 3 g
sodium acetate trihydrate 4.1 g,
which corresponds to the content of sodium acetate 2.4 g
Including: amino acids 57 g nitrogen 9 g fat 85 g carbohydrates dextrose (anhydrous) 162 g energy: total 1700 kcal non-protein 1500 kcal electrolytes: sodium 53 mmol potassium 40 mmol magnesium 6.7 mmol calcium 3.3 mmol phosphate 18 mmol sulfate 6.7 mmol chloride 78 mmol acetate 65 mmol osmolality about 830 mOsmol / kg water osmolarity about 750 mOsmol / l
Excipients: egg yolk phospholipids - 5.1 g, glycerol (anhydrous) - 9.4 g, glacial acetic acid - qs for pH correction, sodium hydroxide - qs for pH correction, water d / u - up to 2400 ml.
2400 ml - plastic three-chamber containers "Biophin" (1) with antioxidant - plastic bags (2) - cardboard boxes.
2400 ml - plastic three-chamber containers "Biophin" (1) with antioxidant - plastic bags (3) - cardboard boxes.
2400 ml - plastic three-chamber containers "Biophin" (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
Means 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.
With the simultaneous infusion of a solution of dextrose and lipid emulsion, the risk of thrombophlebitis (due to decreased osmolarity of dextrose during dilution) is reduced, which always exists when hypertensive solutions are infused into the peripheral veins.
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 / drip.
The peripheral cabillum has an osmolality of 750 mOsm / l, and therefore the drug can be administered to adults and children in peripheral or 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 peripheral is available in bags of three 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. The energy requirement is 30-50 kcal / kg / day. This corresponds to 40 ml / kg / day.
In patients without catabolic stress, the requirement for amino acids 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.
The maximum daily dose
Adults - 40 ml / kg / day. This is 1 bag of the largest size for a patient weighing 64 kg and provides 0.96 g of amino acids / kg / day (0.16 g nitrogen / kg / day), 25 kcal / kg / day of non-protein energy, 2.7 grams of dextrose / kg / day and 1.4 g lipids / kg / day.
In infants aged 2-10 years, infusion of the drug should be started with a low dose (14-28 ml / kg, which corresponds to the daily intake of fats, amino acids and glucose, respectively 0.49-0.98 g / kg, 0.34-0.67 g / kg and 0.95- 1.9 g / kg), and the dose should be increased at 10-15 ml / kg / day, maximum to 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 3.7 ml / kg / h, which corresponds to a dose of dextrose, amino acids and lipids, respectively 0.25 g / kg / h, 0.09 g / kg / h and 0.13 g / kg / h.
The recommended duration of infusion of Kabiven peripheral is 12-24 h.
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 you need to add (with known compatibility, for example, preparations of vitamins, microelements), 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.
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's peripheral is administered to patients with such disorders, careful monitoring of the TG concentration in the blood plasma is essential.
PREGNANCY AND LACTATION
Special studies of the safety of Kabiven's peripheral use during pregnancy and lactation were not conducted. Before the appointment of Kabiven peripheral during pregnancy and during lactation, the potential benefit of therapy for the mother and the possible risk to the fetus or infant should be carefully evaluated.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindications: severe renal failure in the absence of hemodialysis or hemofiltration
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindications: severe hepatic impairment;
SPECIAL INSTRUCTIONS
When using the drug should monitor the ability to remove lipids by measuring the level of TG in the blood plasma after 5-6 hours after the last intake of fats.
Concentration of TG in blood plasma during infusion should not exceed 3 mmol / l.
The fat overload syndrome can be observed at the recommended infusion rate if the patient changes the clinical condition dramatically and develops severe renal or hepatic insufficiency.
Care should be taken to calculate the amount of the drug administered, which should be adjusted in accordance with the water balance and nutritional status of the patient. Each container is designed for single use.
Significant disturbances of the electrolyte and water balance should be adjusted before the infusion.
At the beginning of the infusion, observation of the patient is required. Since any infusion into the central vein is accompanied by an increased risk of infection, strict aseptic rules should be observed during insertion or manipulation of the catheter to avoid infection.
It is necessary to regularly monitor the concentrations of glucose and electrolytes in the blood plasma, as well as plasma osmolality, water balance, KChR and liver enzyme activity.
With prolonged administration of lipids, it is necessary to control the cellular composition of blood and blood coagulation.
Patients with renal insufficiency should carefully monitor the balance of phosphates and potassium to avoid the development of hyperphosphataemia and hyperkalemia.
The number of additional electrolytes should be determined by regularly monitoring their concentration, taking into account the clinical condition of the patient.
In this preparation there are no vitamins and trace elements. For their replenishment, it is recommended to use Vitalipid N adult or Vitalipid N children, Soluwit N, Addamel N.
When any signs and symptoms of allergic reactions, the infusion should be discontinued immediately.
The presence of the lipids in the circumferential Kabivene may alter the results of some laboratory tests (e.g., bilirubin, LDH activity, oxygen saturation of hemoglobin) 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 Peripheral should not be administered simultaneously through a single catheter with blood or blood products.
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 peripheral is intended primarily for patients older than 2 years. In children under 2 years Kabiven peripheral can be used only for health reasons, in the absence of special adapted amino acid solution containing taurine (amine Infante). 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
At therapeutic doses of heparin causes a transient release of lipoprotein lipase in blood flow, which may lead initially to increased lipolysis in plasma and then to a transient decrease in TG clearance.
Insulin may also affect the activity of lipase, but data on its adverse effects on the therapeutic efficacy 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 peripheral 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, it is subject when administered aseptic additives 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.
