Кабивен® central

General characteristics. Structure:

Active ingredients: 60 g of oil of soybeans, 165 g of a dextrose (glucose) monohydrate that corresponds to 150 g of a dextrose of anhydrous, 7,2 g of L-alanine, 5,1 g of L-arginine, 1,5 g of L-aspartic acid, 3,3 g of L-valine, 3,1 g of a L-histidine, 3,6 g of glycine, 2,5 g of L-glutaminic acid, 2,5 g of L-izoleytsina, 3,6 g of a L-leucine, 5,1 g of a L-lysine of a hydrochloride that corresponds 4,1 g of a lysine, 2,5 g of L-methionine, 3,1 g of L-proline, 2 g of L-serine, 100 mg of L-tyrosine, 2,5 g of L-threonine, 860 g of L-tryptophane, 3,6 g of L-phenylalanine, 440 mg of Calcii chloridum of a dihydrate that corresponds 330 mg of Calcii chloridum, 2,3 mg of sodium glycerophosphate (anhydrous), 1,5 g a heptahydrate sulfate agniya that corresponds to 720 mg of magnesium of sulfate, 2,7 g of potassium of chloride, 3,7 g of sodium of acetate trihydrate that there correspond 2,2 sodium of acetate.

 Including: 51 g минокислот, 8,1 g of nitrogen, 60 g of fats, 150 g of carbohydrates; energy: in total - 1400 kcal / 1540 ml, nonprotein - 1200 kcal / 1540 ml; 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 ¼«ß¼«½ý/kg waters, smolyarnost about 1060 ¼«ß¼«½ý/l.

Excipients: phospholipids of an egg yolk, глицерол (anhydrous), acetic acid ice - q.s. for correction pH, sodium hydroxide - q.s. for correction pH, water for injections.

Pharmacological properties:

Pharmacodynamics. Drug for parenteral food. Effect of drug is defined by pharmacological activity of its components.

Vamin 18 Novum is intended for parenteral food of patients with various pathology with the increased need for protein when the enteroalimentation is inefficient or it is impossible.

Intralipid apply to parenteral food as an energy source and irreplaceable fatty acids. Intralipid is shown to patients with the deficit of irreplaceable fatty acids incapable of independent completion of normal balance of essential fatty acids by intake. Intralipid contains the purified soy oil emulsified with the purified egg phospholipids. The sizes lipidic глобул and biological properties of Intralipid are similar to characteristics of endogenous chylomicrons. Unlike chylomicrons Intralipid does not contain ethers of cholesterol and apolipoprotein, and the content of phospholipids in it is higher.

Dextrose (glucose) is an irreplaceable source of quickly released energy, necessary, including and for metabolism of amino acids.

Pharmacokinetics. Intralipid is brought from a blood-groove in the same way, as chylomicrons. Exogenous particles of lipids are generally hydrolyzed in blood and taken LPNP-receptors in a liver and peripheral fabrics. Speed of removal is defined by structure of lipidic particles, a clinical condition and a condition of food of the patient, and also infusion speed. The maximum clearance of Intralipid is on an empty stomach equivalent to 3.8+1.5 g of triglycerides/kg/days. Speeds of removal and oxidation depend on a clinical condition of the patient: removal and oxidation accelerate at sepsis and after an injury, and, on the contrary, are slowed down at a renal failure and a gipertriglitseridemiya.

Pharmacokinetic characteristics of the amino acids and electrolytes entered in the way in/in infusions, same as at their receipt with usual food. However amino acids of proteins of food at first get into a portal vein of a liver, and only then in a system blood stream while the amino acids entered into a vein get directly to a system blood stream.

Pharmacokinetic characteristics of a dextrose (glucose) entered by infusion, same as at its receipt with usual food.

Indications to use:

— parenteral food of adults and children at the age of 2 years is also more senior when peroral or the enteroalimentation is impossible, there is not enough or contraindicated.

Route of administration and doses:

The drug is administered in/in kapelno, only in the central veins. Infusion it is possible to continue so much time how many it demands a clinical condition of the patient, proceeding from the daily need for glucose, lipids and amino acids. The dose of drug and speed of infusion are defined by ability of an organism of the patient to remove lipids and to metabolize glucose.

Kabiven central is issued in bags of four sizes intended for patients with the normal, moderately increased or reduced need for nutrients. For carrying out full parenteral food addition of vitamins, electrolytes and microelements can be required.

The dose should be selected individually, and at the choice of volume of a bag it is necessary to consider a condition of the patient, body weight and the need for nutrients.

At patients with obesity the dose should be established, proceeding from ideal body weight.

At patients with a moderate or heavy catabolic stress with or without insufficiency of food the need for amino acids makes 1-2 g/kg/days that approximately corresponds to the need for nitrogen of 0.15-0.3 g/kg/days. It corresponds to 27-40 ml of Kabiven central on 1 kg of body weight a day.

At patients without catabolic stress the need for amino acids makes 0.7-1.3 g/kg/days that is equal to the need for nitrogen of 0.1-0.2 g/kg/days. It corresponds to 19-38 ml of Kabiven central on 1 kg of body weight a day.

Maximum daily dose. Adult - 40 ml/kg/days. It is equal to 1 bag (the largest size - 2566 ml) for the patient with the body weight of 64 kg and provides receipt of 1.3 g of amino acids/kg/days (0.21 g of nitrogen/kg/days), 31 kcal/kg/days of nonprotein energy, 3.9 g of glucose/kg/days and 1.6 g of fats/kg/days.

The maximum daily dose depends on a clinical condition of the patient and can change.

At children at the age of 2-10 years infusion of drug should be begun with a low dose - 14-28 ml/kg. It is necessary to increase a dose on 10-15 ml/kg/days, as much as possible to 40 ml/kg/days.

At children 10 years are more senior it is possible to apply the same doses, as well as at adults.

Infusion speed. Speed of infusion should not exceed 2.6 ml/kg/h that corresponds to the speed of infusion of a dextrose (glucose) of 0.25 g/kg/h, amino acids of 0.09 g/kg/h and lipids of 0.13 g/kg/h.

The recommended duration of infusion of Kabiven central makes 12-24 h.

Instruction for use of a three-chambered bag:

— To remove an outside package, having broken off it in the place of a cut and having pulled it along a bag.

— Big and index fingers of both hands it is dense to undertake bag sidewalls over the middle of the fixer dividing cameras 1 and 2. To pull bag walls in the parties and to completely open the fixer.

— To similarly open the fixer between cameras 2 and 3. To mix contents, having turned a bag several times.

— In need of administration of additive (with the known compatibility, for example, drugs of vitamins, microelements) should be wiped a membrane of inlet opening with an antiseptic agent.

— To put a bag on a table; holding the basis of inlet opening, to completely enter a needle through the center of a membrane and to enter additive (with the known compatibility). Before administration of other additive carefully to mix contents, having turned a bag several times.

— To remove a cap from a needle of infusional system, having undertaken a ring big and index fingers and having pulled a ring up. The infusional system should be used without access of air or to block access of air on the system having air access.

— To put a bag on a flat surface. Holding a bag outlet opening up, to completely enter a needle through a membrane, if necessary turning and pushing it. For reliable fixing of a needle it has to be entered completely.

— The bag should be hung up on a rack and to carry out instructions to infusional system and the infusional pump.

Other way of opening of fixers: to put a bag on a flat surface and to curtail it from the handle until fixers reveal. To carefully mix contents, having turned a bag several times.

Separate introduction of components from separate cameras of Kabiven central is technically impossible (except for Intralipid) though each component of Kabiven central - Vamin, Intralipid and solution of a dextrose (glucose) - can be applied in the form of separate drugs.

Features of use:

Use at pregnancy and feeding by a breast. Special researches of safety of use of Kabiven central at pregnancy and in the period of a lactation were not conducted. Before Kabiven's appointment central at pregnancy and in the period of a lactation it is necessary to estimate carefully potential advantage of therapy for mother and possible risk for a fruit or the baby.

Use at abnormal liver functions. It is contraindicated at the expressed liver failure.

Use at renal failures. It is contraindicated at a renal failure of heavy degree in the absence of a hemodialysis or haemo filtering.

Special instructions. Kabiven central has osmolarity of 1060 ¼Äß¼/l and therefore are not suitable for in/in introductions to peripheral veins both at adults, and at children because of danger of development of thrombophlebitis.

At Kabiven's introduction central or sepsis careful control of concentration of TG in a blood plasma is surely necessary for patients with disturbance of metabolism of lipids owing to a renal failure, a diabetes mellitus, pancreatitis, disturbance of functions of a liver, a hypothyroidism (with a gipertriglitseridemiya).

At use of drug it is necessary to control ability to removal of lipids by measurement of concentration of TG in a blood plasma in 5-6 h after the last reception of fats.

The syndrome of a fatty overload can be observed at the recommended infusion speed if at the patient the clinical state sharply changes and the heavy renal or liver failure develops.

It is necessary to calculate carefully the volume of the administered drug and to adjust it according to a water balance and a condition of food of the patient. Each container is intended for disposable.

The expressed disturbances of an electrolytic and water balance need to be adjusted prior to infusion.

At the beginning of infusion observation of the patient is required. As any infusion in the central vein is followed by the increased risk of development of an infection, during introduction of a catheter or at manipulations with it it is necessary to follow strict rules of an asepsis in order to avoid infection.

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

At long introduction of lipids it is necessary to control cellular composition of blood and indicators of a blood coagulation.

In this drug there are no vitamins and microelements therefore for carrying out full parenteral food they should be entered in addition. For their completion Vitalipid is recommended to use N the adult or Vitalipid of N children's, Soluvit of N, Addamel N.

At emergence of any symptoms and signs of allergic reactions infusion should be stopped immediately.

Existence of lipids in Kabivena central can change results of some laboratory analyses (for example, concentration of bilirubin, activity of a lactate dehydrogenase, hemoglobin saturation by oxygen) if the sample of blood was received until sufficient removal of lipids from a blood-groove. At most of patients the entered lipids are removed in 5-6 h.

In/in administration of amino acids can be followed by strengthening of renal removal of microelements, especially zinc. Additional introduction of microelements can be required by the patients needing in long food.

The beginning of parenteral food can cause the shift of a water balance leading to a fluid lungs and congestive heart failure in strongly exhausted patients. Besides, during 24-48 h in a blood plasma decrease in potassium concentrations, phosphorus, magnesium and water-soluble vitamins can be observed. It is recommended to begin parenteral food slowly with careful control and the corresponding correction of amount of liquid, electrolytes, vitamins and microelements.

Kabiven central it is not necessary to enter through one catheter and along with blood or blood preparations because of risk of development of pseudo-agglutination.

Administration of insulin can be required by patients with a hyperglycemia.

The venous catheter through which full parenteral food is entered is not recommended to be used for in/in administrations of other solutions and drugs.

Any remains from an open container have to be destroyed

Use in pediatrics. Kabiven central is intended first of all for patients 2 years are more senior. At children under 2 years Kabiven central it is possible to apply only according to vital indications in the absence of the special adapted amino-acid solutions containing taurine (Aminoven infantas).

Premature children and children with a low weight at the birth can have the broken metabolism of fats. It is necessary to control concentration of TG carefully.

Side effects:

Allergic reactions: anaphylactic reaction, fever, fever, shiver, skin rash, small tortoiseshell.

From respiratory system: changes of breath (tachypnea).

From cardiovascular system: decrease or increase in the ABP.

From the alimentary system: increase in activity of enzymes of a liver, abdominal pains.

From system of a hemopoiesis: hemolysis, reticulocytosis.

Local reactions: thrombophlebitis at infusion in peripheral veins.

Others: headache, priapism.

At the correct introduction side effects develop extremely seldom.

Interaction with other medicines:

Heparin in therapeutic doses causes passing release in a lipoproteinlipase blood stream that can bring in the beginning to strengthening of a lipolysis in a blood plasma, and then to passing reduction of clearance of TG.

Insulin can influence activity of a lipase too, but data on adverse influence of this factor on the therapeutic value of drug are absent.

The K1 vitamin which is contained in soy oil is an antagonist of derivatives of coumarin therefore it is recommended to control carefully coagulability of blood at the patients receiving these drugs.

Kabiven central it is possible to mix only with those medicines and nutrient solutions for which compatibility with it is confirmed, for example: Vitalipid of N adult and Vitalipid of N children's; Soluvit N; Addamel of N; Dipeptiven. Mixing of solutions should be carried out in aseptic conditions.

Contraindications:

— the expressed lipidemia;

— the expressed liver failure;

— the expressed blood coagulation disturbances;

— inborn disturbances of metabolism of amino acids;

— a renal failure of heavy degree in the absence of a hemodialysis or haemo filtering;

— acute phase of shock;

— a hyperglycemia at which administration of insulin in a dose more than 6 PIECES/h is required;

— patholologically the increased concentration in a blood plasma of any of the electrolytes which are a part of drug;

— the general contraindications to infusional therapy: acute fluid lungs, overhydratation, dekompensirovanny heart failure and hypotonic dehydration;

— unstable states (including a posttraumatic state, a noncompensated diabetes mellitus, a myocardial infarction in an acute stage, a decompensated metabolic acidosis, heavy sepsis and a giperosmolyarny coma);

— hypersensitivity to egg or soy proteins or to any auxiliary component of drug.

With care it is necessary to use drug at disturbance of metabolism of lipids owing to a renal failure, a diabetes mellitus, pancreatitis, an abnormal liver function, a hypothyroidism (with a gipertriglitseridemiya) or sepsis. At Kabiven's introduction central careful control of concentration of TG in a blood plasma is surely necessary for patients with such disturbances.

Overdose:

Symptoms: owing to disturbance of ability of removal of fats development of a syndrome of a fatty overload - a lipidemia, fever, a gepatosplenomegaliya, anemia, a leukopenia, thrombocytopenia, a coagulopathy and a coma is possible.

Treatment: termination of infusion of lipids, symptomatic therapy.

Storage conditions:

Drug should be stored in the place, unavailable to children, at a temperature not above 25 °C; not to freeze. A drug period of validity in an outside bag - 2 years. After disclosure of fixers and mixing of three solutions it is possible to add compatible additives through inlet opening to mix. After disclosure of fixers chemical and physical stability of the mixed contents of three cameras remains during 24 h at 25 °C. For ensuring microbiological safety mix should be used right after administration of additives. If mix is not used at once, then on condition of observance of an asepsis at administration of additives emulsion mix can be stored up to 6 days at a temperature from 2 °C to 8 °C, after that mix should be used during 24 h.

Issue conditions:

According to the recipe

Packaging:

1540 ml - containers plastic three-chambered Biofin (1) with antioxidant - bags plastic (2) - boxes cardboard.
1540 ml - containers plastic three-chambered Biofin (1) with antioxidant - bags plastic (3) - boxes cardboard.
1540 ml - containers plastic three-chambered Biofin (1) with antioxidant - bags plastic (4) - boxes cardboard.
2053 ml - containers plastic three-chambered Biofin (1) with antioxidant - bags plastic (2) - boxes cardboard.
2053 ml - containers plastic three-chambered Biofin (1) with antioxidant - bags plastic (3) - boxes cardboard.
2053 ml - containers plastic three-chambered Biofin (1) with antioxidant - bags plastic (4) - boxes cardboard.
1026 ml - containers plastic three-chambered Biofin (1) with antioxidant - bags plastic (2) - boxes cardboard.
1026 ml - containers plastic three-chambered Biofin (1) with antioxidant - bags plastic (3) - boxes cardboard.
1026 ml - containers plastic three-chambered Biofin (1) with antioxidant - bags plastic (4) - boxes cardboard.
2053 ml - containers plastic three-chambered Biofin (1) with antioxidant - bags plastic (2) - boxes cardboard.
2053 ml - containers plastic three-chambered Biofin (1) with antioxidant - bags plastic (3) - boxes cardboard.
2053 ml - containers plastic three-chambered Biofin (1) with antioxidant - bags plastic (4) - boxes cardboard.