Кабивен® peripheral

General characteristics. Structure:

Active ingredients: 51 g of oil of soybeans, 107 g of a dextrose (glucose) monohydrate that corresponds to 97 g of a dextrose of anhydrous, 4,8 g of L-alanine, 3,4 g of L-arginine, 1 g of L-aspartic acid, 2,2 g of L-valine, 2 g of a L-histidine, 2,4 g of glycine (aminoacetic acid), 1,7 g of L-glutaminic acid, 1.7 g of L-izoleytsina, 2,4 g of a L-leucine, 3,4 g of a L-lysine a hydrochloride that corresponds 2,7 g of a lysine, 1,7 g of L-methionine, 2 g of L-proline, 1,4 g of L-serine, 69 mg of L-tyrosine, 1,7 g of L-threonine, 570 mg of L-tryptophane, 2,4 g of L-phenylalanine, 290 mg of Calcii chloridum of a dihydrate that corresponds 220 mg of Calcii chloridum, 1,5 g of sodium of glycerophosphate (anhydrous), 990 mg of magnesium of sulfate of heptahydrate that corresponds 480 mg of magnesium of sulfate, 1,8 g of potassium of chloride, 2,5 g of sodium of acetate of trihydrate that corresponds to 1,5 g of sodium of acetate.

Including: 34 g of amino acids, 5,4 g of nitrogen, 51 g of fats, 97 g of carbohydrates - a dextrose (anhydrous); energy: only 1000 kcal, nonprotein 900 kcal; electrolytes: sodium of 32 mmol, potassium of 24 mmol, magnesium of 4 mmol, calcium of 2 mmol, phosphate of 11 mmol, sulfate of 4 mmol, chloride of 47 mmol, acetate of 39 mmol; osmolality of about 830 ¼Äß¼«½ý/kg waters, osmolarity about 750 ¼Äß¼«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. Means 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.

At simultaneous infusion of solution of a dextrose and lipidic emulsion the risk of development of thrombophlebitis (owing to decrease in osmolarity of a dextrose at cultivation) which always exists at injection of hypertonic salt solutions in peripheral veins decreases.

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. Kabiven peripheral has osmolarity 750 ¼Äß¼/l and therefore can administer the drug adults and children in peripheral or 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 peripheral is issued in bags of three 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. The need for energy makes 30-50 kcal/kg/days. It corresponds to 40 ml/kg/days.

At patients without catabolic stress the need for amino acids makes 0.7-1 g/kg/days that is approximately equal to the need for nitrogen of 0.1-0.15 g/kg/days. The need for energy makes 20-30 kcal/kg/days. It corresponds to 27-40 ml of Kabiven peripheral 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) for the patient with the body weight of 64 kg and provides receipt of 0.96 g of amino acids/kg/days (0.16 g of nitrogen/kg/days), 25 kcal/kg/days of nonprotein energy, 2.7 g of Dextrosums/kg/days and 1.4 g of lipids/kg/days.

At children at the age of 2-10 years infusion of drug should be begun with a low dose (14-28 ml/kg that corresponds to 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 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 3.7 ml/kg/h that corresponds to a dose of a dextrose, amino acids and lipids, according to 0:25 g/kg/h, 0.09 g/kg/h and 0.13 g/kg/h.

The recommended duration of infusion of Kabiven peripheral 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) to wipe 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.

Features of use:

Use at pregnancy and feeding by a breast. Special researches of safety of use of Kabiven peripheral at pregnancy and in the period of a lactation were not conducted. Before Kabiven's appointment peripheral 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. Contraindications: the expressed liver failure.

Use at renal failures. Contraindications: a renal failure of heavy degree in the absence of a hemodialysis or haemo filtering.

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

Concentration of TG in a blood plasma during infusion should not exceed 3 mmol/l.

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 which should be adjusted 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 should 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 control concentration of glucose and electrolytes in a blood plasma, and also osmolarity of plasma, a water balance, KShchR 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.

At patients with a renal failure it is necessary to control carefully balance of phosphates and potassium in order to avoid development of a hyperphosphatemia and a hyperpotassemia.

The amount of additional electrolytes should be defined by regular control of their concentration taking into account a clinical condition of the patient.

In this drug there are no vitamins and microelements. 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 peripheral can change results of some laboratory analyses (for example, concentration of bilirubin, activity of LDG, 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 peripheral it is not necessary to enter through one catheter along with blood or blood preparations.

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 peripheral is intended first of all for patients 2 years are more senior. At children under 2 years Kabiven peripheral 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:

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

Insulin can influence activity of a lipase too, but data on its adverse influence on a therapeutic effectiveness 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 peripheral 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 peripheral 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:

1440 ml - containers plastic three-chambered Biofin (1) with antioxidant - bags plastic (2) - boxes cardboard.
1440 ml - containers plastic three-chambered Biofin (1) with antioxidant - bags plastic (3) - boxes cardboard.
1440 ml - containers plastic three-chambered Biofin (1) with antioxidant - bags plastic (4) - boxes cardboard.