Kabiven central - instructions for use, doses, side effects, contraindications

Volume of bag	2566 ml		2053 ml		1540 ml		1026 ml
Glucose 19%	1316 ml		1053 ml		790 ml		526 ml
Vamin 18 Novum	750 ml		600 ml		450 ml		300 ml
Intralipid 20%	500 ml		400 ml		300 ml		200 ml
Energy value	2300 kcal 1900 kcal 1400 kcal						900 kcal
Composition:
after mixing 3 chambers:
Active components:	2566 ml		2053 ml		1540 ml		[1026 ml
soy bean oil	100 g		80g		60 grams		40 grams
glucose (dextrose)	275 g		220 g		165 grams		110 g
monohydrate that matches
dextrose anhydrous	250 grams		200 g		150g		. 100 g
L-alanine	12.0 g		9.6 g		7.2 g		4.8 g
L-arginine	8.5 g		6.8 g		5.1 g		3.4 g
L- aspartic acid	2.6 g		2.0 g		1.5 g		1.0 g
L-valine	5.5 g		4.4 g		3.3 g		2.2 g
L-histidine	5.1 g		4.1 g		3.1 g		2.0 g
Glycine
(aminoacetic acid)	5.9 g		4.7 g		3.6 g		2.4 g
L- glutamic acid	4.2 g		3.4 g		2.5 grams		1.7 g
L- isoleucine	4.2 g		3.4 g		2.5 grams		1.7 g
L- leucine	5.9 g		4.7 g		3.6 g		2.4 g
L- lysine hydrochloride	8.5 g		6.8 g		5.1 g		3.4 g
which corresponds to lysine	6.8 g		5.4 g		4.1 g		2.7 g
L- methionine	4.2 g		3.4 g		2.5 grams		1.7 g
L- proline	5.1 g		4.1 g		3.1 g		2.0 g
L-serine	3.4 g		2.7 g		2.0 g		1.4 g
L- tyrosine	0.17 g		0.14 g		0.10 g		0.07 g
L-threonine	4.2 g		3.4 g		.2.5 g		1.7 g
L- tryptophan	1.4 g		1.1 g		0.86 g		0.57 g
L- phenylalanine	5.9 g		4.7 g		3.6 g		2.4 g
calcium chloride dihydrate	0.74 g		0.59 g		0.44 g		0.29 g
which corresponds to calcium chloride 0.56 g				0.44 g		0.33 g		0.22 g
Sodium glycerophosphate (anhydrous) 3.8 g				3.0 g		2.3 g		1.5 g
magnesium sulfate heptahydrate		2.5 grams		2.0 g		1.5 g		0.99 g
which corresponds to magnesium sulfate 1.2 g				0.96 g		0.72 g		0.48 g
potassium chloride		4.5 g		3.6 g		2.7 g		1.8 g
sodium acetate trihydrate		6.1 g		4.9 g		3.7 g		2.5 grams
which corresponds to sodium acetate 3.7 g				2.9 g		2.2 g		1.5 g
auxiliary components: egg yolk phospholipids 6.0 g				4.8 g		3.6 g		2.4 g
glycerol (anhydrous)		11.0 g		8.8 g		6.6 g		4.4 g
Acetic acid glacial sodium hydroxide water for injection		q.s. for pH correction q.s. to adjust the pH to 2566 ml to 2053 ml to				1540 ml		up to 1026 ml
That corresponds to:
- Amino acids		85 grams		68 grams		51 grams		34 grams
- Nitrogen		13.5 g		10.8 g		8.1 g		5.4 g
- Fats		100 g		80g		60 grams		40 grams
- Carbohydrates - glucose (anhydrous)		250 grams		200 g		150g		100 g
- Energy
- Total		2300 kcal		1900 kcal		1400 kcal		900 kcal
- non-protein		2000 kcal		1600 kcal		1200 kcal		800 kcal
- Electrolytes
- sodium		80 mmol		64 mmol		48 mmol		32 mmol
- Potassium		60 mmol		48 mmol		36 mmol		24 mmol
- magnesium		10 mmol		8 mmol		6 mmol		4 mmol
- calcium		5 mmol		4 mmol		3 mmol		2 mmol
- phosphate		25 mmol		20 mmol		15 mmol		10 mmol
- sulfate		10 mmol		8 mmol		6 mmol		4 mmol
- chloride		116 mmol		93 mmol		70 mmol		46 mmol
- acetate		97 mmol		78 mmol		58 mmol		39 mmol

Osmolality about 1230 mosmole / kg of water

- Osmolarity about 1060 mosmol / l

Description:

Glucose 19% - a transparent, almost colorless solution that does not contain foreign particles.

Vamin 18 Novum is a clear, colorless or slightly yellowish solution that does not contain foreign particles.

Intralipid 20% - white or white with a cream shade of color, a homogeneous emulsion. When mixing the contents of three cameras - a white emulsion.

Pharmacotherapeutic group:nutrition parenteral remedy

ATX: & nbsp

B.05.B.A Solutions for parenteral nutrition

Pharmacodynamics:

Pharmacological properties of the drug are determined by its composition.

Vamin 18 Novum is intended for parenteral nutrition of patients with various pathologies with increased protein requirement, when enteral nutrition is ineffective or impossible.

Glucose is an indispensable source of rapidly released energy, which is necessary, including, for the metabolism of amino acids.

Intralipid It is used for parenteral nutrition of patients as a source of energy and irreplaceable fatty acids. Intralipid is indicated to patients with deficiency of essential fatty acids, unable to independently replenish the normal balance of essential fatty acids by oral intake.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. Unlike chylomicrons, Intralipid does not contain esters of cholesterol and apolipoprotein, and the content of phospholipids in it is higher.

Pharmacokinetics:

FATTY EMULSION

Intralipid is excreted from the bloodstream in the same way as chylomicra. Exogenous fat particles are mainly hydrolyzed in the blood and are captured by low-density lipoprotein receptors in the liver and peripheral tissues. The rate of excretion is determined by the composition of the fat particles, the clinical condition and nutritional status of the patient, and the speed of infusion. The maximum clearance of Intralipid on an empty stomach is equivalent to 3.8 + 1.5 gritiglycerides / kg / day.

AMINO ACIDS AND ELECTROLYTES

The pharmacokinetic characteristics of amino acids and electrolytes administered intravenously are the same as when administered with 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.

GLUCOSE

The pharmacokinetic characteristics of glucose administered by infusion are the same as when administered with normal food.

Indications:

Parenteral nutrition for adults and children from the age of 2, when oral or enteral nutrition is impossible, is insufficient or contraindicated.

Contraindications:

- Known hypersensitivity to egg or soy protein or to any auxiliary component of the drug

- Expressed hyperlipidemia

- Severe hepatic impairment

- Severe blood clotting disorders

- Congenital disorders of amino acid metabolism.

- Severe renal failure in the absence of hemodialysis or hemofiltration.

- Acute phase of shock.

- Hyperglycemia, requiring the introduction of insulin in an amount of more than 6 U / hour.

- Pathologically elevated plasma concentrations of any of the composition of the preparation of electrolytes.

- General contraindications to infusion therapy: acute edema of the lungs, hyperhydration, decompensated heart failure and hypotonic dehydration.

- Unstable conditions (eg, post-traumatic state, uncompensated diabetes mellitus, acute myocardial infarction, decompensated metabolic acidosis, severe sepsis and hyperosmolar coma).

Carefully:

when the metabolism of lipids due to renal insufficiency, diabetes, pancreatitis, impaired liver function, hypothyroidism (with hypertriglyceridemia), or sepsis. When Kabiven® is administered to the central patient with such disorders, careful monitoring of the concentration of triglycerides in blood plasma

Kabiven® Central is primarily designed for patients older than 2 years. In children under 2 years old Kabinen® central can be used only for vital signs in the absence of special adapted amino acid solutions containing taurine Aminoven Infant.

Premature babies and children with low birth weight may have an impaired metabolism of fats. The level of triglycerides should be carefully monitored.

Pregnancy and lactation:

Specialized safety studies of Kabinen® central during pregnancy and lactation were not conducted. Before the appointment of Kabiven® to the central pregnant and lactating women, the physician should assess the risk / benefit ratio.

Dosing and Administration:

Intravenously drip, only in 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.

Dosage and infusion rate are determined by the ability of the patient 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 1.0-2.0 g / kg / day, which equals the requirement for nitrogen of 0.15-0.30 g / kg / day. This corresponds to 27-40 ml of Kabini central ® per 1 kg of body weight per day.

In patients without severe catabolic stress, the need for amino acids is 0.7-1.3 g / kg / day, which equals the requirement for nitrogen 0.10-0.20 g / kg / day.This corresponds to 19-38 ml of Kabini Central ® per 1 kg of body weight per day.

The maximum daily dose

Adults

40 ml / kg / day. This is equal to one bag (the largest size is 2566 ml) for a patient weighing 64 kg and provides intake of 1.3 g of amino acids / kg / day (0.21 g nitrogen / kg / day), 31 kcal / kg / day of non-protein energy, 3 , 9 g 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.

Children

The dosage is determined by the patient's ability to metabolize individual nutrients.

Infusion for children (from 2 to 10 years) should start with low doses (14-28 ml / kg / day, the dose should be increased by 10-15 ml / kg / day, the maximum dose of 40 ml / kg / day).

In children older than 10 years, you can use the same doses as in adults.

Infusion rate:

The rate of infusion of Kabiven® Central should not exceed 2.6 ml / kg / h, which corresponds to a glucose infusion rate of 0.25 g / kg / h, amino acids 0.09 g / kg / h and 0.13 g / kg / h fat . The recommended duration of Kabivena® infusion is 12-24 hours.

Tool for using a three-chamber bag

- Remove the outer bag by tearing it at the notch and pulling it along the bag.

- With the thumb and forefinger of both hands, firmly grasp the side walls of the bag above 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 fully.

- Similarly, open the latch between chambers 2 and 3. Mix the contents by turning the pouch several times.

- If it is necessary to add (with known compatibility, for example, preparations of vitamins, trace elements), wipe the membrane of the inlet with an antiseptic.

- Place the bag on the table, holding the base of the inlet, completely insert the needle through the center of the membrane and enter the additive (with known compatibility). Before adding another additive, thoroughly mix the contents by turning the bag over and over again.

- Remove the cap from the needle of the infusion system by grasping the ring with your thumb and index finger and pulling the ring up. Use an infusion system without air access or shut off air access on a system that has air access.

- Place the bag on a flat surface. While holding the bag with the outlet hole up, completely insert the needle through the membrane, turning and pushing it if necessary.To secure the needle securely, it must be fully inserted.

- Hang the bag on the rack and follow the instructions for the infusion system and the infusion pump.

- Another way to open the latches: put the bag on a flat surface and fold it off the handle side until the latches open. Thoroughly mix the contents by turning the bag several times.

Note: Separate introduction of components from separate Kabinen® central chambers is technically impossible (with the exception of Intralipid), although each Kabinen® component of the central: Vamin, Intralipid and glucose solution can be used as separate preparations.

Side effects:

Side effects with proper administration are extremely rare:

allergic reactions (anaphylactic reaction, fever, chills, tremors, skin rash, urticaria)

changes in respiration (tachypnea) and hyper- or hypotension,

increased activity of liver enzymes,

hemolysis,

reticulocytosis.

abdominal pain,

headache,

priapism.

Overdose:

The syndrome of fat overload.

The impaired capacity to remove fats can lead to the development of fat overload syndrome.This may be the result of an overdose, but it can also occur at the recommended infusion rate if the patient has a dramatic change in clinical status and develops severe renal or hepatic insufficiency.

The syndrome of fat overload is characterized by hyperlipidemia, fever, hepatosplenomegaly, anemia, leukopenia, thrombocytopenia, coagulopathy and coma.

Treatment

Termination of lipid infusion, symptomatic therapy.

Interaction:

Heparin in clinically applied doses causes a transient release into the bloodstream of lipoprotein lipase, which can lead in the beginning to increased lipolysis in the blood plasma, and then to a transient weakening of the clearance of triglycerides.

Insulin, too, can affect lipase activity, but there is no evidence of an adverse effect of this factor on the therapeutic value of the drug.

Vitamin K1, contained in soybean oil, is an antagonist of coumarin derivatives, therefore it is recommended to carefully monitor blood coagulability in patients receiving these drugs.

Compatibility.

Kabiven® central can be mixed only with those medicines and nutrient solutions,for which it is confirmed compatibility with it, for example:

- Vitalipid N is an adult and Vitalipid N is a child;

- Soluwit H;

- Addamel N;

- Dyepteven.

Mixing solutions should be carried out under aseptic conditions.

Special instructions:

Solutions Kabivena central have an osmolality of 1060 mOsm / l and therefore are not suitable for intravenous injection into peripheral veins in both adults and children because of the risk of developing thrombophlebitis.

When Kabiven® is administered to a patient with a disorder of lipid metabolism due to renal failure, diabetes mellitus, pancreatitis, impaired liver function, hypothyroidism (with hypertriglyceridemia), or sepsis, careful monitoring of triglyceride concentration in blood plasma is absolutely essential;

When using the drug should monitor the ability to remove lipids by measuring the concentration of triglycerides in the blood plasma in 5. -6 hours after the last intake of fats.

Care should be taken to calculate the amount of the drug administered and adjust it in accordance with the water balance and nutritional status of the patient. Each container is designed for single use. Severe disturbances of the electrolyte and water balance must be corrected before the infusion begins.

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 check the concentrations of glucose and electrolytes in the blood plasma, as well as osmolarity, water balance, acid-base state and activity of liver enzymes.

With prolonged administration of lipids, it is necessary to control the cellular composition of blood and blood coagulation.

In this preparation, there are no vitamins and trace elements, therefore, to carry out complete parenteral nutrition, they should be administered additionally. For their replenishment, it is recommended to use Vitalipid N adult or Vitalipid N children, Soluwit N, Addamel N.

If any symptoms and signs of allergic reactions appear, the infusion should be stopped immediately.

The presence of lipids in the Kabinen® central may alter the results of some laboratory tests (eg, bilirubin concentration,activity of lactate dehydrogenase, saturation of hemoglobin with oxygen), if a blood sample was obtained before the sufficient removal of lipids from the bloodstream. In most patients, lipids are injected after 5-6 hours.

Intravenous introduction of amino acids can be accompanied by an increase in renal excretion of trace elements, especially zinc. Patients who require prolonged intravenous nutrition may require additional micronutrient administration. In severely depleted patients, the onset of parenteral nutrition can cause a shift in the water balance leading to pulmonary edema and congestive heart failure. In addition, within 24-48 hours in blood plasma can be observed a decrease in the concentrations of potassium, phosphorus, magnesium and water-soluble vitamins. It is recommended to begin parenteral nutrition slowly with careful monitoring and appropriate correction of the amount of fluid, electrolytes, vitamins and trace elements.

Kabiven® central should not be administered through a single catheter and simultaneously with blood or blood products because of the risk of developing pseudoagglutination.

Patients with hyperglycemia may require the administration of insulin.

A venous catheter through which complete parenteral nutrition is introduced is not recommended for intravenous administration of other solutions and preparations.

Any residues from the open container must be destroyed.

Form release / dosage:

Emulsion for infusion.

Packaging:1026 ml, 1540 ml, 2053 ml, 2566 ml of the mixture are placed in a three-chamber plastic container "Biophin", each chamber containing one of the solutions: a chamber containing a glucose solution of 19% (526 ml, 790 ml, 1053 ml and 1316 ml, respectively ), a chamber containing Vamin 18 Novum (300 ml, 450 ml, 600 ml and 750 ml, respectively), a chamber containing Intralipid 20% (200 ml, 300 ml, 400 ml and 500 ml respectively). Each container, together with the antioxidant, is placed in an outer plastic bag.

For 2, 3 or 4 bags together with the instructions for use are placed in a cardboard box (for hospitals).

Storage conditions:

At a temperature not exceeding 25 ⁰ C. Do not freeze.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiry date printed on the package.

Shelf life after mixing with additives.

After opening the latches and mixing the three solutions, compatible additives can be added to the mixture through the inlet.

After the latches are opened, the chemical and physical stability of the mixed contents of the three chambers is maintained for 24 hours at 25 ° C.

To ensure microbiological safety, the mixture should be used immediately after the addition of additives. If the mixture is not used immediately, then, under the condition of aseptic compliance with the administration of additives, the emulsion mixture can be stored for up to 6 days at 2 ° -8 ° C, after which the mixture should be used within 24 hours.

Terms of leave from pharmacies:For hospitals

Registration number:LS-000417

Date of registration:15.09.2009

The owner of the registration certificate:Fresenius Kabi Deutschland GmbHFresenius Kabi Deutschland GmbH Germany

Manufacturer: & nbsp

FRESENIUS KABI, AB Sweden

Representation: & nbspFRESENIUS KABI DEYCHLAND GmbH FRESENIUS KABI DEYCHLAND GmbH Germany

Information update date: & nbsp17.07.2014

Illustrated instructions

Instructions

Kabiven® central (Kabiven® central)