Kabiven peripheral - instructions for use, dose, side effects, contraindications

Volume of bag	2400 ml			1920 ml		1440 ml
Glucose 11%	1475 ml			1180 ml		885 ml
Vamin 18 Novum	500 ml			400 ml		300 ml
Intralipid 20%	425 ml			340 ml		255 ml
Energy Value	1700 kcal			1400 kcal		1000 kcal
Composition: after mixing 3 chambers: Active components:			2400 ml of 1920 ml			1440 ml
soy bean oil			85 grams	68 grams		51 grams
glucose (dextrose)			178 g	143 grams		107 grams
monohydrate that corresponds to anhydrous dextrose			162g	130 grams		97 g
L-alanine			8.0 g	6.4 g		4.8 g
L-arginine			5.6 g	4.5 g		3.4 g
L-aspargic acid			1.7 g	1.4 g		1.0 g
L-valin			3.6 g	2.9 g		2.2 g
L-cystidine			3.4 g	2.7 g		2.0 g
Glycine (aminoacetic acid)			4.0 g	3.2 g		2.4 g
L-glutamic acid			2.8 g	2.2 g		1.7 g
L-isoleucine			2.8 g	2.2 g		1.7 g
L-leucine			4.0 g	3.2 g		2.4 g
Llysine hydrochloride			5.6 g	4.5 g		3.4 g
which corresponds to lysine			4.5 g	3.6 g		2.7 g
L-methionine			2.8 g	2.2 g		1.7 g
L-proline			3.4 g	2.7 g		2.0 g
L-serine			2.2 g	1.8 g		1.4 g
L-tyrosine			0.12 g	0.092 g		0.069 g
L-treonine			2.8 g	2.2 g		1.7 g
L-tryptophan			0.95 g	0.76 g		0.57 g
L-phenylalanine			4.0 g	3.2 g		2.4 g
calcium chloride dihydrate		0.49 g			0.39 g		0.29 g
which corresponds to calcium chloride		0.37 g			0.30 g		0.22 g
sodium glycerophosphate (anhydrous)		2.5 grams			2.0 g		1.5 g
magnesium sulfate heptahydrate		1.6 g			1.3 g		0.99 g
which corresponds to magnesium sulfate		0.80 g			0.64 g		0.48 g
potassium chloride		3.0 g			2.4 g		1.8 g
sodium acetate trihydrate		4.1 g			3.3 g		2.5 grams
which corresponds to sodium acetate		2.4 g			2.0 g		1.5 g
auxiliary components:
egg yolk phospholipids		5.1 g			4.1 g		3.1 g
glycerol (anhydrous)		9.4 g			7.5 g		5.6 g
acetic acid glacial		q.s. for pH correction
sodium hydroxide		q.s. for pH correction
water for injections		up to 2400 ml			up to 1920 ml		up to 1440 ml
That corresponds to:
- Amino acids		57 grams			45 grams		34 grams
- Nitrogen		9.0 g			7.2 g		5.4 g
- Fats - Carbohydrates		85 grams			68 grams		51 grams
- glucose (anhydrous)		162g			130 grams		97 g
- Energy
- Total		1700 kcal			1400 kcal		1000 kcal
- non-protein		1500 kcal			1200 kcal		900 kcal
- Electrolytes
- sodium		53 mmol			43 mmol		32 mmol
- Potassium		40 mmol			32 mmol		24 mmol
- magnesium		6.7 mmol			5.3 mmol		4 mmol
- calcium		3.3 mmol			2.7 mmol		2 mmol
- phosphate		18 mmol			14 mmol		11 mmol
- sulfate		6.7 mmol			5.3 mmol		4 mmol
- chloride		78 mmol			62 mmol		47 mmol
- acetate		65 mmol			52 mmol		39 mmol

- Osmolality about 830 mosmole / kg of water

- Osmolarity about 750 mOsmol / l

Description:

Glucose 11% - 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:Parenteral nutrition.

ATX: & nbsp

B.05.B.A Solutions for parenteral nutrition

Pharmacodynamics:

Pharmacological properties of the drug are determined by its composition.

Vamin 18 H is intended for parenteral nutrition of patients with various pathologies with increased protein requirements: therapy and prevention of the state of protein deficiency before and after surgical interventions, trauma, burns, maxillofacial surgery, ENT-practice, when enteral nutrition is ineffective or impossible.

Glucose is an indispensable source of fast-releasing energy, necessary, including for the metabolism of amino acids.

Intralipid It is used for parenteral nutrition of patients as a source of energy and essential 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 cholesterol and apolipoprotein esters, and the content of phospholipids in it is higher. Rates of excretion and oxidation depend on the clinical condition of the patient; excretion and oxidation are accelerated during sepsis and after trauma, and, conversely, slow down in renal failure and hypertriglyceridemia.

With the simultaneous infusion of glucose solution and lipid emulsion, the risk of thrombophlebitis (due to decreased osmolarity of glucose during dilution) that always exists when hypertensive solutions are infused into peripheral veins is reduced.

Pharmacokinetics:

FATTY EMULSION

Intralipid is excreted from the bloodstream in the same way as chylomicra. Exogenous lipid particles are mainly hydrolyzed in the blood and captured by low-density lipoprotein 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.In healthy volunteers, the maximum clearance of Intralipida on an empty stomach is equivalent to 3.8 + 1.5 g 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.

AMINO ACIDS AND ELECTROLYTES

The pharmacokinetic characteristics of amino acids and electrolytes administered by intravenous infusion are basically the same as when they are fed 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.

GLUCOSE

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

Indications:

Parenteral nutrition of adults and children, 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 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.

- Hemophagocytic syndrome

- Unstable states (eg, post-traumatic state, uncompensated diabetes mellitus, myocardial infarction in the acute stage, 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 introduced Kabivena® peripheral patients with such disorders necessarily need careful monitoring of the concentration of triglycerides in the blood plasma; in patients with metabolic acidosis (eg,lactic acidosis); in patients with increased osmolarity of the blood and patients who need plasma-substituting therapy; in patients with a tendency to delay electrolytes.

Kabiven® peripheral is intended primarily for patients older than 2 years. Children under 2 years Kabiven® peripheral It can be used only for vital indications 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:

Special Security Studies Kabivena® peripheral during pregnancy and lactation was not carried out. Before appointment Kabivena® peripheral pregnant and lactating women, the physician should assess the risk / benefit ratio.

Dosing and Administration:

Intravenously, drip.

Solutions Kabivena® peripheral have osmolality of 830 mosm / kg H2O, and therefore can be introduced into peripheral or central veins. This applies to both adults and children.

Infusion can be continued for as long as the clinical state of the patient requires, based on the daily requirement for dextrose, lipids and amino acids. Dosage and speed of infusion are determined by the patient's ability to excrete lipids and metabolize dextrose.

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 size of the bag should take into account the patient's condition, body weight and the need for nutrients.

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 is approximately equal to the requirement for nitrogen of 0.15-0.30 g / kg / day. The energy requirement is 30-50 kcal / kg / day.

In patients without catabolic stress, the requirement for amino acids is 0.7-1.0 g / kg / day, which is approximately equal to the requirement for nitrogen 0.10-0.15 g / kg / day. The energy requirement is 20-30 kcal / kg / day.This corresponds to 27-40 ml of Kabivena peripheral® per 1 kg of body weight per day.

The maximum daily dose

Adults

40 ml / kg / day. This equals one bag (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 non-protein energy, 2.7 g dextrose / kg / day and 1.4 g lipids / kg / day.

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, 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, 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 maximum rate of infusion of dextrose is 0.25 g / kg / h.

The dose of amino acids should not exceed 0.1 g / kg / h.

The intake of lipids should not be more than 0.15 g / kg / h.

The infusion rate should not exceed 3.7 ml / kg / hour, which corresponds to a dose of dextrose, amino acids and lipids, respectively 0.25 g / kg, 0.09 g / kg and 0.13 g / kg. The recommended duration of infusion of a single bag of the drug for peripheral use is 12-24 hours.

Instuukiya on the use of 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, 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.

- 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.

- Put the bag on the table; While 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.

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

- 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 chambers Kabivena® peripheral it is technically impossible (with the exception of Intralipid), although each component Kabivena® peripheral: Vamin, Intralipid and glucose solution can be used as separate preparations.

Side effects:

Data on side effects, when administered correctly, 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,

- thrombophlebitis with infusion into peripheral veins, 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.

Interaction with other drugs.

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 can also affect the activity of lipase, 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.

Interaction:

Kabiven® peripheral can be mixed only with those medicines and nutritional Solutions for which compatibility with it has been confirmed:

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

- Solovit N.

- Addamel N.

- Dipeptivny.

Mixing solutions should be carried out under aseptic conditions.

Special instructions:

When using the drug should monitor the ability to remove lipids. It is recommended to perform this by measuring the level of triglycerides in the blood plasma 5-6 hours after the last intake of fats.

The concentration of triglycerides in blood plasma during infusion should not exceed 3 mmol / l.

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. Each container is designed for single use.

Violations of electrolyte and water balance (eg, abnormally high or low levels of electrolytes in blood plasma) should be corrected up tothe beginning of infusion.

At the beginning of any intravenous infusion, careful monitoring 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, the cellular composition blood and blood coagulation.

In patients with renal failure, the balance of phosphates and potassium should be carefully monitored 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.

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

The presence of lipids in Kabivene® peripheral may alter the results of some laboratory tests (eg., the concentration of bilirubin, lactate dehydrogenase, hemoglobin oxygen saturation) if the blood sample was obtained prior to sufficient removal of lipids from the blood stream. 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® peripheral Do not enter through a single catheter at the same time as blood or blood products.

Patients with hyperglycemia may require insulin administration. A venous catheter through which complete parenteral nutrition is administered is not recommended for intravenous administration other solutions and preparations.

Gathering the leftovers from the open container must be destroyed.

To carry out full parenteral nutrition, you must additionally enter microelements and vitamins.

Form release / dosage:

Emulsion for infusion.

Packaging:1440 ml, 1920 ml, 2400 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 11% (885 ml, 1180 ml and 1475 ml, respectively), a chamber containing Wamin 18 Novum (300 mL, 400 mL and 500 mL respectively), a chamber containing Intralipid 20% (255 mL, 340 mL and 425 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 of no higher than 25 ° C. Do not freeze.

Keep out of the reach of children.

Shelf life:

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 introduction of additives, the emulsion mixture can be stored for up to 6 days at a temperature of 2 ° -8 ° C, after which the mixture should be used within 24 hours.

Terms of leave from pharmacies:For hospitals

Registration number:LS-000418

Date of registration:18.09.2009

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: & nbsp22.07.2014

Illustrated instructions

Instructions

Kabiven® peripheral (Kabiven® peripheral)