SMOKKabiven central - instructions for use, dose, side effects, contraindications

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Dosage form: & nbspEmulsion for infusion.

Composition:SMOKKabiven® central is produced in a three-chamber bag and is presented in four volumes.
Each bag contains the following volumes of solutions, depending on the size of the bag:

Volume of bag	986 ml	1477 ml	1970 ml	2463 ml
Amino acid solution	500 ml	750 ml	1000 ml	1250 ml
Dextrose 42%	298 ml	446 ml	595 ml	744 ml
Fat emulsion	188 ml	281 ml	375 ml	469 ml
Energy value	1100 kcal	1600 kcal	2200 kcal	2700 kcal
Composition:
after mixing 3 chambers:	986 ml	1477 ml	1970 ml	2463 ml	1000 ml
Active components
L-alanine	7.0 g	10.5 g	14.0 grams	17.5 g	7.1 g
L-arginine	6.0 g	9.0 g	12.0 g	15.0 grams	6.1 g
Glycine	5.5 g	8.2 g	11,0 g	13.8 g	5.6 g
L-histidine	1.5 g	2.2 g	3.0 g	3.7 g	1.5 g
L-isoleucine	2.5 grams	3.8 g	5.0 grams	6.2 g	2.5 grams
L-leucine	3.7 g	5.6 g	7.4 g	9.4 g	3.8 g
L-lysine (in the form of lysine acetate)	3.3 g	5.0 grams	6.6 g	8.4 g	3.4 g
L-methionine	2.2 g	3.2 g	4.3 g	5.4 g	2.2 g
L-phenylalanine	2.6 g	3.8 g	5.1 g	6.4 g	2.6 g
L-proline	5.6 g	8.4 g	11.2 g	14.0 grams	5.7 g
L-serine	3.2 g	4.9 g	6.5 g	8.1 g	3.3 g
Taurine	0.50 g	0.75 g	1.0 g	1.2 g	0.5 g
L-treonine	2.2 g	3.3 g	4.4 g	5.4 g	2.2 g
L-tryptophan	1.0 g	1.5 g	2.0 g	2.5 grams	1.0 g
L-tyrosine	0.20 g	0.30 g	0.40 g	0.49 g	0.20 g
L-valin	3.1 g	4.6 g	6.2 g	7.6 g	3.1 g
Calcium chloride (in the form of calcium, chloride dihydrate)	0.28 g	0.42 g	0.56 g	0.69 g	0.28 g
Sodium glycerophosphate (in the form of sodium glycerophosphate hydrate)	2.1 g	3.1 g	4.2 g	5.2 g	2.1 g
Magnesium sulfate (in the form of magnesium sulfate heptahydrate)	0.60 g	0.90 g	1.2 g	1.5 g	0.61 g
Potassium chloride	2.2 g	3.4 g	4.5 g	5.7 g	2.3 g
Sodium acetate (as sodium acetate trihydrate)	1.7 g	2.6 g	3.4 g	4.2 g	1.7 g
Zinc sulfate (in the form of zinc heptahydrate sulfate)	0.0065 grams	0.0097 g	0.013 g	0.016 g	0.0066 grams
Glucose (dextrose) (in the form of dextrose monohydrate)	125 grams	187 grams	250 grams	313 grams	127 grams
Soybean oil refined oil	11.3 g	16.9 g	22.5 g	28.1 g	11.4 g
Medium chain triglycerides	11.3 g	16.9 g	22.5 g	28.1 g	11.4 g
Olive oil (refined)	9.4 g	14.1 g	18.8 g	23.4 g	9.5 g
Fish oil (enriched with omega-3 fatty acids)	5.6 g	8.4 g	11.3 g	14.0 grams	5.7 g
Auxiliary components
Glycerol	4.7 g	7.0 g	9.4 g	11.7 g
egg yolk phospholipids	2.3 g	3.4 g	4.5 g	5.6 g
Sodium oleate	0.06 g	0.08 g	0.11 g	0.14 g
Racemic mixture of α-Tocopherols	30.6-42.3 mg	45.8-63.2 mg	61.1-84.4mg	76.4-105.5mg
Sodium hydroxide (pH regulator)	q.s.	q.s.	q.s.	q.s.
Hydrochloric acid	q.s.	q.s.	q.s.	q.s.
Acetic Acidic Acid	q.s.	q.s.	q.s.	q.s.
Water for injections	986 ml	1477 ml	1970 ml	2463 ml	1000 ml
That corresponds to:
Carbohydrates
- Dextrose (anhydrous)	125 grams	187 grams	250 grams	313 grams	127 grams
amino acids	50 grams	75 grams	100 g	125 grams	51 grams
nitrogen	8 grams	12 grams	16 grams	20 grams	8 grams
fats	38 grams	56 grams	75 grams	94 grams	38 grams
Energy value	1100 kcal	1600 kcal	2200 kcal	2700 kcal
Non-protein energetic value	900 kcal	1300 kcal	1800 kcal	2200 kcal
Electrolytes
- sodium	40 mmol	60 mmol	80 mmol	100 mmol	41 mmol
- Potassium	30 mmol	45 mmol	60 mmol	74 mmol	30 mmol
- magnesium	5.0 mmol	7.5 mmol	10 mmol	12 mmol	5.1 mmol
- calcium	2.5 mmol	3.8 mmol	5.0 mmol	6.2 mmol	2.5 mmol
- phosphate	12 mmol	19 mmol	25 mmol	31 mmol	13 mmol
- zinc	0.04 mmol	0.06 mmol	0.08 mmol	0.1 mmol	0.04 mmol
- sulfate	5.0 mmol	7.5 mmol	10 mmol	13 mmol	5.1 mmol
- chloride	35 mmol	52 mmol	70 mmol	89 mmol	36 mmol
- acetate	104 mmol	157 mmol	209 mmol	261 mmol	106 mmol

Osmolality is about 1800 mOsmol / kg water
Theoretical osmolarity of about 1500 mOsmol / l
pH after mixing is about 5.6

Description:Dextrose 42% - clear, colorless or with a yellowish hue solution.
amino acid solution - Transparent, colorless or yellowish white solution. Fat emulsion is a white homogeneous emulsion.
When mixing the contents of the three chambers - a white homogeneous emulsion.

Pharmacotherapeutic group:Parenteral nutrition.

Pharmacodynamics:Pharmacological properties of the drug are determined by its composition.
Fat emulsion
A fat emulsion comprises a central SMOFKabiven® SMOFlipid (SMOF - SMOF - abbreviation comprising first letters oils sources included in the preparation: Soya oil - Soy oil, Medium chain triglycerides MCT - medium chain triglycerides, Olive oil - Olive oil, Fish oil - fish oil ), which is a particle size and biological properties identical to endogenous chylomicrons.Components of fat emulsion SMOFKabiven® central - soybean oil, medium chain triglycerides, olive oil and fish oil - except for differences in composition and energy density, have their own pharmacodynamic properties.
In soybean oil contains a large number of essential fatty acids. It is most abundantly rich in linoleic acid (approximately 55-60%), which is an ω-6 fatty acid. 8% of the composition of soybean oil is represented by a-linolenic acid, which is an ω-3 fatty acid. The fat emulsion, which is part of the SMOKKabiven® central preparation, provides the necessary amount of essential fatty acids.
By means of medium chain fatty acids, the body is provided with readily available energy, due to its ability to rapidly oxidize.
Olive oil supplies energy in the form of monounsaturated fatty acids, which are much less prone to oxidation compared to the corresponding amount of polyunsaturated fatty acids.
Fish oil is characterized by a high content of eicosapentaenoic (EPA) and docosahexaenoic (DHA) acids.DHA is an important structural component of cell membranes, and EPA is a precursor of eicosanoids, such as prostaglandins, thromboxanes and leukotrienes.
Amino acids and electrolytes
Amino acids are part of the proteins of ordinary food and are used by the body to synthesize proteins in tissues / and their excess is metabolized along a number of biochemical pathways. Studies indicate a thermogenic effect of intravenous amino acids.
Dextrose
Glucose (dextrose) is an indispensable source of fast-releasing energy, necessary, including, for the metabolism of amino acids.

Pharmacokinetics:Fat emulsion
Various triglycerides in the composition of SMOFLipid have different clearance rates, but SMOFLipid on average (as a mixture) is eliminated faster than long-chain triglycerides (LCT). The lowest clearance from all components of SMOFLipid in olive oil (slightly lower than LCT), and the highest clearance in medium chain triglycerides (MCT). Fish oil in LCT mixture has the same clearance as pure LCT.
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.
Dextrose
Pharmacokinetic characteristics of glucose (dextrose), 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, fish oil 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 access to hemodialysis or hemofiltration.
- Acute phase of shock.
- Uncontrolled hyperglycemia.
- 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.
- Hemafagocyte syndrome / macrophage activation syndrome
- Unstable conditions (eg, post-traumatic state, uncompensated diabetes mellitus, acute myocardial infarction, decompensated metabolic acidosis, septic shock and hyperosmolar coma).

Pregnancy and lactation:Special safety studies of SMOFKabiven® central preparation during pregnancy and lactation were not performed. Before prescribing SMOFKabiven®, the doctor should assess the risk / benefit ratio for pregnant and lactating women.

Dosing and Administration:Intravenously drip, only in neutral veins.
SMOKKabiven® 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.
The dose and rate of infusion of the drug should be determined by the patient's ability to metabolize fat, nitrogen and glucose, as well as his nutrient and energy needs.
The need for nitrogen to maintain the protein composition of the body depends on the patient's condition (i.e., its nutritional status and the degree of catabolic stress).
Dosing regimen in adults
For patients with normal nutritional status or in a state of mild catabolic stress, the requirement for nitrogen is 0.10 to 0.15 g / kg-day (0.6 to 0.9
g / kg-day amino acids). Patients with moderate and severe catabolic stress, with or without nutritional status, need 0.15-0.25 g / kg-day nitrogen (0.9-1.6 g / kg-day amino acids). In some situations (such as in patients with burns or in severe catabolism), the need for nitrogen may be even higher.
The dose of 13-31 ml / kg-day of the preparation SMOFKabiven® central corresponds to 0.10-0.25 g / kg-day nitrogen (0.6-1.6 g / kg-day amino acids) and 14-35 kcal / kg- day of energy (12 - 27 kcal / kg-day of non-protein energy). This dose range covers the needs of most patients.
Infusion rate:
The maximum infusion rate for dextrose is 0.25 g / kg-h, for amino acids 0.1 g / kg-h, and for lipids 0.15 g / kg-h.
The maximum rate of SMOKKabiven® central injection should not exceed 2.0 ml / kg-h (this corresponds to the maximum infusion rate of dextrose, amino acids and lipids). The recommended duration of the infusion is 12-24 hours.
The maximum daily dose
The maximum daily dose varies depending on the clinical state of the patient and can change over time. The recommended maximum daily dose is 35 ml / kg-day and provides the patient with nitrogen in the amount of 0.28 g / kg-day (corresponding to 1.8 g / kg / day of amino acids), dextrose in the amount of 4.5 g / kg / fat in the amount of 1.33 g / kg / day and energy of 39 kcal / kg / day (corresponding to 31 kcal / kg / day of non-protein energy).
Pediatric Patients
SMOKKabiven® central can be used in children from 2 years old.
The dose 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). The upper limit of the protein load in children is 4 g / kg.
In children older than 10 years, you can use the same doses as in adults. The duration of use of the SMOKKabiven® central preparation is usually 5 to 7 days, however, depending on the patient's condition, it can be extended to 3-4 weeks.
Precautions for use
SMOKKabiven® central should be used with caution in patients with impaired fat metabolism, which can be observed in patients with renal insufficiency, diabetes, pancreatitis, impaired liver function, hypothyroidism and sepsis.
When the preparation is administered, SMOKKabiven® central to patients with such disorders, a careful control of the concentration of triglycerides in plasma and the concentration of glucose in the blood is necessary.
The use of the drug for newborns and children under 2 years is not recommended because of the lack of clinical experience.
Recommendations for the preparation of the Biophin container for use
1. Notch on outer bag
2. Holder
3. Hole for hanging the package
4. Segregated partition
5. Blind port (not used)
6. Input port (for additives)
7. Output port (for the infusion system)
8.Oxygen Absorber (in external package)

1. Removing an external package-
Place the container on a horizontal surface. Tear the outer bag in place of the notch, pulling along the edge.
Remove the outer package, discard with oxygen scavenger.

2. Mixing
Place the three-chamber bag on a horizontal surface (see picture).
Fold the package from the corner on the side of the holder diagonally in the direction of the "blind" port.

Then, while holding the folded part with one hand and keeping a constant pressure inside the bag, apply pressure (press) the other hand onto the "bag" until the vertical partitions open.

Vertical partitions are opened due to the created pressure of the contents of the package!
A horizontal partition is not necessary to open - the contents of the chambers are easily mixed after opening only the vertical partitions.

Mix the contents of the chambers; turning the package 2-3 times. (Note: the partitions can be opened in an external package, after which you can remove the external package).

3. Connection of the infusion system
If it is necessary to introduce additives (with known compatibility, for example special preparations of vitamins,microelements, dipeptivene), remove (break off) the cap with the arrow from the white port just before adding additives.
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.

Connecting the infusion system: Remove the cap from the blue port just before inserting the needle.
While holding the bag with the outlet hole up, insert the needle through the membrane, turning and pushing it if necessary. Use an infusion system without air access or shut off air access on a system that has air access.
(Note - the inside of the ports is sterile)

4. Suspension on the infusion rack
Hang the bag on the stand (using the hole on the holder)

Side effects:Side effects with proper administration are extremely rare.
Unwanted reactions are possible:
- From the side of the cardiovascular system: tachycardia, increase or decrease in blood pressure;
- On the part of the respiratory system: dyspnea.
- on the part of the digestive tract: a violation of appetite, nausea, vomiting;
- metabolic disorders: increased activity of "liver" enzymes in plasma;
- violations associated with the site of administration of the drug: local fever, hyperemia.
- hypersensitivity reactions: anaphylactic and anaphylactoid reactions, skin rash, hives, fever, chills.
- from the side of the central nervous system: headache, dizziness.
If these side effects occur, the infusion of SMOFKabiven® central drug should be discontinued, and then, if necessary, continued at a lower rate.
To prevent the risk associated with too high a speed of infusion, it is recommended to use a volumetric infusion pump.

Overdose:Overload syndrome fat
The impaired ability to metabolize triglycerides can lead to the development of "Fat-Overload Syndrome", which can be caused by an overdose of lipids. It is necessary to pay attention to possible signs of metabolic overload.
The causes of impaired lipid metabolism can be genetic (individual changes in metabolism), in addition to fat metabolism may affect the present or previous diseases.High hypertriglyceridemia and fat overload syndrome can develop even at the recommended rate of drug administration if the patient's clinical condition suddenly changes (for example, kidney function or infectious complications develop). fat overload syndrome is characterized by hyperlipidaemia, fever, liver fatty infiltration, hepatomegaly with or without icterus, splenomegaly, anemia, leucopenia, thrombocytopenia, blood coagulation disorders, hemolysis and reticulocytosis, violation of laboratory liver function tests and coma. Symptoms, as a rule, are reversible and stop when the infusion of fat emulsion ceases.
Introduction of large amounts of amino acids
As with other amino acid solutions, if the recommended speed of infusion with SMOFKabiven® is central, the amino acids contained in it can lead to undesirable phenomena. Perhaps the development of nausea, vomiting, chills and increased sweating. Infusion of amino acids can also cause a rise in body temperature. If renal function is impaired, concentrations of nitrogen-containing metabolites such as creatinine and urea.
Excessive administration of dextrose
If the rate of infusion of dextrose will exceed the threshold of its clearance, the patient will develop hyperglycemia.
With the development of symptoms of overload with fat or amino acids, the infusion of SMOFKabiven® central drug should be stopped or its speed should be reduced. When there is an overdose of these drugs, there is no specific antidote. Immediate measures for lipid and amino acid overdose are reduced to life support measures with special attention to the respiratory and cardiovascular systems. In addition, it is necessary to carry out thorough biochemical monitoring and to conduct therapy for specific metabolic disorders.
If hyperglycaemia occurs, therapy should be performed in accordance with the clinical situation by prescribing short-acting insulin and / or correcting the infusion rate of SMOFKabiven® central.
In addition, overdose can lead to fluid overload, electrolyte imbalance and hyperosmolar condition. In rare cases, if these symptoms become difficult, the possibility of hemodialysis, haemofiltration or hemodiafiltration should be considered.

Interaction:Some medications, such as insulin, can interact with the body's lipase system. However, this type of interaction is of limited clinical importance.
Heparin in therapeutic doses causes a temporary release of lipoprotein lipase into the bloodstream. This can lead to increased lipolysis in the plasma, followed by a decrease in the clearance of triglycerides.
Soybean oil contains vitamin K_1. However, its content in the preparation SMOFKabiven® central is so small that its effect on the process of blood coagulation in patients receiving indirect anticoagulants is negligible.
Compatibility.
SMOKKabiven® central can only be mixed with those medicines and nutrient solutions that have been confirmed to be compatible with it (vitamins, trace elements, glutamine preparations for parenteral administration, electrolyte solutions), for example:
1. Vitalipid H is an adult and Vitalipid N is a child; .
2. Solovit H;
3. Addamel H;
4. Dipeptivny.
Any addition to the drug should be carried out under aseptic conditions. The solution is intended for single use only.Remains of the solution after the infusion is complete must be destroyed.

Special instructions:Solutions of SMOKKabiven® central preparation have an osmolality of 1500 mOsm / l and are therefore not suitable for intravenous administration to peripheral veins, both in adults and children due to the risk of developing thrombophlebitis.
The ability to metabolize fat is individual for each patient, so the lipid profile of patients should be routinely monitored. Usually, monitoring is reduced to a daily determination of the triglyceride content. The concentration of triglycerides in the plasma during infusion should not exceed 4 mmol / l. Overdose of lipids can lead to a syndrome of overload with fat.
This medication contains soybean oil, fish oil and egg phospholipids, which in rare cases can cause allergic reactions. Allergy to soy and peanuts can be cross-linked. If any signs of an anaphylactic reaction (such as fever, chills, rash or dyspnea) occur, the drug infusion should be discontinued.
To prevent the risk associated with too high a speed of infusion, it is recommended to use a volumetric infusion pump.
Violations of the water-electrolyte balance (for example, pathologically high or low concentrations of electrolytes in the plasma) should be corrected before the infusion of SMOFKabiven® central preparation.
SMOKKabiven® central should be used with caution in patients with a tendency to delay electrolytes. In such patients, during any intravenous infusion, additional control of plasma electrolytes is required. At occurrence of any pathological attribute infusion should be stopped.
Considering the fact that with the use of central venous access the risk of infection is increased, it is necessary to strictly adhere to asepsis during catheterization of the central vein and manipulations with the catheter.
It is necessary to monitor the concentrations of glucose, electrolytes, plasma osmolarity, water balance, acid-base state and activity of liver enzymes at least once every three days.
When applying fat emulsions for a long time, it is recommended to periodically perform a general blood test and a coagulogram.
In patients with renal failure, the administration of potassium and phosphate should be conducted with caution to prevent the development of hyperkalemia and hyperphosphataemia.
Additional amounts of electrolytes should be added to SMOKKabiven® central in the clinical situation, and their plasma concentrations should be determined daily.
If the patient has lactate acidosis, insufficient oxygen delivery and increased osmolarity of the plasma, parenteral nutrition should be conducted with caution.
The fat content of the SMOFKabiven® central solution may lead to incorrect results from some laboratory tests (such as bilirubin, lactate dehydrogenase, hemoglobin oxygen saturation, hemoglobin) if blood samples were obtained before removing fat from the blood stream. In most patients, blood in the vascular bed is released from the fat content within 5-6 hours after cessation of its management.
Intravenous introduction of amino acids is accompanied by increased excretion of trace elements, in particular zinc and copper, with urine. This should be taken into account when adding micronutrients to the parenteral nutrition, especially if it will be carried out for a long time. In this case, it is necessary to take into account the amount of zinc, which is part of the preparation SMOFKabiven® central.
In patients with impaired, nutritional status, the onset of parenteral nutrition can lead to some fluid retention, which in turn can contribute to the development of pulmonary edema and chronic heart failure, as well as a decrease in potassium, phosphorus, magnesium and water-soluble vitamins in plasma.
These phenomena can occur, within 24 - 48 hours after the onset of parenteral nutrition. They can be avoided by starting parenteral nutrition gradually, as well as carefully monitor and timely correct for the amounts of electrolytes, minerals, vitamins and fluids to be administered.
SMOKKabiven® central should not be administered simultaneously with blood in one system because of the risk of developing pseudoagglutination.
Patients with hyperglycemia may require the appointment of insulin.

Effect on the ability to drive transp. cf. and fur:The drug is used to treat patients residing in intensive care units.

Form release / dosage:Emulsion for infusion.

Packaging:For 986 ml, 1477 ml, 1970 ml, 2463 ml of the mixture in a three-chamber plastic container "Biophin", each chamber of which contains one of the solutions: a chamber,containing a solution of dextrose 42% (298 ml, 446 ml, 595 ml or 744 ml respectively), a chamber containing an amino acid solution (500 ml, 750 ml, 1000 ml or 1250 ml, respectively), a chamber containing a fat emulsion (188 ml, 281 ml, 375 ml or 469 ml, respectively). Each container (made of polypropylene) together with an antioxidant is placed in an outer plastic bag (made of polyethylene).
By 3 (container 2463 ml) or 4 bags (containers of 986 ml, 1477 ml or 1970 ml) together with the instruction for use are placed in a cardboard box (for hospitals).

Storage conditions:At a temperature not exceeding 25 FROM. Do not freeze. Store in an outer bag.
Shelf life after mixing.
After the detents are opened, the chemical and physical stability of the mixed contents of the three chambers is maintained for 36 hours at 25 ° C.
To ensure microbiological safety, the mixture should be used immediately after mixing the contents of the chambers.
If it is not possible to use SMOKKabiven® Central immediately after mixing the chambers, the shelf life of the preparation should not exceed 24 hours at a temperature of 2-8 ° C.
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.
To ensure microbiological safety, the mixture should be used immediately after the addition of additives.
If it is impossible to use SMOKKabiven® Central immediately after mixing with additives, the shelf life of the preparation should not exceed 24 hours at a temperature of 2-8 ° C.
Keep out of the reach of children.

Shelf life:2 years.
Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:For hospitals

Registration number:LP-000628

Date of registration:23.09.2011 / 26.09.2016

Expiration Date:Unlimited

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: & nbsp2016-12-21