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

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Dosage form: & nbspEmulsion for infusion.

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

Volume of bag	1206 ml	1448 ml	1904 ml
Amino acid solution	380 ml	456 ml	600 ml
Dextrose 13%	656 ml	788 ml	1036 ml
Fat emulsion	170 ml	204 ml	268 ml
Energy value	800 kcal	1000 kcal	1300 kcal
Composition: after mixing 3 chambers:	1206 ml	1448 ml	1904 ml	1000 ml
Active components
L-alanine	5.3 g	6.4 g	8.4 g	4,4
L-arginine	4.6 g	5.5 g	7.2 g	3.8 g
Glycine	4.2 g	5.1 g	6,6 g	3.5 grams
L-histidine	1.1 g	1.3 g	1.8 g	0.93 g
L-isoleucine	1.9 g	2.3 g	3.0 g	1.6 g
L-leucine	2.8 g	3.3 g	4.4 g	2.3 g
L-lysine (in the form of lysine acetate)	2.5 grams	3.0 g	4.0 g	2.1 g
L-methionine	1.6 g	1.9 g	2.6 g	1.3 g
L-phenylalanine	1.9 g	2.3 g	3.1 g	1.6 g
L-proline	4.2 g	5.1 g	6.7 g	3.5 grams
L-serine	2.5 grams	3.0 g	3.9 g	2.1 g
Taurine	0.38 g	0.46 g	0.60 g	0.32 g
L-treonine	1.7 g	2.0 g	2.6 g	1.4 g
L-tryptophan	0.76 g	0.91 g	1.2 g	0.63 g
L-tyrosine	0.15 g	0.17 g	0.24 g	0.12 g
L-valin	2.4 g	2.9 g	3.7 g	2.0 g
Calcium chloride (in the form of calcium, chloride dihydrate)	0.21 g	0.26 g	0.34 g	0.18 g
Sodium glycerophosphate (in the form of sodium glycerophosphate hydrate)	1.6 g	1.9 g	2.5 grams	1.3 g
Magnesium sulfate (in the form of magnesium sulfate heptahydrate)	0.46 g	0.55 g	0.72 g	0.38 g
Potassium chloride	1.7 g	2.0 g	2.7 g	1.4 g
Sodium acetate (as sodium acetate trihydrate)	1.3 g	1.6 g	2.0 g	1.1 g
Zinc sulfate (in the form of zinc heptahydrate sulfate)	0.005 g	0.006 g	0.008 g	0.004 g
Glucose (dextrose) (in the form of dextrose monohydrate)	85 grams	103 grams	135 grams	71 grams
Soybean oil refined oil	10.2 g	12.3 g	16.1 g	8.5 g
Medium chain triglycerides	10.2 g	12.3 g	16.1 g	8.5 g
Olive oil (refined)	8.5 g	10.1 g	13.4 g	7.0 g
Fish oil (enriched with omega-3 fatty acids)	5.1 g	6.1 g	8.0 g	4.2 g
Auxiliary components
Glycerol	4.3 g	5.1 g	6.7 g
egg yolk phospholipids	2.0 g	2.4 g	3.2 g
Sodium oleate	0.051 g	0.061 grams	0.080 g
Racemic mixture of α-Tocopherols	27.7-38.3 mg	33.3-45.9 mg	43.7-60.3 mg
Sodium hydroxide (pH regulator)	q.s.	q.s.	q.s.
Acetic Acidic Acid	q.s.	q.s.	q.s.
Water for injections	1206 ml	1448 ml	1904 ml	1000 ml
That corresponds to:
Carbohydrates
- Dextrose (anhydrous)	85 grams	103 grams	135 grams	71 grams
amino acids	38 grams	46 grams	60 grams	32 grams
nitrogen	6.2 g	7.4 g	9.8 g	5.1 g
fats	34 grams	41 grams	54 grams	28 grams
Energy value	800 kcal	1000 kcal	1300 kcal	700 kcal
Non-protein energetic value	700 kcal	800 kcal	1100 kcal	600 kcal
Electrolytes
- sodium	30 mmol	36 mmol	48 mmol	25 mmol
- Potassium	23 mmol	28 mmol	36 mmol	19 mmol
- magnesium	3.8 mmol	4.6 mmol	6.0 mmol	3.2 mmol
- calcium	1.9 mmol	2.3 mmol	3.0 mmol	1.6 mmol
- phosphate	9.9 mmol	11.9 mmol	15.6 mmol	8.2 mmol
- zinc	0.03 mmol	0.03 mmol	0.05 mmol	0.02 mmol
- sulfate	3.8 mmol	4.6 mmol	6.1 mmol	3.2 mmol
- chloride	27 mmol	32 mmol	42 mmol	22 mmol
- acetate	79 mmol	96 mmol	125 mmol	66 mmol

Osmolality is about 950 mOsmol / kg of water
Theoretical osmolarity of about 850 mOsmol / l
The pH after mixing is about 5.6.

Description:Dextrose 13% - clear, colorless or with a yellowish hue solution.
A solution of amino acids is a clear, colorless or yellowish shade 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
Fat emulsion SMOFKabiven® peripheral includes SMOFLipid (SMOF - SMOF - an abbreviation that includes the first letters of the sources of the oils included in the preparation: Soya oil - Soybean oil, Medium chain triglycerides MST - medium chain triglycerides, Olive oil - Olive oil, Fish oil - fish oil ), which by particle size and biological properties is identical to endogenous chylomicrons. Components of fat emulsion SMOFKabiven® peripheral - 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 rich in linoleic acid (approximately 55-60%), which is an ω-6 fatty acid. 8% of the soybean oil composition is represented by α-linolenic acid, which is ω -3 fatty acid. Fat emulsion, part of the preparation SMOFKabiven® peripheral, 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 / a 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 values, 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 that of LCT), and the highest clearance for 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 insufficiency.
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 the drug - SMOKKabiven® peripheral during pregnancy and lactation were not performed. Before prescribing SMOKKabiven® peripheral to pregnant and lactating women, the doctor should evaluate the risk / benefit ratio.

Dosing and Administration:Intravenously drip.
SMOKKabiven® 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 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 r / kg / day of amino acids). Patients with moderate and severe catabolic stress with or without nutritive status require 0.15-0.25 g / kg of nitrogen per day (0.9-1.6 g / kg / day of 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 20 - 40 ml / kg * day of the preparation SMOFKabiven® peripheral corresponds to 0.10-0.20 g / kg of nitrogen (0.6-1.3 g / kg / day of amino acids) and 14-28 kcal / kg day of energy (11 - 22 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 injection rate of SMOKKabiven® peripheral drug should not exceed 3.0 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 40 ml / kg / day and provides the patient with nitrogen in the amount of 0.20 g / kg / day (corresponding to 1.3 g / kg / day of amino acids), dextrose in the amount of 2.8 g / kg / fat in the amount of 1.1 g / kg / day and energy of 28 kcal / kg / day (corresponding to 22 kcal / kg / day of non-protein energy).
Pediatric Patients
SMOKKabiven® peripheral can be used in children from 2 years of age.
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, moleno apply the same dose as in adults.
The duration of application of SMOKKabiven® peripheral drug is usually from 5 to 7 days, however, depending on the patient's condition, it can be extended to 3-4 weeks.
Precautions for use
SMOKKabiven® peripheral should be used with caution in patients with impaired fat metabolism, which can be observed in patients with renal insufficiency, diabetes mellitus, pancreatitis, impaired liver function, hypothyroidism and sepsis. With the introduction of SMOFKabiven® peripheral to patients with such disorders, careful monitoring of triglyceride concentration in plasma and glucose concentration in the blood is essential.
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. The oxygen scavenger (in an 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 add additives (with known compatibility, for example, special preparations of vitamins, microelements, dipeptivene), remove (break off) the cap with the arrow from the port of white 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 stoic
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;
- disorders 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 the SMOKKabiven® peripheral 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). The syndrome of overload with fat is characterized by hyperlipidemia, fever, fatty liver,hepatomegaly with or without jaundice, splenomegaly, anemia, leukopenia, thrombocytopenia, coagulation disorders, hemolysis and reticulocytosis, disturbance of liver function laboratory parameters 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 infusion rate of SMOFKabiven® is peripheral, the amino acids contained in it may lead to undesirable phenomena. Possible development of nausea, vomiting, chills and 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, infusion of the SMOFKabiven® peripheral 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.
When hyperglycaemia occurs, therapy should be performed in accordance with the clinical situation by prescribing short-acting insulin and / or correcting the infusion speed of SMOFKabiven® peripheral drug.
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 K₁. However, its content in the preparation SMOFKabiven® peripheral is so small that the effect on the clotting process in patients receiving indirect anticoagulants is negligible.
Compatibility
SMOKKabiven® peripheral can be mixed only with those medicines and nutrient solutions for which it has 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 SMOFKabiven® peripheral have osmolarity of 850 mOsm / l and are therefore suitable for intravenous administration in both peripheral and central veins.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 SMOKKabiven® peripheral.
SMOKKabiven® peripheral 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 insufficiency, the administration of potassium and phosphate should be conducted with caution to prevent the development of hyperkalemia and hyperphosphatemia.
Additional amounts of electrolytes and should be added to the preparation SMOFKabiven® peripheral taking into account the clinical situation, and their plasma concentrations must 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 SMOKKabiven® peripheral solution may lead to incorrect results of some laboratory tests (such as bilirubin, lactate dehydrogenase, oxygen saturation of hemoglobin, hemoglobin) if blood samples were obtained before removing fat from the bloodstream. 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 SMOKKabiven® peripheral.
In patients with impaired nutritional status, the onset of parenteral nutrition may lead to some fluid retention, which in turn may contribute to the development of pulmonary edema and chronic heart failure,as well as a decrease in the concentration of potassium, phosphorus, magnesium and water-soluble vitamins in plasma. These phenomena can occur within 24 to 48 hours after the onset of parenteral nutrition. They can be avoided by starting parenteral nutrition gradually, as well as carefully monitored. and in time to make corrections to the amounts of electrolytes, minerals, vitamins and liquids being introduced.
SMOKKabiven® peripheral 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 1206 ml, 1448 ml or 1904 ml of the mixture in a three-chamber plastic container "Biophin", each chamber containing one of the solutions: a chamber containing a solution of glucose 13% (656 ml, 788 ml or 1,036 ml, respectively), a chamber containing an amino acid solution (380 ml, 456 or 600 ml, respectively), a chamber containing a fat emulsion (170 ml, 204 ml or 268 ml, respectively).Each container (made of polypropylene) together with an antioxidant is placed in an outer plastic bag (made of polyethylene).
4 bags together with 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. 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 impossible to use SMOKKabiven® peripheral 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 not possible to use SMOKKabiven® peripheral immediately after mixing with supplements,the shelf life of the drug 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-000627

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: & nbsp2016-12-22