Description
Release form
SMOFKabiven ® central is available in a three-chamber bag and is presented in a volume of 986 ml.
986 ml bag contains: amino acid solution – 500 ml,
dextrose 42% – 298 ml,
fat emulsion – 188 ml.
Energy value of 1100 kcal.
Amino acid solution is clear, colorless or yellowish.
Dextrose 42% – a clear solution, colorless or with a yellowish tinge.
Fat emulsion – white, homogeneous.
When mixing the contents of the three chambers, a homogeneous white emulsion is formed.
Pharmacological action
SMOF central fat emulsion includes SMOFlipid (SMOF – SMOF is an abbreviation that includes the first letters of the oil sources that make up the preparation: Soya oil – Soybean oil, Medium chain triglycerides MCT – medium chain triglycerides, Olive oil – Olive oil, Fish oil – fish oil), which is identical in particle size and biological properties to endogenous chylomicrons. The components of the SMOF fat emulsion are central, soybean oil, medium chain triglycerides, olive oil and fish oil, in addition to differences in composition and energy density, have their own pharmacodynamic properties.
Soybean oil contains a large amount of essential fatty acids. It is most rich in linoleic acid (approximately 55-60%), which is a -6 fatty acid. 8% of the composition of soybean oil is represented by -Linolenic acid, which is -3 fatty acid. Fat emulsion, which is part of the drug, SMOFKabiven central, provides the necessary amount of essential, fatty acids.
Medium chain fatty acids provide the body with rapidly available energy due to their ability to oxidize quickly.
Olive oil supplies energy in the form of monounsaturated fatty acids, which are much less susceptible to oxidation than the corresponding amount of polyunsaturated fatty acids.
Fish oil is high in eicosapentaenoic (EPA) and docosahexaenoic (DHA) acids. DHA is an important structural component of cell membranes, and EPA is a precursor to eicosanoids such as prostaglandins, thromboxanes and leukotrienes.
Indications
Preparation for complete parenteral nutrition – solution of amino acids, fats, carbohydrates, electrolytes
– parenteral nutrition for adults and children from 2 years of age, when oral or enteral nutrition is impossible, insufficient or contraindicated.
Contraindications
severe hyperlipidemia
– severe hepatic insufficiency
– severe coagulation disorders
– congenital disorders of amino acid metabolism
– severe renal failure with no access to hemodialysis or acute hypertension 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
– hemaphagocytic syndrome / macrophage activation syndrome
– unstable conditions (for example, post-traumatic condition, uncompensated diabetes mellitus, acute myocardial infarction, decompensated metabolic acidosis, septic shock and hyperosmolar sensitivity) or soy proteins, fish oil, or any auxiliary component of the drug.
Use during pregnancy and lactation
Special safety studies of the drug SMOFKabiven ® central during pregnancy and lactation have not been conducted. Before the appointment of SMOFKabiven ®, the central pregnant and lactating women doctor must evaluate the expected benefits of therapy for the mother and the potential risk to the fetus or infant.
Special instructions
Recommendations for preparing the Biofin container for use with
1. Removing the external
package Place the container on a horizontal surface. Tear the outer bag at the notch by pulling along the edge.
Remove the outer bag, discard with the oxygen scavenger.
2. Mixing
Place the three-chamber bag on a horizontal surface. Roll the bag diagonally from the side of the holder in the direction of the blind port.
Then, holding the rolled part with one hand and maintaining a constant pressure inside the bag, apply force (press) with the other hand to the bag until the vertical partitions open.
Vertical partitions open due to the generated pressure of the package contents. You do not need to open the horizontal partition – the contents of the cameras mix easily after opening only the vertical partitions.
Mix the contents of the cameras by turning the bag 2-3 times. (Note: partitions can be opened in an external package, after which you can remove the external package).
3. Connection of the
infusion system. If necessary, supplementation (with known compatibility, for example, special preparations of vitamins, microelements, Diseptic), remove (break off) the cap with the arrow from the white port immediately before the introduction of additives.
While holding the base of the inlet, completely insert the needle through the center of the membrane and inject the additive (with known compatibility). Stir the contents thoroughly by turning the bag several times before introducing another supplement.
Connecting the infusion system: immediately before inserting the needle, remove the cap from the blue port.
Holding the bag with the outlet facing 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 with air access.
(Note: the inside of the ports is sterile).
4. Suspension on an infusion rack
Hang the bag on the rack (using the hole on the holder).
Composition
Infusion emulsion 986 ml
L-alanine 7 g
L-arginine 6 g
glycine 5. 5 g
L-histidine 1.5 g
L-isoleucine 2.5 g
L-leucine 3.7 g
L-lysine (in the form of acetate) 3.3 g
L-methionine 2.2 g
L-phenylalanine 2.6 g
L Proline 5.6 g
L-serine 3.2 g
taurine 500 mg
L-threonine 2.2 g
L-tryptophan 1 g
L-tyrosine 200 mg
L-valine 3.1 g
calcium chloride (in the form of dihydrate 280 mg) sodium glycerophosphate (hydrate) 2.1 g
magnesium sulfate (heptahydrate) 600 mg
potassium chloride 2.2 g
sodium acetate (trihydrate) 1.7 g
zinc sulfate (heptahydrate) 6.5 mg
dextrose (as monohydrate) 125 g
refined soybean oil 11.3 g
medium chain triglycerides 11.3 g
olive oil (refined) 9.4 g
fish oil (enriched with omega-3 fatty acids) 5.6 g
Inc: carbohydrates (dextrose) 125 g
amino acids 50 g
nitrogen 8 g
fats 38 g
energy value 1100 kcal
energy value non-protein 900 kcal
electrolytes: sodium 40 mmol
potassium 30 mmol 5 mmol srdlk
calcium 2.5 mmol
phosphate 12 mmol
zinc 0.04 mmol
sulfate 5 mmol
chloride 35 mmol
acetate 104 mmol
osmolality of about 1800 mOsmol / kg of water
theoretical osmol about 5.6
Excipients: glycerol – 4.7 g, egg yolk phospholipids – 2.3 g, n Tria oleate – 60 mg, a racemic mixture of tocopherol – 30.6-42.3 mg Sodium hydroxide – qs for correcting the pH, hydrochloric acid – qs for correcting the pH, acetic acid glacial – qs for correcting the pH, water d / i – up to 986 ml.
986 ml – three-chamber plastic containers Biofin (1) with antioxidant – plastic bags (4) – cardboard boxes.
Dosage and administration
The drug is administered intravenously, only in the central veins.
SMOFKabiven® Central is available in four sizes of bags designed for patients with normal, moderately increased or reduced nutrient requirements. 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 should take into account the patient’s condition, body weight and need for nutrients. In obese patients, the dose should be set based on ideal body weight. The dose and rate of infusion of the drug should be determined depending on the patient s ability to metabolize fat, nitrogen and glucose, as well as the need for nutrients and energy.
The need for nitrogen to maintain the protein composition of the body depends on the patient’s condition (i.e., his nutritional status and degree of catabolic stress).
Adults
For patients with normal nutritional status or in a state of mild catabolic stress, the need for nitrogen is 0.10-0.15 g / kg / day (0.6-0.9 g / kg / day of amino acids). Patients with moderate to severe catabolic stress with or without nutritional status impairment require 0.15-0.25 g / kg / day of nitrogen (0.9-1.6 g / kg / day of amino acids). In some situations (for example, in patients with burns or in a state of severe catabolism), the need for nitrogen may be even higher.
Dose 13-31 ml / kg / day of the drug SMOFKabiven® central corresponds to 0.10-0.25 g / kg / day of nitrogen (0.6-1.6 g / kg / day of amino acids) and 14-35 kcal / k / 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 administration of SMOFKabiven® central should not exceed 2.0 ml / kg / h (this corresponds to the maximum rate of infusion of dextrose, amino acids and lipids). The recommended duration of infusion is 12-24 hours.
Maximum daily dose
The maximum daily dose varies depending on the clinical condition of the patient and may change over time. The recommended maximum daily dose is 35 ml / kg / day and provides the patient with nitrogen in an amount of 0.28 g / kg / day (corresponding to 1.8 g / kg / day of amino acids), dextrose in an amount of 4.5 g / kg / day, fat in an amount of 1. 33 g / kg / day and an energy of 39 kcal / kg / day (which corresponds to 31 kcal / kg / day of non-protein energy).
Children
SMOFKabiven® central can be used in children 2 years of age and older. The dose is determined by the nature of the metabolism of individual nutrients in the patient’s body.
In children aged 2 to 10 years, infusion should be started with low doses (14-28 ml / kg / day, the dose should be increased by 10-15 ml / kg / day, the maximum dose is 40 ml / kg / day). The upper limit of protein load in children is 4 g / kg.
In children over 10 years of age, the drug can be used in the same doses as in adults. The duration of use of the drug SMOFKabiven® central is usually from 5 to 7 days, however, depending on the condition of the patient, it can be extended to 3-4 weeks.
Side effects
Side effects
Side effects when administered correctly are extremely rare.
From the cardiovascular system: tachycardia, increase or decrease in blood pressure.
From the respiratory system: shortness of breath.
From the digestive system: impaired appetite, nausea, vomiting, increased activity of liver enzymes in plasma.
From the nervous system: headache, dizziness.
Allergic reactions: anaphylactic and anaphylactoid reactions, skin rash, urticaria, fever, chills.
Local reactions: local temperature increase, hyperemia.
If the listed side effects appear, the infusion of SMOFKabiven ® Central should be stopped, then, if necessary, the infusion can be continued at a lower rate.
To prevent the risk of an infusion rate that is too high, a volumetric infusion pump is recommended.
Drug Interactions
Some drugs, such as insulin, may interact with the body s lipase system. However, this type of interaction has limited clinical value.
Heparin at therapeutic doses causes a temporary release of lipoprotein lipase into the bloodstream. This can lead to increased plasma lipolysis, followed by a decrease in triglyceride clearance.
Soybean oil contains vitamin K1. However, its content in the SMOFKabiven central preparation is so small that its effect on the blood coagulation process in patients receiving indirect anticoagulants is negligible.
Compatibility
SMOFKabiven ® central can be mixed only with those medicines and nutrient solutions for which it has been confirmed to be compatible (vitamins, trace elements, parenteral glutamine preparations, electrolyte solutions), for example:
1. Vitalipid H adult and Vitalipid N for children
2. Soluvit H
3. Addamel H
4. Dipeptive.
Any addition to the drug should be made under aseptic conditions. The solution is intended for single use only. Residual solution after completion of the infusion should be destroyed.
Overdose of
Fat overload syndrome
Impaired ability to metabolize triglycerides can lead to the development of fat overload syndrome, which can be caused by an overdose of lipids. You should pay attention to possible signs of metabolic overload. The causes of impaired lipid metabolism can be genetic (individual metabolic changes), in addition, present or previous diseases can affect fat metabolism. High hypertriglyceridemia and fat overload syndrome can develop even at the recommended rate of administration of the drug if the patient s clinical condition suddenly changes (for example, renal function is impaired or infectious complications develop
). Fat overload syndrome is characterized by hyperlipidemia, fever, fatty liver infiltration, hepatomegaly with or without jaundice, splenomegaly, anemia, leukopenia, thrombocytopenia, blood clotting disorders, hemolysis and reticulocytosis, impaired laboratory parameters of liver function and coma. Symptoms are usually reversible and stop when the infusion of the fat emulsion is stopped.
Introduction of large quantities of amino acids
As with other amino acid solutions, when the recommended infusion rate is exceeded by the drug SMOFKabiven ® central, the amino acids contained in it can lead to undesirable effects. Perhaps the development of nausea, vomiting, chills, and increased sweating. Amino acid infusion can also cause fever. In case of impaired renal function, concentrations of nitrogen-containing metabolites such as creatinine and urea may increase.
Excessive administration of dextrose
If the dextrose infusion rate exceeds its clearance threshold, the patient will develop hyperglycemia.
If symptoms of an overload of fat or amino acids develop, the infusion of SMOFKabiven ® Central should be stopped or its speed reduced. With an overdose of these drugs, there is no specific antidote. Urgent measures for an overdose of lipids and amino acids come down to life support measures with special attention to the respiratory and cardiovascular systems. In addition, careful biochemical monitoring and the treatment of specific metabolic disorders are necessary.
If hyperglycemia occurs, it is necessary to conduct therapy in accordance with the clinical situation by administering short-acting insulin and / or adjusting the rate of infusion of the drug SMOFKabiven ® central.
An overdose can also lead to fluid overload, an electrolyte imbalance, and a hyperosmolar state. In rare cases, if these symptoms become severe, hemodialysis, hemofiltration, or hemodiafiltration should be considered.
Storage conditions
The product should be stored out of the reach of children at a temperature not exceeding 25 ° C. Do not freeze. Store in an outer bag. Expiration – 2 years.
Expiration after mixing
After opening the latch, the chemical and physical stability of the mixed contents of the three chambers is maintained for 36 hours at 25 ° C. For microbiological safety, the mixture should be used immediately after mixing the contents of the chambers.
If it is impossible to use SMOFKabiven ® Central immediately after mixing the chambers, the Expiration of the preparation should not exceed 24 h at 2 ° to 8 ° C.
Expiration after mixing with additives
After opening the retainers and mixing the three solutions, it is possible to add compatible additives through the inlet. To ensure microbiological safety, the mixture should be used immediately after the administration of the additives.
If it is impossible to use SMOFKabiven ® Central immediately after mixing with additives, the Expiration of the drug should not exceed 24 hours at a temperature of 2 ° to 8 ° C.
terms of sale from
pharmacies Prescription
stvennaya form
simply entails infusing dlya
Fresenius Kabi, Germany
