SMOF peripheral containers 1904 ml, 4 pcs. (amino acids for parenteral POWER)

Latin name

SMOFKabiven peripheral

Release form

SMOF is a peripheral amino acid solution.

Packaging

1904 ml - three-chamber plastic containers Biofin (1) with antioxidant - plastic bags (4) - cardboard boxes.

ФармакологичРскоРдРйствимbr>
Комбинированн й прРпарат для парРнтРрального питания. ФармакологичРскиРсвойства прРпарата опрРдРляются Рго составом.

Жировая эмульсия

Жировая эмульсия СМОФКабивРн® пРрифРричРский включаРт СМОФлипид (СМОФ - SMOF - аббрРвиатура, включающая пРрв Рбукв источников масРл, входящих в состав прРпарата: Soya oil - соРвоРмасло, Medium chain triglycerides MCT - срРднРцРпочРчн РтриглицРрид , Olive oil - оливковоРмасло, Fish oil - р бий жир), котор й по размРрам частиц и биологичРским свойствам идРнтичРн эндогРнн м хиломикронам. КомпонРнт жировой эмульсии СМОФКабивРн® пРрифРричРский - соРвоРмасло, срРднРцРпочн РтриглицРрид , оливковоРмасло и р бий жир - кромРразличий в составРи энРргРтичРской плотности, обладают своими собствРнн ми фармакодинамичРскими свойствами.

соРвом маслРсодРржится большоРколичРство нРзамРним х жирн х кислот. Оно болРРвсРго богато линолРвой кислотой (приблизитРльно 55-60%), которая являРтся -6 жирной кислотой. 8% состава соРвого масла прРдставлРно -линолРновой кислотой, являющРйся -3 жирной кислотой. Жировая эмульсия, входящая в состав прРпарата СМОФКабивРн® пРрифРричРский, обРспРчиваРт нРобходимоРколичРство нРзамРним х жирн х кислот.

ПосрРдством срРднРцРпочРчн х жирн х кислот организм обРспРчиваРтся б стродоступной энРргиРй, благодаря их способности б стро окисляться. ОливковоРмасло поставляРт энРргию в формРмононРнас щРнн х жирн х кислот, котор Рнамного мРньшРподвРржРн окислРнию по сравнРнию с соотвРтствующим количРством полинРнас щРнн х жирн х кислот.

Р бий жир характРризуРтся в соким содРржаниРм эйкозапРнтаРновой (ЕРА) и докозагРксаРновой (DНA) кислот. DHA являРтся важн м структурн м компонРнтом клРточн х мРмбран, а ЕРА являРтся прРдшРствРнником эйкозаноидов, таких как простагландин , тромбоксан и лРйкотриРн .

Аминокислот и элРктролит

Аминокислот входят в состав бРлков об чной пищи и используются организмом длясинтРза бРлков в тканях, а их излишРк подвРргаРтся мРтаболизму по ряду биохимичРских путРй. ИсслРдования свидРтРльствуют о тРрмогРнном эффРктРв/в ввРдРния аминокислот.

ДРкстроза

Глюкоза (дРкстроза) являРтся нРзамРним м источником б стро в свобождающРйся энРргии, нРобходимой, в т.ч., и для мРтаболизма аминокислот.

ФармакокинРтика

Жировая эмульсия

Различн РтриглицРрид в составРСМОФлипида имРют разн РпоказатРли клирРнса,но СМОФлипид в срРднРм (как смРсь) элиминируРтся б стрРР, чРм длинноцРпочн РтриглицРрид (LCT). Сам й низкий показатРль клирРнса из всРх компонРнтов СМОФлипида у оливкового масла (нРсколько нижР, чРм у LCT), а наиболРРв сокий клирРнс - у срРднРцРпочн х триглицРридов (МСТ). Р бий жир в смРси LCT обладаРт таким жРклирРнсом, как чист РLCT.

Аминокислот и элРктролит

ФармакокинРтичРскиРхарактРристики аминокислот и элРктролитов, вводим х внутривРнно, такиРжР, как при их поступлРнии с пищРй. Однако аминокислот бРлков пищи сначала попадают в портальную вРну пРчРни, и лишь затРм в систРмн й кровоток, в то врРмя как аминокислот , вводим Рв вРну, попадают нРпосрРдствРнно в систРмн й кровоток.

ДРкстроза

ФармакокинРтичРскиРхарактРристики глюкоз (дРкстроз ), вводимой путРм инфузии, такиРжР,как при РРпоступлРнии с об чной пищРй.

Indications

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 without access to hemodialysis or hemofiltration srdlkrp sharp blood pressure composition of the

electrolyte preparation general contraindications to infusion therapy: acute pulmonary edema, hyp rgidratatsiya, decompensated cardiac insufficiency and hypotonic dehydration

gemafagotsitarny syndrome / macrophage activation syndrome

unstable state (e.g., post-traumatic condition, uncompensated diabetes, acute myocardial infarction, decompensated metabolic acidosis, septic shock and hyperosmolar coma)

hypersensitivity to egg or soy proteins, fish oil or to any auxiliary component of the drug.

Use in cases of impaired liver function

Contraindicated in severe liver failure.

Caution is advised to use the drug in patients with impaired fat metabolism, which may be observed in patients with impaired liver function. With the introduction of the drug SMOFKabiven peripheral, such patients need to carefully monitor the concentration of triglycerides in plasma and the concentration of glucose in the blood.

Use for impaired renal function

Contraindicated in severe renal failure in the absence of access to hemodialysis or hemofiltration.

With caution, the drug should be used in patients with impaired fat metabolism, which can be observed in patients with renal failure. With the introduction of the drug SMOFKabiven peripheral, such patients need to carefully monitor the concentration of triglycerides in plasma and the concentration of glucose in the blood.

Use in children

The use of the drug in newborns and children under 2 years of age is not recommended due to insufficient clinical experience.

Use during pregnancy and lactation

Special safety studies of the drug SMOFKabivenВ® peripheral during pregnancy and lactation have not been conducted. Before prescribing the drug SMOFKabivenВ® peripheral to pregnant and lactating women, the expected benefit of therapy for the mother and the potential risk to the fetus or infant should be evaluated.

Composition of

1904 ml sack contains: amino acid solution - 1036 ml,

dextrose 13% - 600 ml,

fat emulsion - 268 ml.

Energy value of 1300 kcal.

Amino acid solution is clear, colorless or yellowish.

Dextrose 13% - 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.

Infusion emulsion 1904 ml

L-alanine 8.4 g

L-arginine 7.2 g

glycine 6.5 g

L-histidine1. 8 g

L-isoleucine 3 g

L-leucine 4.4 g

L-lysine (acetate) 4 g

L-methionine 2.6 g

L-phenylalanine 3.1 g

L-proline 6.7 g

L-serine3 .9 g

taurine 600 mg

L-threonine 2.6 g

L-tryptophan 1.2 g

L-tyrosine 240 mg

L-valine 3.7 g

calcium chloride (in the form of dihydrate) 340 mg

sodium glycerophosphate 2.5 g

magnesium sulfate (in the form of heptahydrate) 720 mg

potassium chloride 2.7 g

sodium acetate (in the form of trihydrate) 2 g

zinc sulfate (in the form of heptahydrate) 8 mg

dextrose (in the form of monohydrate) 135 g

oil peeled beans 16.1 g

triglyceride srednetsepochechnye16.1

g olive oil (refined) 13.4 g

fish oil (rich in omega 3 fatty acids) in 8 g

including .: ? carbohydrates (dextrose) 135 g

? amino acids 60 g

? nitrogen 9.8 g

? fats 54 g

energy value 1300 kcal

energy value non-protein 1000 kcal

electrolytes:? sodium 48 mmol

? potassium 36 mmol 6 mmol

? calcium 3 mmol

? phosphate 15.6 mmol

? zinc 0.05 mmol

? sulfate 6.1 mmol

? chloride 42 mmol

? acetate 125 mmol

osmolality about 950 mOsmol / kg of water

theoretical lm about 5.6

Excipients: glycerol - 6.7 g, egg yolk phospholipids - 3.2 g, sodium oleate - 80 mg, a racemic mixture of β-tocopherols - 43.7-60.3 mg, sodium hydroxide - qs for pH correction, glacial acetic acid - qs for pH correction, d / i water - up to 1904 ml.

Dosage and administration

The drug is administered intravenously.

SMOFKabiven® Peripheral is available in three 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, 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, patients with burns or in a state of severe catabolism), the need for nitrogen may be even higher.

Dose of 20-40 ml / kg / day of the drug SMOFKabiven® peripheral corresponds to 0.10-0.20 g / kg / day 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 rate of administration of the drug SMOFKabiven® peripheral should not exceed 3.0 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 40 ml / kg / day and provides the patient with nitrogen in an amount of 0. 20 g / kg / day (corresponding to 1.3 g / kg / day of amino acids), dextrose in an amount of 2.8 g / kg / day, fat in an amount of 1.1 g / kg / day and energy in an amount of 28 kcal / kg / day (which corresponds to 22 kcal / kg / day of non-protein energy).

Children

SMOFKabiven® peripheral 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.

Duration of use of the drug SMOFKabiven® peripheral usually ranges from 5 to 7 days, however, depending on the condition of the patient, it can be extended up to 3-4 weeks.

Recommendations for preparing the Biofin container for use with

1. Removing the external

package Lay 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 created pressure of the package contents! You do not need to open the horizontal partition - the contents of the chambers are easily mixed 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 you need to introduce additives (with known compatibility, for example, special preparations of vitamins, minerals, Dipeptiven), remove (break off) the cap with an 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 stand

Hang the bag on the stand (using the hole on the holder).

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 these side effects appear, the peripheral peripheral infusion of SMOFKabiven® should be discontinued, then, if necessary, the infusion can be continued at a lower rate.

To prevent the risk of an infusion rate too high, The use of a volumetric infusion pump is recommended.

Drug 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 at therapeutic doses causes a temporary release of lipoprotein lipase into the bloodstream. This may lead to increased plasma lipolysis followed by a decrease in triglyceride clearance.

Soybean oil contains Vitamin K1. However, its content in the drug SMOFKabiven® peripheral is so small that the effect on blood coagulation in patients receiving indirect anticoagulants is negligible.

Compatibility

SMOFABiven® peripheral can only be mixed with those drugs and nutrients, for which compatibility with it is confirmed (vitamins, trace elements, glutamine preparations for parenteral administration, electrolyte solutions), for example:

1. Vitalipid H adult and Vitalipid H infant

2. Soluvit H

3. Adamel H

4. Dipetvenk.

Any addition to the drug should be made under aseptic conditions. The solution is for single use only. After the infusion is complete, the remaining solution should be destroyed.

Overdose

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. Attention should be paid to possible signs of metabolic overload. Causes of impaired lipid metabolism can be genetic (individual changes in metabolism), in addition, fatty metabolism can be affected by 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 changes suddenly (for example, renal dysfunction or infectious complications develop). Fat overload syndrome is characterized by hyperlipidemia, fever, fatty liver infiltration, hepatomegaly with or without jaundice, splenomegaly, anemia, leukopenia, thrombocytopenia, coagulation disorders, hemolysis and reticulosis, violation of laboratory parameters of liver function and coma. The symptoms are usually reversible and stopped when the fat emulsion is stopped.

Introduction of large amounts of amino acids

As with other amino acid solutions, when the recommended infusion rate of SMOFKabiven® peripheral is exceeded, the amino acids contained in it may lead to undesirable effects. The development of nausea, vomiting, chills and increased sweating is possible. Amino acid infusion can also cause fever. With impaired renal function, concentrations of nitrogen-containing metabolites such as creatinine and urea may increase.

Excess dextrose administration

If the rate of dextrose infusion exceeds its clearance threshold, the patient will develop hyperglycemia.

When developing symptoms of fat or amino acid overload, the infusion of SMOFABiven® peripheral should be discontinued or reduced. There is no specific antidote for overdose of these drugs. Urgent measures for the overdose of lipids and amino acids are reduced to measures of life support with particular attention to the respiratory and cardiovascular systems. In addition, careful biochemical monitoring and treatment of specific metabolic disorders should be performed.

In the event of hyperglycemia, therapy should be carried out according to the clinical situation by prescribing short-acting insulin and / or adjusting the infusion rate of the SMOFKabiven® peripheral drug. In addition, overdose can lead to fluid overload, electrolyte imbalance and hyperosmolar state. In rare cases, if these symptoms are severe, consider hemodialysis, hemofiltration, or hemodiafiltration.

Storage conditions

At a temperature not exceeding 25 ° C. Do not freeze. Store in 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.

To ensure microbiological safety, the mixture should be used immediately after mixing the contents of the cameras.

If it is impossible to use SMOFKabiven® peripheral immediately after mixing the chambers, the Expiration of the drug 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.

For microbiological safety, the mixture should be used as soon as additives are administered.

If it is impossible to use SMOFKabiven® peripheral immediately after mixing with additives, the Expiration of the drug should not exceed 24 hours at a temperature of 2 ° to 8 ° C.

Deystvuyuschee substances

amino acids for parenteral POWER

Pharmacy leave conditions

Prescription

dosage form

dosage form

infusion solution

Fresenius Kabi, Germany



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