Composition, form of production and packaging
Emulsion for infusion (after mixing the contents of 3 chambers).
I chamber - 10% solution of amino acids with electrolytes.
1 l
L-alanine 20.7 g
L-arginine 11.5 g
glycine 10.3 g
L-Histidine 4.8 g
L-isoleucine 6 g
L-leucine 7.3 g
L-lysine (in the form of the hydrochloride) 5.8 g (7.25 g)
L-Methionine 4 g
L-phenylalanine 5.6 g
L-proline 6.8 g
L-serine 5 g
L-threonine 4.2 g
L-tryptophan 1.8 g
L-tyrosine 400 mg
L-valine 5.8 g
sodium acetate trihydrate 6.12 g
sodium glycerophosphate pentahydrate 5.36 g
potassium chloride 4.47 g
magnesium chloride hexahydrate 1.13 g
Auxiliary substances: acetic acid - qs, water d / u - up to 1 liter.
II chamber - 40% solution of dextrose (glucose) with calcium (electrolyte).
1 l
dextrose (in the form of monohydrate) 400 g (440 g)
calcium chloride dihydrate 740 mg
Auxiliary substances: hydrochloric acid - qs, water d / u - up to 1 l.
III chamber - 20% lipid emulsion.
1 l
mixture of refined olive and soybean oil 200 g
Excipients: glycerol (glycerol) - 22.5 g, egg purified phosphatides - 12 g, sodium oleate - 300 mg, sodium hydroxide - qs, water d / and - up to 1 l.
After mixing the contents of the three sections, the mixture contains:
1 l 1.5 l 2 l 2.5 liters
nitrogen (g) 6.6 9.9 13.2 16.5
amino acids (g) 40 60 80 100
dextrose (g) 160 240 320 400
lipids (g) 40 60 80 100
total caloric value (kcal) 1200 1800 2400 3000
non-protein calories (kcal) 1040 1560 2080 2600
carbohydrate calories (kcal) 640 960 1280 1600
fat calories (kcal) 400 600 800 1000
ratio non-protein calories / nitrogen (kcal / g N) 158 158 158 158
sodium (mmol) 32 48 64 80
Potassium (mmol) 24 36 48 60
magnesium (mmol) 2.2 3.3 4.4 5.5
calcium (mmol) 2 3 4 5
phosphates * (mmol) 10 15 20 25
acetates (mmol) 57 86 114 143
chlorides (mmol) 48 72 96 120
pH 6 6 6 6
osmolarity (mOsm / l) 1450 1450 1450 1450
* Including phosphates from the lipid emulsion.
1 l (400 ml + 400 ml + 200 ml) - three-chambered containers (6) - plastic bags.
1.5 l (600 ml + 600 ml + 300 ml) - three-chamber containers (4) - plastic bags.
2 l (800 ml + 800 ml + 400 ml) - three-chamber containers (4) - plastic bags.
2.5 l (1000 ml + 1000 ml + 500 ml) - three-chamber containers (2) - plastic bags.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
PHARMACHOLOGIC EFFECT
The drug for parenteral nutrition. The three-component mixture is designed to maintain protein and energy metabolism.
Characteristics of the preparation
Amino acid profile:
- Essential acids / all amino acids: 40.5%;
- essential amino acids (g) / total nitrogen: 2.5;
- branched chain amino acids / total amino acid content: 19%.
The source of carbohydrates is dextrose (160 g / l).
Lipid emulsion is a mixture of refined olive oil and refined soybean oil (in a ratio of 80:20). The approximate percentage of fatty acids in it:
- 5% saturated fatty acids (NLC);
- 65% of monounsaturated fatty acids (MUFA);
- 20% polyunsaturated essential fatty acids (PUFA).
The ratio of phospholipids and triglycerides is 0.06.
The source of organic nitrogen is L-amino acids, dextrose (glucose) and essential fatty acids serve as an energy source.
In addition, the mixture contains electrolytes. The amino acid solution contains 15 L-amino acids (including 8 essential amino acids) that, when administered iv, enter the systemic circulation (ie, completely bioavailable). Amino acids play both a structural and regulatory role in the body. They are required for the synthesis of proteins, and they are also a source of energy.
Olive oil included in the preparation contains a significant amount of alpha-tocopherol, which in combination with a small amount of PUFA promotes the production of vitamin E in the body and reduces lipid peroxidation.
Moderate in the preparation of essential fatty acids increases the level of higher derivatives of fatty acids in the body, making up for their deficiency.
PHARMACOKINETICS
Components of the emulsion for infusions (amino acids, electrolytes, dextrose, lipids) are distributed, metabolized and excreted from the body in the same way as when they are used separately.
The pharmacokinetic properties of amino acids injected in / in basically coincide with the properties of amino acids supplied by natural (enteral) nutrition (however in this case the amino acids derived from food proteins pass through the liver before entering the systemic bloodstream).
The rate of elimination of lipid emulsion particles depends on their size. Small lipid particles are released more slowly, while they are more quickly cleaved by the action of lipoprotein lipase.
The particle size of the lipid emulsion in the mixture of Oliklinomel N7-1000E is close to the size of chylomicron, therefore they have a similar elimination rate.
INDICATIONS
- for parenteral nutrition in adults and children over the age of 2 years, in cases where oral or enteral nutrition is impossible, insufficient or contraindicated.
DOSING MODE
The drug is administered IV in the central vein.
The dose of the drug and the duration of the appointment are determined by the need for parenteral nutrition in each patient, depending on its condition.
Adults
The average requirement for organic nitrogen is 0.16-0.35 g / kg / day (approximately 1-2 g of amino acids / kg / day). Energy needs vary depending on the patient's condition and intensity of catabolic processes. On average, they are 25-40 kcal / kg / day.
The maximum daily dose is 36 ml / kg of body weight (equivalent to 1.44 g of amino acids, 5.76 g of dextrose and 1.44 g of lipids per kg of body weight), i.e. 2520 ml emulsion for infusion to a patient weighing 70 kg.
Children over the age of 2
The average requirement for organic nitrogen is 0.35-0.45 g / kg / day (approximately 2-3 g of amino acids / kg / day). Energy needs vary depending on the age, the condition of the patient, and the intensity of catabolic processes. On average, they are 60-110 kcal / kg / day.
The dose depends on the amount of fluid that has entered the body and the daily requirement of protein. In this case, the state of water exchange should be taken into account.
The maximum daily dose is 75 ml / kg of body weight (equivalent to 3 g of amino acids, 12 g of dextrose and 3 g of lipids per kg of body weight). As a rule, do not exceed the dose of 3 g / kg / day of amino acids and / or 17 g / kg / day of dextrose and / or 3 g / kg / day of lipids, except in special cases. The infusion rate should not exceed 1.5 ml / kg / h, i.Рµ. not more than 0.06 g of amino acids, 0.24 g of dextrose and 0.06 g of lipids per kg of body weight / h.
Application rules
Opening of the package
Break the protective sheath. After opening the containment, discard the container with oxygen-absorbing material (if any). Make sure the integrity of the container and partitions between the sections. Use only if the container is not damaged and the integrity of the partitions between the sections is not broken (ie the contents of the three sections were not mixed), while the solutions of amino acids and glucose should be transparent, and the emulsion - homogeneous.
Mixing of solutions and emulsions.
Make sure that the preparation has an ambient temperature at the time of the destruction of the partitions between the sections. Manually turn the top of the container (for which it is suspended) around its axis. The partitions will disappear from the side of the future inlet. Continue to twist the tip until the septa open for at least half of their length. Move by turning the container (at least 3 times).
Preparation for infusion
Aseptic conditions must be met. Suspend the container. Remove the plastic fuse from the site of the future outlet located in the section with a solution of amino acids. Attach the infusion system to this place.
Simultaneous administration of other nutrients
Any additional nutrients (including vitamins) can be added to the finished mixture. Vitamins can also be added to the glucose solution section before the contents of the sections are mixed.
Oliklinomel N7-1000 E can be supplemented with the following components:
- electrolytes: the stability of the emulsion was maintained when not more than 150 mmol of sodium, 150 mmol of potassium, 5.6 mmol of magnesium and 5 mmol of calcium per 1 liter of the final mixture were added;
- Organic phosphates: the stability of the emulsion was maintained by adding up to 15 mmol per package;
- trace elements and vitamins: the stability of the emulsion was preserved by adding doses not exceeding daily allowances.
The addition of micronutrients should be performed under aseptic conditions by injecting micronutrients into the container through a special port located in the section with glucose solution. For this it is necessary to prepare a puncture site; pierce the container at this point and introduce a solution of micronutrients; mix the added substances with the contents of the package.
Rules of drug administration
If Oliklinomel N7-1000 E was stored at a low temperature, before using it, make sure that the preparation has warmed to room temperature. Enter the drug should only after the integrity of the partitions between all three sections is broken, and their contents are mixed.
SIDE EFFECT
Possible side effects: hyperthermia, sweating, tremor, nausea, headache, respiratory failure.
Also, there was sometimes a temporary increase in the concentration of biochemical markers of liver function (such as alkaline phosphatase, transaminase, bilirubin), especially with prolonged use of parenteral nutrition (several weeks). In rare cases, hepatomegaly and jaundice developed.
Reduced ability to eliminate blood lipids contained in Oliklinomel N7-1000E, can cause a "fat overload syndrome", which can be caused by overdose or occur at the beginning of infusion; accompanied by a sudden deterioration of the patient. "Fatigue Syndrome Syndrome" is characterized by: hyperlipidemia, fever, fatty liver infiltration, hepatomegaly, anemia, leukopenia, thrombocytopenia, coagulation disorders and coma. These symptoms are reversible if the infusion of the lipid emulsion is suspended.
There have also been reports of rare cases of thrombocytopenia in children receiving lipid emulsion infusions.
The drug contains soybean oil, which can cause a severe allergic reaction (rarely).
Infusion should be discontinued immediately as soon as any symptoms of an allergic reaction appear (such as fever, shivering, skin rash, respiratory failure).
CONTRAINDICATIONS
- renal failure of severe degree in the absence of the possibility of hemofiltration or dialysis;
severe hepatic impairment;
- congenital disorders of amino acid metabolism;
- severe bleeding disorders;
- severe hyperlipidemia or severe disorders of lipid metabolism, characterized by hypertriglyceridemia;
- Hyperglycemia, requiring the introduction of more than 6 units. insulin / h;
- pathologically elevated concentration in plasma of sodium, potassium, magnesium, calcium and / or phosphorus;
- conditions in which volume overload is contraindicated, such as pulmonary edema, hyperhydration, decompensated heart failure;
- Children under 2 years of age (unsuitable levels of calories / nitrogen, as well as incoming energy);
- hypersensitivity to any of the active or auxiliary substances of the drug;
- Hypersensitivity to egg, soy, peanut proteins, amino acids.
PREGNANCY AND LACTATION
At present, there are no reliable data on the use of the drug in pregnant and lactating women.
In such cases, the doctor for the decision must independently assess the relationship between risk and benefit.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindication: severe renal failure in the absence of the possibility of hemofiltration or dialysis.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindications: severe hepatic impairment.
APPLICATION FOR CHILDREN
Contraindicated in childhood younger than 2 years (unsuitable levels of calories / nitrogen, as well as incoming energy).
With parenteral nutrition in children older than 2 years, it is advisable to choose the volume of the container in accordance with the daily dose.
When choosing a dose should focus on the child's age, protein and energy needs, as well as on the disease. If necessary, enterally proteins and / or "energy" components (carbohydrates, lipids) should be added.
It is necessary to add vitamins and trace elements in doses, always used in pediatrics.
SPECIAL INSTRUCTIONS
The drug should not be administered through the peripheral vein.
Correction of violations of water and electrolyte balance, as well as metabolic disorders should be done before the infusion.
Because the preparation does not contain vitamins and trace elements, then, when added, it is necessary to determine the dosages of these substances (depending on the need) before the infusions start and calculate the osmolality of the resulting solution.
Use the drug only if the container is not damaged and the integrity of the partitions between the sections is not broken (ie the contents of the three sections were not mixed), while the solutions of amino acids and glucose should be transparent, and the emulsion - homogeneous.
The drug is recommended to use immediately after opening the container. After mixing, the emulsion is stable for 7 days at a temperature of 2 В° to 8 В° C, followed by storage for up to 48 hours at a temperature of no higher than 25 В° C. Unused residue should be discarded.
During the course of treatment, monitoring of water and electrolyte balance, plasma osmolarity, acid-base status, blood glucose and functional liver tests is required.
The concentration of triglycerides in plasma and the ability to remove lipids from the bloodstream should be regularly assessed.
The concentration of serum triglycerides during infusions should not exceed 3 mmol / l. Their concentration should be measured no earlier than 3 hours after the start of the infusion.
If you suspect a disorder of lipid metabolism, it is recommended to repeat the same tests 5-6 hours after the termination of the administration of the emulsion. In adults, the "cleansing" of serum (elimination of lipids) should occur less than 6 hours after the cessation of lipid emulsion infusions. The next infusion should be performed only after the concentration of triglycerides in the plasma is normalized.
In addition, regular clinical and clinical examination should be carried out in the following cases:
- with hepatic failure - because of the risk of the appearance or strengthening of neurological disorders associated with hyperammonemia;
- with renal insufficiency, especially if there is hyperkalemia; because of the risk of the appearance or enhancement of metabolic acidosis and hyperaemia, if there is no possibility of haemofiltration or dialysis;
- with diabetes mellitus (control of glucose concentration, glucosuria, ketonuria and, if possible, correction of insulin dose);
- with violations of blood clotting;
- with anemia;
- with hyperlipidemia (because in the emulsion there are lipids).
With prolonged use (several weeks), you should closely monitor blood tests and clotting factors.
Use in Pediatrics
When choosing a dose, you should focus on the child's age, protein and energy needs, as well as on the disease. If necessary, enterally proteins and / or "energy" components (carbohydrates, lipids) should be added.
With parenteral nutrition in children older than 2 years, it is advisable to choose the volume of the container in accordance with the daily dose.
It is necessary to add vitamins and trace elements in doses, always used in pediatrics.
OVERDOSE
Symptoms: in case of an overdose and / or at an injection rate exceeding recommended, symptoms of hypervolemia, acidosis, nausea, vomiting, trembling, electrolyte imbalance are noted. When too much dextrose is administered, hyperglycemia, glucosuria and hyperosmolar syndrome may develop.
Treatment: in such cases, the infusion should be stopped immediately. Reduced ability to eliminate lipids from the bloodstream can cause a "fat overload syndrome", all of which are reversible after discontinuation of the drug. In severe cases, hemodialysis, haemofiltration or hemodiafiltration may be required.
DRUG INTERACTION
Ceftriaxone should not be administered concomitantly with / in solutions containing calcium, due to the risk of sedimentation of ceftriaxone-calcium salt.
Oliklinomel N7-1000E contains vitamin K, which is part of the lipid emulsion. When using the drug in the recommended doses, there is no reason to believe that vitamin K can in any way affect the effects of indirect anticoagulants, coumarin derivatives.
An emulsion for infusions should not be administered before, simultaneously or after the administration of blood products through the same catheter because of the possibility of pseudoagglutination.
If the blood sampling is performed before the lipids are eliminated from the plasma (usually complete elimination of lipids occurs 5-6 hours after the emulsion is discontinued), the lipids contained in the emulsion can change the concentration of bilirubin and hemoglobin, cause a deviation from the LDH norm, change the degree of saturation oxygen.
Considering that potassium is included in the preparation of Oliklinomel N7-1000E, special attention should be paid to patients taking potassium-sparing diuretics (for example, amiloride, spironolactone, triamterene), ACE inhibitors and immunosuppressants, cyclosporin and tacrolimus, in order to prevent the development of hyperkalemia.
Before the addition of other drugs or agents to one of the three chambers or the prepared mixture, it is necessary to check the compatibility of the injected substances with the components of the preparation, as well as the stability of the resulting mixture (especially the lipid emulsion). Incompatibility can be caused by such factors as increased acidity (low pH values) or inappropriate concentrations of bivalent cations (Ca 2+ and Mg 2+ ), which can destabilize the lipid emulsion.
It is also worthwhile to check in advance the compatibility with the drug components of solutions administered simultaneously through the same catheter.
Excessive addition of iron to the drug may lead to destabilization of the lipid emulsion. Iron should not be added to the drug if the stability of the drug is not confirmed.
Excessive addition of calcium and phosphorus can lead to the formation of calcium phosphorus precipitates, which can lead to vessel occlusion.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of 2 В° to 25 В° C; Do not freeze. Shelf life - 2 years.
