Composition, form of production and packaging
Emulsion for infusion (after mixing the contents of 3 chambers).
I chamber - 5.5% solution of amino acids with electrolytes - a clear, colorless or light yellow liquid.
Solution for infusion 400 ml
L-alanine 4.56 g
L-arginine 2.53 g
glycine 2.27 g
L-Histidine 1.06 g
L-isoleucine 1.32 g
L-Leucine 1.61 g
L-lysine (in the form of the hydrochloride salt) 1.28 g (1.6 g)
L-methionine 880 mg
L-phenylalanine 1.23 g
L-proline 1.5 g
L-serine 1.1 g
L-threonine 920 mg
L-tryptophan 400 mg
L-Tyrosine 90 mg
L-valine 1.28 g
sodium acetate trihydrate 980 mg
sodium glycerophosphate pentahydrate 2.14 g
potassium chloride 1.19 g
magnesium chloride hexahydrate 450 mg
Auxiliary substances: acetic acid - qs, water d / u - up to 1 liter.
II chamber - 20% solution of dextrose (glucose) with calcium chloride - a clear, colorless or light yellow liquid.
Solution for infusion 400 ml
dextrose (in the form of monohydrate) 80 g (88 g)
calcium chloride dihydrate 300 mg
Auxiliary substances: hydrochloric acid - qs, water d / u - up to 1 l.
III chamber - 10% lipid emulsion - homogeneous liquid of white or almost white color.
Emulsion for infusions 200 ml
mixture of olive and soybean oils * 20 g
* A mixture of purified olive oil (80%) and soybean oil (20%).
Auxiliary substances: egg lecithin purified - 1.2 g, glycerol - 2.25 g, sodium oleate - 30 mg, sodium hydroxide - qs, water d / u - up to 1 l.
After mixing the contents of the three sections, the resulting mixture is a white emulsion and contains:
1 l 1.5 l 2 l
nitrogen (g) 3.6 5.4 7.3
amino acids (g) 22 33 44
total calories (kcal) 610 910 1215
non-protein calories (kcal) 520 780 1040
carbohydrate calories (kcal) 320 480 640
fatty calories (kcal) 200 300 400
ratio non-protein calories / nitrogen (kcal / g N) 144 144 144
sodium (mmol) 21 32 42
potassium (mmol) 16 24 32
magnesium (mmol) 2.2 3.3 4.4
calcium (mmol) 2 3 4
phosphates (mmol) 8.5 13 17
acetates (mmol) 30 46 61
chlorides (mmol) 33 50 66
pH 6 6 6
osmolarity (mOsmol / l) 750 750 750
1 l (400 ml + 400 ml + 200 ml) - three-chamber containers (6) - cardboard boxes.
1.5 l (600 ml + 600 ml + 300 ml) - three-chamber containers (4) - cardboard boxes.
2 l (800 ml + 800 ml + 400 ml) - three-chamber containers (4) - cardboard boxes.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2010.
PHARMACHOLOGIC EFFECT
The three-component mixture is designed to maintain protein and energy metabolism. The source of organic nitrogen is L-amino acids, dextrose and fatty acids serve as an energy source. In addition, the mixture contains electrolytes.
Moderate content of essential fatty acids (EFA) in the mixture increases the content of higher EHF derivatives in the body, making up for their deficiency.
Olive oil contains a significant amount of ОІ-tocopherol, which, in combination with a small amount of PUFA, increases the vitamin E content in the body and reduces lipid peroxidation.
PHARMACOKINETICS
Ingredients of the emulsion for infusion (amino acids, electrolytes, dextrose, lipids) are metabolized and withdrawn from the body in the same way as when they are assigned 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, and they decompose faster under the action of lipoprotein lipase.
The particle size of the lipid emulsion in the mixture approaches the size of the chylomicrons, so they have a similar elimination rate.
INDICATIONS
- parenteral nutrition in adults and children over the age of 2 years in those cases when enteral nutrition is impossible, insufficient or contraindicated.
DOSING MODE
In / in through the central or peripheral vein.
The dose of the drug and the duration of the appointment are determined by the need for parenteral nutrition in each individual patient, depending on his 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 40 ml / kg of body weight (equivalent to 0.88 g of amino acids, 3.2 g of dextrose and 0.8 g of lipids per kg of body weight), i.e. 2800 ml of an emulsion for infusion to a patient having a body weight of 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 100 ml / kg of body weight (equivalent to 2.2 g of amino acids, 8 g of dextrose and 2 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.
Maximum infusion rate: the infusion rate should not exceed 3 ml / kg / h, i.e. 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.
Mode of application
A. Opening the package.
1.Razovat protective shell.
2.After opening the protective cover, discard the sachet with the oxygen-absorbing substance (if any),
3. Ensure the integrity of the container and partitions between the cameras.
4. Use only if the container is not damaged and the integrity of the partitions between the chambers is not broken (ie the contents of the three chambers were not mixed), while the amino acid and dextrose solutions should be transparent and the emulsion homogeneous.
B. Mixing of solutions and emulsions .
1. Ensure that the preparation has an ambient temperature at the time of destruction of the partitions between the chambers.
2. Manually rotate the top of the container (for which it is suspended) around its axis.
3. 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. Stir by turning the container (at least 3 times).
C. Preparation for infusion.
1. Aseptic conditions must be observed.
2.Ship the container.
3.Remove the plastic fuse from the site of the future outlet.
4. Attach the infusion system to this place.
D. Simultaneous administration of other nutrients.
Any additional nutrients (including vitamins) can be added to the finished mixture.
Vitamins can also be added to the chamber with a solution of dextrose before mixing the contents of the chambers.
Oliklinomel can be supplemented with the following components:
- electrolytes: the stability of the emulsion is preserved by adding no more than 150 mmol of sodium, 150 mmol of potassium, 5.6 mmol of magnesium and 5 mmol of calcium / 1 liter of the final mixture;
- Organic phosphates: stability of the emulsion is maintained when adding up to 15 mmol / 1 container;
- trace elements and vitamins: the stability of the emulsion is preserved by adding doses not exceeding daily allowances.
The addition of micronutrients should be performed under aseptic conditions by injecting micronutrients through a special port.
1.Prepare the port of the container.
2.Polkot port and enter a solution of micronutrients.
3. Mix the added substances with the contents of the container.
D. Rules for the administration of the drug.
If Oliklinomel was stored at a low temperature, before using it, make sure that the preparation is heated to room temperature.
Enter the drug should be 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 lipids contained in Oliklinomel from the bloodstream can cause fat overload syndrome , which can be caused by overdose or occur at the beginning of infusion, which is accompanied by a sudden deterioration in the patient's condition. The syndrome of fatty overload 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
- severe renal failure in the absence of the possibility of hemofiltration or dialysis;
severe hepatic impairment;
- congenital disorders of amino acid metabolism;
- severe blood clotting disorders;
- severe hyperlipidemia;
- hyperglycemia;
- disturbances of electrolyte metabolism, an increased concentration in the plasma of one of the electrolytes included in the mixture;
- lactic acidosis;
- pulmonary edema, hyperhydration, decompensated heart failure and hypotonic dehydration;
- unstable conditions (for example, severe post-traumatic conditions, decompensated diabetes mellitus, acute phase of hypovolemic shock, acute phase of myocardial infarction, severe metabolic acidosis, severe sepsis, hyperosmolar coma);
- Children's age is younger than 2 years;
- Hypersensitivity to the components of the drug.
With caution : patients with increased osmolarity of plasma, adrenal insufficiency, heart failure and pulmonary pathology.
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
Contraindicated:
- severe renal failure in the absence of the possibility of hemofiltration or dialysis.
A regular clinical and biochemical examination should be carried out in the following cases:
- with renal failure, especially if there is hyperkalemia; risk of occurrence or strengthening of metabolic acidosis and hyperaemia, if there is no possibility of haemofiltration or dialysis.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated:
severe hepatic insufficiency.
A regular clinical and biochemical 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.
APPLICATION FOR CHILDREN
Contraindicated in children up to 2 years.
Children over the age of 2:
The average requirement for organic nitrogen is 0.35-0.45 g / kg / day (approximately 2-3 gm / 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.
Contraindicated in children under 2 years.
Special instructions for 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.
The maximum daily dose is 100 ml / kg of body weight (equivalent to 2.2 g of amino acids, 8 where the cysts and 2 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.
Maximum infusion rate: the infusion rate should not exceed 3 ml / kg / h, i.e. 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.
SPECIAL INSTRUCTIONS
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 infusion and to 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.
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 infusion should not exceed 3 mmol / l. Their concentration should be measured no earlier than 3 hours after the start of 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, serum purification (elimination of lipids) should occur less than 6 hours after stopping the infusion of the lipid emulsion. The next infusion should be performed only after the concentration of triglycerides in the plasma is normalized.
A regular clinical and biochemical 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 failure, especially if there is hyperkalemia; risk of appearance or enhancement of metabolic acidosis and hyperazotemia in the absence of the possibility of haemofiltration or dialysis;
- diabetes mellitus: control of glucose concentration, glucosuria, ketonuria and, if possible, correction of insulin dose;
- coagulation disorders;
- Anemia;
- Hyperlipidemia (because in the emulsion there are lipids).
With prolonged use (several weeks), you should closely monitor blood tests and clotting factors.
Special instructions for 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: hypervolemia, acidosis, nausea, vomiting, trembling, electrolyte imbalance in case of an overdose and / or at an injection rate exceeding the recommended one. 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 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
Emulsion for infusion should not be administered simultaneously with blood products through the same catheter because of the possibility of pseudoagglutination.
If the blood sampling was performed before the lipids were eliminated from the plasma (usually 5-6 hours after the emulsion was stopped), the lipids contained in the emulsion may affect the results of some laboratory tests, for example, they can change the bilirubin, lactate dehydrogenase, oxygen saturation, hemoglobin.
TERMS OF RELEASE FROM PHARMACY
Only for stationary use.
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.
After mixing, the emulsion is stable for 7 days from 2 В° to 8 В° C, followed by storage for up to 48 hours at a temperature of no higher than 25 В° C. Do not use after the expiry date printed on the carton.
