Oliklinomel N7-1000E - instructions for use, dose, side effects, contraindications

Ingredient name	Amount, g / l
Active substances
L-alanine	20,70
L-arginine	11,50
Glycine	10,30
L-cystidine	4,80
L-isoleucine	6,00
L-leucine	7,30
L-lysine (as hydrochloride)	5,80 (7,25)
L-methionine	4,00
L-phenylalanine	5,60
L-proline	6,80
L-serine	5,00
L-treonine	4,20
L- tryptophan	1,80
L-tyrosine	0,40
L-valin	5,80
Sodium acetate trihydrate	6,12
Sodium glycerophosphate pentahydrate	5,36
Potassium chloride	4,47
Magnesium chloride hexahydrate	1,13
Auxiliary matter
Acetic acid	q.s.
Water for injections	up to 1000 ml
b) 40% glucose solution with calcium
Ingredient name	Amount, g / l
Active substances
G of lucosis (dextrose) (as glucose monohydrate)	400,00 (440,00)
Calcium chloride dihydrate	0,74
Auxiliary matter
Acid hydrochloric	q.s.
Water for injections	up to 1000 ml

c) 20% lipid emulsion

Ingredient name	Amount, g / l
Active substances
Refined soybean oil + refined olive oil	200.00 g
Auxiliary matter
Egg-Egg Phosphatides, Peeled	12.00 g
Glycerol (glycerol)	22.50 g
Sodium oleate	0.30 g
Sodium hydroxide	q.s.
Water for injections	up to 1000 ml

After mixing the contents of the three sections, the mixture contains:

	1000 ml	1500 ml	2000 ml	2500 ml
Nitrogen (g)	6,6	9,9	13,2	16,5
Amino acids (g)	40	60	80	100
Dextrose (d)	160	240	320	400
Lipids (g)	40	60	80	100
Total calories (kcal)	1200	1800	2400	3000
Non-protein calories (kcal)	1040	1560	2080	2600
Carbohydrate calories (kcal)	640	960	1280	1600
Fatty calories (kcal)	400	600	800	1000
As the 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
Osmolar ity (mOsm / L)	1450	1450	1450	1450

* Including phosphates from lipid emulsion

Description:

The amino acid solution is clear, colorless or light yellow, The glucose solution is clear, colorless or light yellow in color,

Lipid homogeneous emulsion of white or almost white color.

Pharmacotherapeutic group:Parenteral nutrition

ATX: & nbsp

B.05.B.A Solutions for parenteral nutrition

Pharmacodynamics:

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 %

- irreplaceable 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:

-15% saturated fatty acids (NLC);

-65% of monounsaturated fatty acids (MUFA);

-20% of polyunsaturated essential fatty acids (PUFA).

The ratio of phospholipids and triglycerides is 0.06.

The source of organic nitrogen is L-amino acids, the energy source is the dextrose(glucose) and essential fatty acids.

In addition, the mixture contains electrolytes.

The amino acid solution contains 15 L-amino acids (including 8 essential amino acids) that, when administered intravenously, fall directly into 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 polyunsaturated essential fatty acids, contributes to 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 infusion (amino acids, glucose, lipids, electrolytes) 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 intravenously 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 approaches the size of chylomicron, so they have a similar elimination rate.

Indications:

For parenteral nutrition in adults and children over the age of 2 years in those cases when feeding through the mouth or enteral nutrition is impossible, insufficient or contraindicated.

Contraindications:

- age under 2 years (unsuitable levels of calories / nitrogen, as well as incoming energy);

- hypersensitivity to egg, soy, peanut proteins, amino acids, or to any of the active or auxiliary substances of the drug;

- severe renal failure in the absence of hemofiltration or dialysis;

- severe hepatic impairment;

- congenital disorders of amino acid metabolism;

- severe bleeding disorders;

- severe hyperlipidemia or severe lipid metabolism, characterized by hypertriglyceridemia;

- Hyperglycemia, requiring the administration of more than 6 units. insulin / h;

- pathologically elevated concentration in plasma of sodium, potassium, magnesium, calcium and / or phosphorus;

- conditions in which a volume overload is contraindicated, such as pulmonary edema, hyperhydration, decompensated heart failure.

Carefully:

With caution to patients with increased plasma osmolarity, 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.

Dosing and Administration:

Intravenously through the central 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

Need

The average requirement for organic nitrogen is 0.16-0.35 g / kg / day (approximately 1-2 g of amino acid / 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

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

Need

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

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.

Maximum infusion rate: the infusion rate should not exceed 1.5 ml / kg / hour, 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 per hour.

Mode of application

A. Opening of the package

- Break the protective sheath.

- After opening the containment, discard the container with absorbent material oxygen (if there is).

- 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 amino acid and dextrose solutions should be transparent and the emulsion homogeneous.

B. 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. Stir by turning the container (at least 3 times).

C. Preparation for infusion

Aseptic conditions must be met.

- Suspend the container.

- Remove the plastic fuse from the site of the future outlet.

- 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 section with a dextrose solution before the contents of the sections are mixed.

Oliklinomel can be supplemented with the following components:

- Electrolytes: the stability of the emulsion was maintained by the addition of 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.

- Organic phosphates: the stability of the emulsion was maintained by adding up to 15 mmol per pack.

- Microelements and vitamins: the stability of the emulsion was preserved by the addition of doses not exceeding daily allowances.

The addition of micronutrients should be performed under aseptic conditions by injecting micronutrients into the container (via the injection needle):

- Prepare a puncture site,

- Puncture in this place the container and enter a solution of micronutrients,

- Mix the added substances with the contents of the package.

E. Rules for the administration of the drug

- If Oliklinomel was stored at a low temperature, before using it, make sure that the preparation has warmed 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 effects:

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, transaminases, bilirubin), especially with prolonged use of parenteral nutrition (several weeks).

In rare cases, hepatomegaly and jaundice developed.

The reduced ability to eliminate lipids contained in Oliklinomel from the bloodstream can cause a "fat overload syndrome", which can be caused by an overdose or may occur at the onset of infusion; accompanied by a sudden deterioration of the patient."Fatty overload 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, tremors, skin rashes, and breathing problems).

Overdose:

Symptoms of 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 a "fat overload syndrome", all of which are reversible after discontinuation of the drug administration.

In severe cases, hemodialysis, haemofiltration or hemodiafiltration may be required.

Interaction:

Ceftriaxone should not be administered concomitantly with intravenous solutions containing calcium, due to the risk of sedimentation of ceftriaxone-calcium salt. OLIKLINOMEL N 7-1000E 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, at the same time, or after administration of blood products through the same catheter due to the possibility of pseudoagglutination.

If blood sampling is performed before the lipids are eliminated from the plasma (usually complete elimination of lipids occurs 5 to 6 hours after the emulsion is stopped), the lipids contained in the emulsion can alter the concentration of bilirubin and hemoglobin, the rate of lactate dehydrogenase, and the degree of oxygen saturation.

Given that the composition of the drug OLIKLINOMEL N 7-1000E is potassium and to prevent the development of hyperkalemia, special attention should be paid to patients taking potassium-sparing diuretics simultaneously (for example, amiloride, spironolactone, triamterene), ACE inhibitors (angiotensin-converting enzyme), and immunosuppressants ciclosporin and tacrolimus.

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 (Ca2 + and Mg2 +), 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 phosphate precipitates, which can lead to vessel occlusion.

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.

Since the drug does not contain vitamins and trace elements, when added, it is necessary to determine the dose of these substances (depending on the need) before the infusion is started 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.

The drug should be used immediately after opening the container and should not be stored for the next infusion.

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 the infusion.

If you suspect a disorder of lipid metabolism, it is recommended to repeat the same tests 5-6 hours after stopping the administration of the emulsion. In adults, the "cleansing" of serum (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.

In addition, regular clinical and clinical examination should be carried out in the following cases:

With hepatic failure - due to the risk of the appearance or strengthening of neurological disorders associated with hyperammonemia.

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.

Diabetes mellitus: control of glucose concentration, glucosuria, ketonuria and, if possible, dose adjustment for insulin.

Violations of blood clotting.

Anemia.

Hyperlipidemia (because there are lipids in the emulsion)

With prolonged use (several weeks), you should closely monitor blood tests and clotting factors.

Special instructions for use in pediatrics:

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.

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.

Form release / dosage:Emulsion for infusion.

Packaging:

Primary packaging: three components of the preparation, the total volume of 1L, 1.5L, 2L and 2.5 L (10% solution of amino acids with electrolytes (400ml, 600ml, 800ml, 1000ml, respectively), 40% glucose solution with calcium (400ml, 600ml , 800ml, 1000ml, respectively), 20% lipid emulsion (200ml, 300ml, 400ml, 500ml)) are placed in three isolated sections of a three-chamber container; at the bottom of each chamber there is an outflow tube (port), sealed on the outside. The 3-chamber container is placed in a plastic bag

Secondary packaging for hospital: containers with instructions for use are placed in cardboard box: containers with a capacity of 1000 ml of 6 pieces; containers with a capacity of 1500ml for 4 pieces; 4 containers with a capacity of 2000 ml; 2 containers with a capacity of 2500 ml.

Storage conditions:

At a temperature of 2 - 25 ° C, do not freeze.

Keep out of the reach of children.

Shelf life:

2 years

Terms of leave from pharmacies:On prescription

Registration number:LS-000011

Date of registration:19.02.2010

The owner of the registration certificate:Baxter, C.A.Baxter, C.A. Belgium

Manufacturer: & nbsp

BAXTER, S.A. Belgium

Representation: & nbspBaxter Baxter USA

Information update date: & nbsp26.06.2013

Illustrated instructions

Instructions

Oliklinomel N7-1000E (Oliclinomel N7-1000E)