Oliklinomel N4-550 E - instructions for use, dose, side effects, contraindications

Active substances	Camera with	Camera with	Camera with
	lipid	solution	solution
	emulsion	amino acids	dextrose
	(200 ml)	(400 ml)	(400 ml)
Olive and bean soybean oils	20.00 g
mixture*
L-alanine		4.56 g
L-arginine		2.53 g
Glycine		2.27 g
L-cystidine		1.06 g
L-isoleucine		1.32 g
L-leucine		1.61 g
L-lysine (in the form of		1.28 g
lysine hydrochloride)		(1.60 g)
L-methionine		0.88 g
L-phenyl alanine		1.23 g
L-proline		1.50 g
L-serine		1.10 g
L-treonine		0.92 g
L-tryptophan		0.40 g
L-tyrosine		0.09 g
L-valin		1.28 g
Sodium acetate trihydrate		0.98 g
Sodium glycerophosphate pentahydrate		2.14 g
Potassium chloride		1.19 g
Magnesium chloride hexahydrate		0.45 g
Dextrose anhydrous (in the form of			80.0 grams
dextrose monohydrate)			(88.0 g)
Calcium chloride dihydrate			0.30 g
Excipients
Egg white lecithin	1.20 g
Glycerol	2.25 g
Sodium oleate	0.03 g
Sodium hydroxide	q.s.pH
Acetic acid		q.s.pH
Hydrochloric acid			q-s-rn
Water for injections	up to 1000 ml

* - Mixture of peeled olive oil (80%) and soybean oil (20%).

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

	1000 ml	1500 ml	2000 ml	2500 ml
Nitrogen (g)	3,6	5,4	7,3	9,1
Amino acids (g)	22	33	44	55
Total calories (kcal)	610	910	1215	1520
Non-protein calories (kcal)	520	780	1040	1300
Carbohydrate calories (kcal)	320	480	640	800
Fatty calories (kcal)	200	300	400	500
Proportion of non-protein calories / nitrogen (kcal / g N)	144	144	144	144
Sodium (mmol)	21	32	42	53
Potassium (mmol)	16	24	32	40
Magnesium (mmol)	2,2	3,3	4,4	5,5
Calcium (mmol)	2	3	4	5
Phosphates (mmol)	8,5	13	17	21
Acetates (mmol)	30	46	61	76
Chlorides (mmol)	33	50	66	83
pH	6	6	6	6
Osmolarity (mOsmol / l)	750	750	750	750

Description:

Amino acid solutions and dextrose have the form of clear, colorless or light yellow liquids; The lipid emulsion has the form of a homogeneous liquid of white or almost white color.

After mixing the contents of the three sections, the resulting mixture is a white emulsion

Pharmacotherapeutic group:nutrition parenteral remedy

ATX: & nbsp

B.05.B.A Solutions for parenteral nutrition

Pharmacodynamics:

The three-component mixture is designed to maintain protein and energy metabolism. The source of organic nitrogen is L- amino acid, as an energy source dextrose and fatty acids. 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 alpha-tocopherol, which in combination with a small amount of PUFA, increases the amount of vitamin E in the body and reduces lipid peroxidation.

Pharmacokinetics:

Ingredients of the emulsion for infusions (amino acids, electrolytes, dextrose, lipids) are metabolized and removed from the body in the same way as when they are assigned 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, and they decompose faster under the action of lipoprotein lipase.

The particle size of the lipid emulsion in the mixture of Oliklinomel is close to the size of chylomicrons, so they have a similar elimination rate.

Indications:

Oliklinomel N4-550E It is used for parenteral nutrition in adults and children over 2 years of age in those cases when enteral nutrition is impossible, insufficient or contraindicated.

Contraindications:

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

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

- congenital disorders of amino acid metabolism;

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

- severe hyperglycemia;

- pathologically high concentration of sodium, potassium, magnesium, calcium and / or phosphorus in the plasma.

Carefully:

With caution: patients with increased plasma osmolarity, adrenal insufficiency, hepatic insufficiency, heart failure, pulmonary pathology, endocrine and metabolic disorders, with blood coagulation disorder and anemia. It is necessary to carefully monitor the hemogram and the coagulation parameters.

Pregnancy and lactation:

Currently, there is 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 CENTRAL OR PERIPHERAL VIENNA.

The dose of the drug and the duration of application are determined by the need for parenteral nutrition in each individual patient, depending on its condition.

Adults

Need

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

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, 0.84 mmol of sodium and 0.64 mmol of potassium per kg of body weight) e. 2800 ml emulsion for infusion to a patient with a body weight of 70 kg.

Children over the age of 2

Studies in children were not conducted.

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 range from 60 to 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 100 ml / kg of body weight (equivalent to 2.2 g of amino acids, 8 g of dextrose and 2 g of lipids, 2.1 mmol of sodium and 1.6 mmol of potassium 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 / 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.

The recommended duration of infusion is 12 to 24 hours.

The rate of administration should be adjusted to take into account the dose of the drug, the characteristics of the infusion mixture, the daily requirement for administration and the duration of the infusion.

In general, the speed should be gradually increased during the first hour.

Mode of application

A. Opening of the package

- Break the protective sheath.

- After opening the protective cover, discard the sachet with absorbent oxygen (if there is).

- Make sure the integrity of the container and partitions between the cameras.

- Use only if the container is not damaged and the integrity of the partitions between the cameras is not breached (ie,the contents of the three chambers were not mixed), while the solutions of amino acids and dextrose 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 destruction of the partitions between the chambers.

- 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 over (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 an infusion system to this place.

D. Simultaneous administration of other nutrients

In a ready mix it is supposed to add additional nutrients (in that number vitamins). In a chamber with a solution of dextrose before mixing the contents of the chambers, it is also possible to add vitamins.

Oliklinomel can be supplemented with the following components:

- Electrolytes: 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 per 1 liter of the final mixture.

-Organic phosphates: the stability of the emulsion is preserved by adding up to 15 mmol per container.

- Microelements and vitamins: the stability of the emulsion is preserved by the addition of therapeutic doses (containing up to 1 mg of iron).

The addition of micronutrients should be performed by qualified personnel in aseptic conditions by introducing micronutrients through a special port.

- Prepare the container port.

- Puncture the port and inject a solution of micronutrients.

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

E. Rules for the administration of the drug

- If Oliklinomel was stored at a low temperature, before using it, make sure that the preparation is 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.

- For single use only.

- Use container contents immediately after opening.Do not store the open container until the next infusion.

- Do not connect the container partially used. To avoid air embolism due to the content of residual gas in the main container, do not connect the containers in series.

- Unused product, waste and disposable equipment must be disposed of.

Side effects:

Undesirable effects can result from improper use of the drug (eg, overdose or too rapid administration).

Below are the data on adverse reactions (HP) that were recorded in clinical trials involving 64 patients and during the post-marketing use of the drug. HP are grouped by systems and bodies according to the MedDRA dictionary and are listed below in order of decreasing severity. The frequency of HP was assessed using the following scale: very often (> 1/10), often (> 1/100 to <1/10), infrequently (> 1/1000 to <1/100), rarely (> 1 / 10000 to <1/1000), very rarely (<1/10000), the frequency is unknown (it is impossible to determine based on available data).

Immune system disorders: often - hypersensitivity reactions; frequency unknown - bronchospasm (as one of the symptoms of an allergic reaction).

Disturbances from the nervous system: often - headache; frequency is unknown - tremor.

Disorders from the gastrointestinal tract: often - diarrhea; frequency unknown - abdominal pain, nausea, vomiting.

Disorders from the kidneys and urinary tract: often - azotemia.

Disorders from the liver and bile ducts: the frequency is unknown - cholestatic hepatitis, cholestasis, jaundice.

Disturbances from the skin and subcutaneous tissues: the frequency is unknown - erythema, hyperhidrosis.

Disorders from the musculoskeletal and connective tissue: the frequency is unknown - pain in the muscles and bones, back pain, chest pain, pain in the extremities, muscle spasm.

General disorders and disorders at the injection site: often - chills, extravasation, pain at the infusion site, edema, blistering at the injection site; frequency unknown - phlebitis at the site of catheter placement, local edema, localized edema, peripheral edema, fever, heat, hyperthermia, general malaise, inflammation.

Changes in laboratory indicators: often - increased activity in the blood plasma of liver enzymes, gamma-glutamyltransferase,increased activity of alkaline phosphatase in the blood, increased concentration of triglycerides in the blood; the frequency is unknown - an increase in the concentration in the plasma of bilirubin, an increase in the concentration of glucose in the blood, hyperglycemia.

In very rare cases, there may be a "fat overload" syndrome, which may be caused by improper use (eg, overdose and / or exceeding the recommended rate of administration). However, the manifestations of this syndrome can be observed at the beginning of infusion with the use of the drug in accordance with the instructions. Reduced ability to eliminate lipids from the bloodstream, which are part of the drug, against the background of increased plasma clearance can lead to the development of a "fat overload syndrome". The syndrome manifests itself as a sharp deterioration in the patient's condition and is characterized by such phenomena as hyperlipidemia, fever, fat liver infiltration (hepatomegaly), liver dysfunction, anemia, leukopenia, thrombocytopenia, clotting and coma, requiring hospitalization. These symptoms are reversible if the injection of the lipid emulsion is stopped.This syndrome, as a rule, is reversible upon termination of the administration of the lipid emulsion.

When used in children

In children receiving lipid infusions, thrombocytopenia is described.

The physician should instruct the patient to report any HP incidents that are not listed in the instructions, as well as the cases of HP aggravation specified in the instructions.

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 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:

No interaction studies were conducted.

Do not enter ceftriaxone simultaneously with intravenous solutions containing calcium, due to the risk of sedimentation of ceftriaxone-calcium salt.If the same infusion system is used for sequential administration, it should be thoroughly rinsed with a compatible liquid before using the next preparation.

The drug contains vitamin K, which is part of all lipid emulsions. 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. 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 necessary to check in advance the compatibility with the drug components of solutions administered simultaneously through the same system, a catheter or a cannula.

Considering that the composition of the drug is potassium and in order to prevent the development of hyperkalemia, a specialattention should be given to patients taking concomitant potassium-sparing diuretics (eg, amiloride, spironolactone, triamterene), angiotensin-converting enzyme inhibitors and immunosuppressants: ciclosporin and tacrolimus.

Emulsion for infusion should not be administered in parallel with blood products through the same catheter because of the possibility of pseudoagglutination.

The drug contains calcium ions, which increase the risk of formation of a coagulated sediment in anticoagulated (citrated, canned) blood and its components.

If the blood sampling was performed before the lipids were eliminated from the plasma (usually 5-6 hours after the emulsion was discontinued), 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.

Special instructions:

Too fast administration of a solution for parenteral nutrition (PP), including Oliklinomel N4-550E, can lead to severe consequences and death.

When there are objective or subjective manifestations of an allergic reaction(eg, sweating, fever, chills, headache, skin rash, dyspnea, bronchospasm) at the beginning of the drug, its administration should be stopped immediately. This medication contains soybean oil and egg phosphatides. Soy and egg proteins can cause hypersensitivity reactions. Cross-allergic reactions between soy and peanut proteins are described.

At the beginning of intravenous infusion, careful monitoring of the patient's condition is necessary. Before the start of infusion should be done correction of violations of water and electrolyte balance, conditions of severe volume overload and severe metabolic disorders.

Do not inject other drugs and substances into separate chambers and into the finished emulsion, without having data on the compatibility of these components and their effect on drug stability (in particular, on the stability of the lipid emulsion). Excessive addition of calcium and phosphorus can lead to the formation of calcium phosphorus precipitates. These precipitates, as well as the destabilization of the lipid emulsion, can cause the vessel to occlude.

In patients receiving PP, complications such as infection at the site of injection and sepsis are possible,which arise, in particular, with insufficient care of the catheter, due to the immunosuppressive effect of the disease or drugs. Recognize the infection at an early stage will help close monitoring of symptoms and laboratory tests for the onset of fever and chills, leukocytosis, technical problems with medical devices used for input, as well as hyperglycemia. Patients who require PP are often prone to infectious complications due to nutritional deficiencies and / or due to a condition caused by the underlying disease. The frequency of septic complications can be reduced by strictly observing aseptic measures during catheter placement, in the care of it, and also when preparing the drug for PP.

In the course of therapy necessary to control fluid and electrolyte balance, serum osmolarity, concentration of serum triglycerides, acid-base balance, the concentration of glucose in the blood, liver and kidney samples, the sample and coagulation of the blood, including the number of platelets.

If the supply of nutrients is not adapted to the needs of the patient or metabolicthe capacity of any component of the diet is not accurately determined, complications from the metabolism are possible. Unwanted metabolic phenomena may occur when an inadequate or excessive amount of nutrients is introduced, or when the composition of the finished mixture does not match the needs of a particular patient.

In the case of hyperglycemia, the rate of infusion of the drug and / or the introduction of insulin should be adjusted.

Despite the fact that the drug is allowed to enter the peripheral vein (due to low osmolarity), the development of thrombophlebitis is possible. It is necessary to examine the site of the catheter every day for signs of thrombophlebitis. 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.

With the introduction of additional nutrients, the osmolarity of the resulting mixture should be measured before the infusion begins. The resulting mixture must be administered through a central or peripheral venous catheter, depending on the final osmolarity. If the finished mixture is a hypertonic solution, when injected into the peripheral vein, it can cause irritation of the vein walls.

Although the composition of the drug includes vitamins and trace elements in the usual concentration, their content is still not enough to meet the needs of the body, so they should be added to prevent deficient conditions. The resumption of feeding of patients with severe depletion can cause a renewal syndrome, which is characterized by an intense intake of potassium, phosphorus and magnesium ions into the intracellular space, in patients the processes of anabolism improve.Possible development of thiamine deficiency and fluid retention. These complications can be avoided through careful dynamic observation and a gradual, but not excessive, increase in the intake of nutrients. This syndrome is described for similar drugs.

Liver failure

It should be used with caution in patients with hepatic insufficiency because of the risk of developing or exacerbating neurological disorders associated with hyperammonemia. It is necessary to conduct regular clinical and laboratory tests, in particular on the concentration of glucose and triglycerides in the blood, the content of electrolytes and check the biochemical parameters of liver function.

Renal insufficiency

It should be used with caution in patients with renal insufficiency, especially in the presence of hyperkalemia, because of the risk of developing or exacerbating metabolic acidosis and hyperaemiaemia, if there is no adrenal cleansing. These patients need to carefully monitor the water-electrolyte balance and the concentration of triglycerides.

Blood disorders

It should be used with caution in patients with coagulation disorder blood and anemia. Careful monitor hemogram and indicators coagulation.

Disorders from the endocrine system and metabolism

It should be used with caution in patients with the following conditions:

- metabolic acidosis. In the case of lactic acidosis, the use of carbohydrates is not recommended. Clinical and laboratory tests should be performed regularly;

- diabetes. It is necessary to control the concentration of glucose, glucosuria and ketonuria and, if necessary, adjust the doses of insulin;

- hyperlipidemia due to the lipid content of the emulsion for infusion. Clinical and laboratory tests should be performed regularly;

- disturbances in the metabolism of amino acids.

Special instructions for use in pediatrics

Studies of the drug in children have not been conducted. When choosing a dose should focus on the age of the child, protein and energy needs, attacks 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.

Effect on the ability to drive transp. cf. and fur:No data available.

Form release / dosage:

Emulsion for infusion.

Packaging:Emulsion for infusions with a total volume of 1000, 1500 and 2000 ml (10% lipid emulsion 200, 300 and 400 ml, 5.5 % solution of amino acids with electrolytes 400, 600 and 800 ml; 20% dextrose solution with calcium 400, 600 and 800 ml, respectively), placed in three isolated chambers and packed in a plastic container. 6 containers in volume of 1000 ml, 4 containers in volume 1500 and 2000 ml together with the instruction on application place in a cardboard box.

Storage conditions:

At a temperature of 2 ° to 25 ° C. Do not freeze.

Keep out of the reach of children.

Shelf life:

2 years

After mixing, the emulsion is stable for 7 days from 2 ° to 8 ° C, followed by storage for up to 48 hours at a temperature of no higher than 25 ° C.

Do not use after the expiry date printed on the carton.

Terms of leave from pharmacies:For hospitals

Registration number:LSR-005752/08

Date of registration:22.07.2008

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: & nbsp18.06.2014

Illustrated instructions

Instructions

Oliklinomel N4-550 E (Oliclinomel N4-550 E)