IONOCHES - instructions for use, dose, side effects, contraindications

Component name	Concentration
	6%	10%
Active substances:
Hydroxyethyl starch with an average a molecular weight of 130,000 Da and a degree of substitution of 0.4	- 60.0 g	- 100.0 g
Sodium chloride	- 6.250 g	- 6.250 g
Potassium chloride	- 0.300 g	- 0.300 g
Calcium chloride hexahydrate (corresponding to 0.279 g calcium chloride)	- 0.551 g	- 0.551 g
Magnesium chloride hexahydrate (corresponding to 0.094 g magnesium chloride)	- 0.200 g	- 0.200 g
Sodium acetate trihydrate (corresponding to 1.971 g sodium acetate)	- 3.270 g	- 3.270 g
Apple acid	- 0.670 g	- 0.670 g
Excipients:
Sodium hydroxide	- 0.375 g	- 0.375 g
A solution of hydrochloric acid 1 M or sodium hydroxide solution 1 M	- to pH 5.0-7.0
Water for injections	- up to 1 liter	- up to 1 liter
Concentration of electrolytes:
Sodium	- 140.0 mmol / l
Potassium	- 4.0 mmol / l
Calcium	- 2.5 mmol / l
Magnesium	- 1.0 mmol / l
Chlorides	- 118.0 mmol / l
Acetates	- 24.0 mmol / l
Malaty	- 5.0 mmol / l
Theoretical osmolarity:	6% solution - 296 mOsm / l
	10% solution - 297 mOsm / l

Description:Bcolorless or yellowish, slightly opalescent liquid.

Pharmacotherapeutic group:Plasmasuberant

ATX: & nbsp

B.05.A.A.07 Hydroxyethyl starch

Pharmacodynamics:

Colloidal plasma-substituting preparation of hemodynamic action, containing 6% (10%) of hydroxyethyl starch (HES) in a balanced solution of electrolytes. The average molecular weight of HES is 130,000 daltons, the degree of molar substitution is 0.4.

6% solution is isoncotic, its volitional effect is 100%.

10% solution is hyperoncotic, so it has a pronounced vollemic effect exceeding 100%.

The duration of the vollemic effect depends mainly on the degree of HES molar substitution and, to a lesser extent, on the average molecular weight of HES. With isovolemic introduction, the effect of volume substitution persists for at least 6 hours.

Hydrolysis products of HES are oncotically active molecules excreted by the kidneys.

It can reduce hematocrit and plasma viscosity.

The composition of the cations in the solution is identical to the physiological concentration of electrolytes in the plasma. Anions are represented by chlorides, acetates and malates, the task of which is to minimize the risk of hyperchloremia and acidosis. The addition of acetates and malates instead of lactates causes a decrease in the risk of lactic acidosis.

Pharmacokinetics:

HES is a substance consisting of molecules with different molecular weights and the degree of molar substitution. Both these values affect the rate of excretion. Small molecules are released in the process of glomerular filtration, and large molecules undergo enzymatic hydrolysis αamylase and is subsequently excreted by the kidneys. The rate of hydrolysis is lower, the higher the degree of substitution.

Approximately 50% of the administered dose of HES is excreted in the urine within 24 hours. After a single administration of 1000 ml of the solution, the plasma clearance is 19 ml / min, and the area under the concentration-time curve is 58 mg-h / ml. The half-life of serum is 12 hours.

Indications:

Treatment of hypovolemia in acute blood loss, if the use of crystalloid solutions is insufficient.

Contraindications:

Hypersensitivity to the components of the drug; sepsis; burns; renal failure or renal replacement therapy; ongoing intracranial or intracerebral bleeding; patients resuscitative profile (usually located in the intensive care unit); hyperhydration; pulmonary edema; dehydration;severe hypernatremia or severe hyperchloremia; severe hepatic impairment; chronic heart failure; severe coagulopathy; patients who underwent organ transplantation.

Carefully:

Ionocles should be used with caution in patients with mild to moderate hepatic impairment; in patients with von Willebrand's disease, hemorrhagic diathesis, hypofibrinogenemia.

At the first signs of coagulopathy the preparation of IONOCHES should be canceled.

Pregnancy and lactation:

At present, there is no reliable clinical data on the use of IONOCHES during pregnancy, therefore it is possible to use it in pregnant women only in cases when the expected benefit of the drug treatment exceeds the possible risk for the fetus (especially in the first trimester).

Since it is not known whether hydroxyethyl starch with breast milk, it should be possible to stop breastfeeding while prescribing the drug to nursing women.

Dosing and Administration:

For intravenous administration.

The dose and speed of administration are set individually and depend on the severity of hemodynamic disorders, the severity of the patient's condition.The use of the drug should be limited to the initial phase of recovery of the circulating blood volume with a maximum time interval of 24 hours.

The first 10-20 ml should be administered slowly and with strict control of the patient's condition, which will make it possible to detect any anaphylactoid reaction as soon as possible.

The lowest effective dose should be used.

Ionohees 6% solution for infusion

The maximum daily dose of the drug is 30 ml / kg (corresponding to 1.8 g / kg of HES). This corresponds to 2250 ml of the drug for a patient with a body weight of 75 kg.

The maximum rate of administration is 20 ml / kg body weight per hour.

Ionoches 10% solution for infusion

The maximum daily dose of the drug is 18 ml / kg (corresponding to 1.8 g / kg of HES). This corresponds to 1350 ml of the preparation for a patient with a body weight of 75 kg.

The maximum rate of administration is 18 ml / kg body weight per hour.

Application in childhood

Due to the limited experience of using HES in children, their use in this group of patients is not recommended.

Side effects:

The most frequent side effects are directly related to the therapeutic effects of HES solutions and dosage, i.e.hemodilution, which is the result of an increase in intravascular space without concomitant administration of blood constituents. Also dilution of coagulation factors, including fibrinogen, may occur. Emerging changes in coagulation factors are subject to correction in accordance with the recommendations but the organization of transfusiologic care in medical and preventive institutions.

Hypersensitivity reactions are very rare and do not depend on the dose.

Effect on the circulatory and lymphatic systems

Decrease in hematocrit and decrease in the content of plasma proteins as a result of hemodilution.

Relatively high dosages of HES lead to dilution of coagulation factors and, thus, to a violation of hemocoagulation. The bleeding time and the APTT index (Activated Partial Thromboplastin Time) may increase, and the activity FVIII/vWF (von Willebrand factor) decrease after administration of the drug in high doses.

Influence on biochemical parameters

As a result of the administration of HES solutions, a short-term increase in the level of α-amylase in the blood serum can occur, which should not be regarded as a violation of the functions of the pancreas.

Anaphylactic reactions

With the introduction of HES, anaphylactic reactions of varying severity can occur up to the development of anaphylactic shock. There are no signs that predict the likelihood or severity of anaphylactic reactions. Therefore, all patients receiving HES solutions should be under constant supervision of medical personnel. In case of the onset of anaphylactic reaction (edema of the face, tongue or throat, difficulty swallowing or breathing, urticaria), the introduction should be immediately discontinued and appropriate non-specific emergency therapy should be prescribed.

The effectiveness of preventive use of corticosteroids has not been proven.

Repeated, for several days, infusions of solutions of HES can lead to skin itch.

Overdose:

Overdose can lead to hypervolemia. In this case, the drug should be discontinued immediately and, if necessary, diuretics introduced.

Interaction:

Hydroxyethyl starch increases the nephrotoxicity of aminoglycoside antibiotics.

Simultaneous use with anticoagulants can increase bleeding time.

When mixed with other drugs in a single container or system, pharmaceutical incompatibility may occur.

Special instructions:

Adequate long-term data on the use of hydroxyethyl starch in patients who underwent surgery or trauma are not available. The expected benefit of treatment should be carefully correlated with uncertain long-term safety. Other available therapeutic measures should be considered.

For the earliest possible detection of anaphylactic reactions, the first 10-20 ml should be administered slowly and under the constant supervision of medical personnel.

Since 10% solution is hyperoncotic, it is necessary to take into account that the volume effect exceeds the volume of the introduced solution (by mobilizing an extravascular fluid); so you need to pay special attention to the risk of hypervolemia.

Always avoid volumetric overload, which can result from overdose, which is especially dangerous for patients with concomitant heart disease, renal insufficiency, and also for elderly patients.

It is necessary to monitor the provision of adequate rehydration of patients. The maintenance of electrolytes in blood serum, liquid balance and kidney function should be monitored. If necessary, electrolytes and liquid must be replenished in accordance with the individual needs of the patient.

It is recommended to monitor the kidney function for 90 days after the infusion of the drug.

It is necessary to monitor the function of the blood clotting system in patients with open heart surgery using artificial circulation, since there are data on increased bleeding in these patients when using other HES preparations.

The drug does not affect the definition of the blood group.

Because of the risk of allergic (anaphylactoid / anaphylactic) reactions, the patient should be under constant observation, and a low initial injection rate should be ensured.

Effect on the ability to drive transp. cf. and fur:

Studies to assess the effect of the drug on the ability to drive vehicles and engage in other potentially hazardous activities,requiring increased concentration of attention and speed of psychomotor reactions, was not conducted.

Form release / dosage:

Solution for infusions, 6% and 10%.

Packaging:

For 250 and 500 ml in polyethylene bottles without a cap or with a welded Euro cap or plastic cap or infusion plug.

For 1 bottle in a hermetically sealed transparent bag of polymer film or without a package in a pack of cardboard box or chrome-ersatz together with instructions for use.

From 1 to 96 bottles without packs in hermetically sealed transparent bags or without packages with an equal number of instructions for use in corrugated box (for hospitals).

Storage conditions:

Store at a temperature of 2 to 25 ° C. Freezing of the drug is not allowed.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-004154

Date of registration:22.02.2017

Expiration Date:22.02.2022

The owner of the registration certificate:EAST-FARM, CJSC EAST-FARM, CJSC Russia

Manufacturer: & nbsp

EAST-FARM, CJSC Russia

Pharmasintez-Tyumen, Open Company Russia

Representation: & nbspEAST-FARM, CJSCEAST-FARM, CJSC

Information update date: & nbsp29.03.2017

Illustrated instructions

Instructions

IONOCHES (Ionokhes)