Infukol HES

Active material: Pentastarch (Gidroksietilkraxmal)
When ATH: B05AA07
CCF: Plasma-drug
ICD-10 codes (testimony): E86, I63, I73.0, I73.1, I73.9, I79.2, J44, O43, P 61.2, R57.1, R57.8, T79.4, Z31.1
When CSF: 21.05
Manufacturer: Serumwerk Bernburg AG (Germany)

Pharmaceutical form, composition and packaging

Solution for infusion 6% in the form of colorless or yellowish, a transparent or slightly opalescent liquid.

Excipients: isotonic solution (On⁺ 154 mmol / l, Cl^– 154 mmol / l), water d / and.

100 ml – bottles (1).
100 ml – bottles (10).
250 ml – bottles (1).
250 ml – bottles (10).
250 ml – bags plastic “Propifleks” (Propyflex®) (1).
250 ml – bags plastic “Propifleks” (Propyflex®) (10).
500 ml – bottles (1).
500 ml – bottles (10).
500 ml – bags plastic “Propifleks” (Propyflex®) (1).
500 ml – bags plastic “Propifleks” (Propyflex®) (10).

Solution for infusion 10% in the form of colorless or yellowish, a transparent or slightly opalescent liquid.

Excipients: isotonic solution (On⁺ 154 mmol / l, Cl^– 154 mmol / l), water d / and.

100 ml – bottles (1).
100 ml – bottles (10).
250 ml – bottles (1).
250 ml – bottles (10).
250 ml – bags plastic “Propifleks” (Propyflex®) (1).
250 ml – bags plastic “Propifleks” (Propyflex®) (10).
500 ml – bottles (1).
500 ml – bottles (10).
500 ml – bags plastic “Propifleks” (Propyflex®) (1).
500 ml – bags plastic “Propifleks” (Propyflex®) (10).

Pharmacological action

HES infusion solution Infukol – this is accordingly 6% and 10% a solution of a synthetic colloid of hydroxyethyl starch obtained from potato starch in an isotonic solution with an average molecular weight 200 000 dalton and degree of substitution 0.45-0.55. Due to the ability to bind and retain water (incl. from the interstitial space to the intravascular space), the drug has a volemic effect within 85-100% and 130-140% administered volume, respectively, for 6% and 10% solution, which stably maintained for a 4-6 no. Physico-chemical parameters of the original drug substance Infukol HES provide a high therapeutic efficacy in hypovolemia and shock, and also when used for therapeutic hemodilution due to the normalization of central and peripheral hemodynamics, microcirculation, improve delivery and oxygen consumption of organs and tissues, Recovery apart capillary walls (normalizing vascular permeability), reducing the local inflammatory response, activation of a full immune response, mobilization of blood cells from the saline deposits and their involvement in active metabolism during moderate hemodilution.

Besides, the drug improves the rheological properties of blood by reducing hematocrit values, and also reduces plasma viscosity, reduces platelet aggregation and prevents erythrocyte aggregation.

The drug does not exhibit local irritation and immunotoxic effects. Depositing in the cells of the reticuloendothelial system, the drug has no toxic effect on the liver, lungs, spleen and lymph nodes.

The similarity of the structure of the drug Infukol HES structure glycogen explains the high level of tolerability and the almost complete absence of side reactions.

Under the influence of serum amylase, the drug Infucol HES is broken down into low molecular weight fragments (less 70 000 Dalton), that the kidneys.

Pharmacokinetics

At the moment 12 h after administration of the drug T_1/2 is 4.94 no. The clearance indicator is 7.33 ml / min. C_max in serum is 11.1 ± 2.7 mg / ml; on the third day after the administration of the serum are determined by trace amounts of the drug. For the first 12 h after start of administration of the drug present in the urine 24.48 ± 3.93 mg / ml HES Infukol (49% of the amount administered).

Testimony

- prevention and therapy of hypovolemia and shock during operation, acute blood loss, injuries, infectious diseases and burns;

- Violations of the microcirculation;

- therapeutic blood dilution (hemodilution), incl. in the treatment of twin-placental insufficiency and gestosis, antiphospholipid syndrome in women, in vitro fertilization programs, polycythemia in newborns, in the treatment of obliterating lesions of the vessels of the lower extremities, chronic obstructive pulmonary diseases, ischemic strokes (acute and subacute stages, acute ischemic stroke with reduced cardiac output and microangiopathies, in the presence of signs of dehydration and hypovolemia, if there are signs of hemoconcentration/hematocrit number more than 35%/).

Dosage regimen

Infucol HES is prescribed as an intravenous infusion.

Doses of the drug Infucol HES (6% solution) are presented in Table.

Doses of the drug Infucol HES (10% solution) are presented in Table.

In the absence of other prescriptions, the drug Infucol HES is administered intravenously by drip in accordance with the need to replace the volume of circulating fluid and the required level of hemodilution.

Babies and children under the age of 3 years It is recommended to prescribe an average daily dose of the drug. Due to the peculiarities of water and electrolyte status in children, careful monitoring of hydration levels and electrolyte levels is recommended..

Considering possible anaphylactic reactions, first 10-20 ml of Infucol HES should be administered slowly, with careful monitoring of the patient's condition.

The daily dose and rate of intravenous administration are calculated depending on blood loss, hemoglobin concentration and hematocrit. In young patients without the risk of damage to the cardiovascular system and lungs, the limit for the use of a colloidal volume replacement drug is considered to be hematocrit, equal 30% less.

The maximum rate of infusion depends on baseline hemodynamics and is approximately 20 mL/kg body weight/h.

The maximum daily dose is up to 33 ml 20 ml of the product (to 6% and 10% solution, respectively,) on 1 kg body weight / day (2 g hydroxyethyl starch/1 kg/day).

Standard option for therapeutic hemodilution for ischemic stroke

1. “Loading dose” depending on hematocrit:

and) with a hematocrit number less than 40% (hypervolemic therapeutic hemodilution): 500 ml 6% Infucol HES solution and 500 ml of electrolyte solution for 1 no;

to) with a hematocrit number of more than 40% (isovolemic therapeutic hemodilution): take 500 ml of blood with simultaneous administration 500 ml 6% Infucol HES solution and 500 ml of electrolyte solution for 1 no.

2. Therapeutic hemodilution in 1-4 day:

and) with a hematocrit number less than 40% (hypervolemic therapeutic hemodilution): 1000 ml 6% Infucol HES solution and 1000 ml of electrolyte solution for 24 no;

to) with a hematocrit number of more than 40% (isovolemic therapeutic hemodilution): take 500 ml of blood with simultaneous administration 500 ml 6% Infucol HES solution and 500 ml of electrolyte solution for 24 no.

3. Therapeutic hemodilution for 5-10 day:

hypervolemic therapeutic hemodilution: 500 ml 6% Infucol HES solution and 500 ml of electrolyte solution for 12 no.

4. Use of cardiac glycosides according to a standard regimen in accordance with clinical indications.

5. Inhibition of platelet aggregation:

and) 1-4 day: single injection of acetylsalicylic acid 500 mg / day (when excluding intracranial bleeding);

to) 5-10 day: single injection of acetylsalicylic acid 500 mg/day and ascorbic acid (vitamin C) inwards 400 mg / day.

6. Use of hemorheologically active drugs (means, improve cerebral circulation) and means, improving brain metabolism:

- nootropics for clinical indications;

- pentoxifylline in medium doses (in / on 200-300 mg 2 times / day).

Therapeutic hemodilution should be started as early as possible (upon first contact with the patient).

An acute significant increase in intracranial pressure is a contraindication to further therapeutic hemodilution.

Minor intracranial bleeding is not a contraindication to further therapeutic hemodilution.

Introduction 6% Infucol HES solution should be carried out continuously, incl. and at night.

Injected volume 6% Infucol HES solution should be correlated with myocardial contractility (control heart rate).

Appropriate volume can be used 10% Infucol HES solution with corrective administration of electrolyte solution (Sodium overload must be avoided).

When performing isovolemic hemodilution, the occurrence of hypovolemia is unacceptable.: blood collection should occur simultaneously with administration 6% Infucol HES solution, the rate of blood collection should never exceed the rate of administration of Infucol HES solution.

It is advisable to achieve an initial reduction in hematocrit number by 12-15%.

If there is a threat of cerebral edema,: elevated body position (30°); head position, facilitating venous outflow; rapid administration of hyperosmotic drugs (glycerol, sorbitol).

Administration of cortisone and diuretics is not indicated.

Side effect

Allergic reactions: rarely – hard, but reversible itching; rarely – anaphylactoid reactions.

Contraindications

- Gipergidratatsiya;

- Gipervolemia;

- Heart failure decompensation;

- renal failure with decompensated oliguria or anuria;

- cardiogenic pulmonary edema;

- intracranial bleeding;

- severe bleeding disorders;

- hypersensitivity to starch and other components of the drug.

Contraindications to the use of therapeutic hemodilution in acute cerebrovascular accidents:

- severe hemorrhagic diathesis;

- myocardial infarction during the last 6 weeks;

— angina pectoris IV functional class, all types of unstable angina;

- circulatory failure stage IIB-III;

- Chronic renal failure (creatinine level is more 2 mg / dL);

- significant increase in intracranial pressure;

- history of seizures;

- profuse bleeding;

- initial hematocrit values ​​are less than 35%;

- arterial hypertension poorly corrected by antihypertensive therapy (systolic blood pressure more than 180 mmHg. and diastolic – more 120 mmHg.)

Pregnancy and lactation

Infucol HES is used with caution in the first trimester of pregnancy.

In case of feto-placental insufficiency and gestosis in pregnant women with high blood pressure, treatment should be carried out against the background of antihypertensive therapy.

Established, that the drug has no embryotoxicity or teratogenicity.

Cautions

Precautions prescribers with hemorrhagic diathesis, intracranial hypertension, in states of dehydration (preliminary corrective therapy is required) and pronounced disturbances of water and electrolyte balance.

It should be taken into account, that the intravenous administration of the drug is too fast, as well as use in high doses, may lead to hemodynamic disturbances.

During treatment, it is necessary to monitor the serum ionogram and fluid balance, renal function.

If intolerance reactions occur, you should immediately stop administering the drug and take the necessary emergency measures..

It should be taken into account, that when using the drug, an increase in serum amylase activity is possible, that is not associated with clinical symptoms of pancreatitis. The drug Infucol HES can be used in the conservative and surgical treatment of patients with destructive pancreatitis.

Administration of the drug to patients with diabetes is not accompanied by an increase in blood glucose levels, therefore, the drug Infucol HES can be used in the conservative and surgical treatment of this category of patients.

Established, that the drug does not have a mutagenic effect.

Overdose

Currently, no cases of overdose of the drug Infucol HES have been reported..

Drug Interactions

Pharmaceutical interaction

When mixed with other medicinal products in the same container and in the same system, incompatibility may occur..

Conditions of supply of pharmacies

The drug Infucol HES is available by prescription.

Conditions and terms

The drug should be stored out of reach of children at or above 25 ° C.

Infucol HES should only be used, if the solution is clear, but the packaging is not damaged.

Shelf life – 5 years for the drug in glass vials; 3 year for the drug in polymer bags.