Composition, form of production and packaging
Solution for infusions 10% transparent, slightly opalescent, from colorless to light yellow color.
hydroxyethyl starch 200 / 0.5 100 g
theoretical osmolarity ~ 300 mOsmol / l colloid osmotic pressure ~ 85 mbar (65 mmHg) pH 4.0 - 7.0
[PRING] sodium chloride - 9 g, water d / and - 931 g.
250 ml - glass bottles (10) - cardboard boxes.
500 ml - glass bottles (10) - cardboard boxes.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2008.
Plasmo-replacing drug. It is a 10% isotonic solution of hydroxyethylated starch (HES) (hydroxyl derivative of the product of acidic hydrolysis of corn starch) with an average molecular weight of 200,000 daltons and a degree of substitution of 0.5, which means that there are 5 hydroxyethyl groups per 10 glucose residues of amylopectin.
HES due to the ability to bind and retain water has the ability to increase BCC by 85-100% of the injected volume (the plasma-substituting effect persists for 4-6 hours). It restores disturbed hemodynamics, improves microcirculation, rheological properties of blood (by reducing the hematocrit), reduces blood viscosity, reduces platelet aggregation and prevents aggregation of erythrocytes.
The similarity of the structure of hydroxyethyl starch with the structure of glycogen explains the good tolerability of the drug, it does not have a locally irritating and immunotoxic effect. Accumulating in the cells of RES, does not have toxic effects on the liver, lungs, spleen, lymph nodes.
- Replenishment of blood volume in vessels under conditions of insufficient volume of circulating blood;
- prevention and therapy of hypovolemic shock in connection with burns, injuries, operations;
- hemodilution (for example, isovolemic hemodilution).
Mode of application
Continuous intravenous infusion with the help of a dropper.
The first 10-20 ml should be administered slowly and with strict monitoring of the patient's condition, because the complete exclusion of anaphylactoid reactions is not possible. The daily dose and rate of infusion depend on the size of the blood loss of the hematocrit value. The duration and extent of therapy depend on the duration and extent of hypovolemia. When using the drug for hemodilution purposes, they usually work according to the schemes of multi-day therapy.
When replacing the blood volume, the average daily dose is, as a rule, 250-1000 ml. Only in exceptional cases is it possible to exceed the value of 20 ml / kg of body weight / day. When using the drug for hemodilution for a few days in a row, the daily dose is usually 250-500 ml. A total dosage of 5 liters can be exceeded only in exceptional cases, and the dose can be distributed for a treatment period of up to 4 weeks.
In the absence of an acute emergency, the recommended duration of infusion is at least 30 minutes per 500 ml of Refortan HES 200 / 0.5.
Use only transparent to slightly opalescent and colorless to stained no more intensively than in slightly yellow solutions.
Only for one-time use.
Use only solutions in intact containers!
Use of solutions after the expiry date is not permitted!
Refortan HES 200 / 0.5 from the starting capacity should be consumed as soon as possible.
Anaphylactoid reactions to hydroxyethyl starch (incidence - in terms of the number of units of infusion solution introduced - about 0.085%). Such reactions are manifested in the form of vomiting, a slight increase in temperature, chills, itching and nettle fever. There was an increase in the upper submandibular and parotid salivary glands, flu symptoms (headache, muscle pain and peripheral edema of the lower limbs).
Intolerance reactions accompanied by shock and life-threatening symptoms (sometimes up to the cessation of the blood circulation of the heart and respiratory arrest) are extremely rare (the incidence - in terms of the number of units of the infusion solution - about 0.006%).
If an intolerance reaction occurs, the infusion should be stopped immediately, and all necessary emergency measures should be taken at the same time (see Special instructions).
Both during and after the end of high-dose prolonged therapy for hemodilution with the use of infusion solutions of HES, there was a transient occurrence of itching.
The level of amylase in the serum after the infusion of the drug Refortan HES 200 / 0.5 noticeably increases, however, after 3-5 days again comes back to normal.Diagnostic or therapeutic measures are not required.
With the introduction of high doses of the drug Refortan HES 200 / 0.5, the possibility of the onset of increased bleeding (liquefaction effect, and sometimes even a specific effect of the drug) is not ruled out. Therefore, it is necessary to increase the dosage to a value exceeding the recommended maximum only in exceptional cases.
- states of hyperhydration;
severe congestive heart failure;
renal failure in combination with oliguria or anuria, as well as serum creatinine 2.0 mg / dl;
- severe hemorrhagic diathesis;
- known hypersensitivity of the patient to hydroxyethyl starch (HES).
Particular caution is recommended for patients with pulmonary edema, decompensated heart failure, impaired renal function, chronic liver disease, hemorrhagic diathesis or dehydration with narrowing of the extracellular space, in which case it is recommended to first replace the liquid (using crystalloid solutions). Given the results of the studies, it is also recommended that care should be taken with a lack of fibrinogen. Data on the use in children under the age of 10 years of data is not available.
PREGNANCY AND LACTATION
There is also no experience of using the drug during pregnancy and lactation, therefore it is recommended to carefully weigh the benefit-risk ratio when using Refortan HEK 200 / 0.5.
APPLICATION FOR FUNCTIONS OF THE LIVER
Particular caution is recommended for patients with impaired renal function.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Particular caution is recommended for patients with chronic liver disease.
APPLICATION FOR CHILDREN
Data on the use in children under the age of 10 years of data is not available.
The first 10-20 ml should be administered slowly, carefully monitoring the patient's condition, because the complete exclusion of anaphylactoid reactions is not possible.
Emergency measures to help with the occurrence of reactions of intolerance:
Skin reactions Antihistamines
Tachycardia, falling AD, nausea, vomiting. Antihistamines and GCS, for example 100 mg of prednisolone IV
III. Shock, bronchospasm 1. Adrenaline 0.05 - 0.1 mg slowly in / in. 2. SCS, for example 1000 mg of prednisolone IV. 3. Substitution of volume, for example. 5% of people. albumin. 4. Oxygen and the implementation of resuscitation measures taken in such cases.
IV. Heart and / or respiratory arrest
It is necessary to take into account the risk of overloading the circulation at too high a dose and too high infusion rate.
During treatment with Refortan HES 200 / 0.5 it is necessary to monitor the sufficient supply of the body with liquid. It is recommended to monitor serum electrolytes (in terms of sodium, potassium and chloride).
In the case of shock conditions caused mainly by loss of water and electrolytes (severe vomiting, diarrhea, burns), after initial treatment with the use of the drug Refortan HES 200 / 0.5, further treatment with a balanced solution of electrolytes is recommended.
Increased doses of the drug Refortan HES 200 / 0.5 cause the effect of dilution and lead to a decrease in hematocrit, as well as a decrease in the concentration of hemoglobin and plasma protein. Values вЂ‹вЂ‹of hemoglobin below 10 g% and hematocrit below 27 are considered critical. Starting with the total protein values вЂ‹вЂ‹<5.0 g%, the introduction of albumin is indicated. With blood loss of more than 20-25% of the circulating blood volume, additional introduction of red blood cells is necessarily indicated.
With simultaneous use with aminoglycoside antibiotics, HES is able to potentiate their nephrotoxicity.
HES can affect clinical and chemical indices (glucose, protein, ROE, biuret, fatty acid, cholesterol, sorbitol dehydrogenase, specific gravity of urine, urine electrophoresis in the form of pseudo-paraproteinuria).
When combining infusion solutions (concentrates for the preparation of infusion solutions, injectable solutions and powders for injection purposes or dry matter for the preparation of injection solutions), it is recommended that each time carefully (at least visually) check the compatibility (miscibility) of the preparations (nevertheless, nevertheless invisible to the eye chemical or therapeutic incompatibilities).
TERMS AND CONDITIONS OF STORAGE
Keep the medicine out of the reach of children!
Store at a temperature of no higher than 25 В° C! Shelf life - 5 years.
Use until the date shown on the package.