Volekam GEK-200

General characteristics. Structure:

Active ingredient: 60 g or 100 g of hydroxyethylstarch (GEK 200/0,5).

Excipients: sodium chloride - 9,0 g, waters for injections - to 1 l. Theoretical osmolarity - 308 ¼Äß¼/l.

Pharmacological properties:

Pharmacodynamics. Волекам® GEK-200 - hypertonic colloidal solution on the basis of hydroxyethylated starch (further GEK) - the high-molecular connection consisting of the polymerized dextrose remains. Native starch (amylopectin) which is exposed to splitting for the purpose of receiving molecules with a certain molecular weight, and also to hydroxyethylation at which free hydroxylic groups of the remains of a dextrose are replaced with hydroxyethyl groups on bonds of C2/C6 is a source of receiving GEK. GEK is exposed to long hydrolysis by serumal amylase with education oncotic active oligo-and polysaccharides of various molecular weight.

Волекам® GEK-200, solution for infusions of 6% and 10% - drug of GEK (pentastarch) with an average molecular weight of 200 thousand дальтон and extent of substitution about 0,5.

Due to ability to connect and hold water possesses volemichesky action - ability to increase the volume of the circulating blood (further OTsK) for 85-100% of the entered volume which steadily remains within 4-6 hours.

Has plasma substituting effect, recovers the broken hemodynamics, improves microcirculation, rheological properties of blood (due to decrease in an indicator of a hematocrit), reduces viscosity of plasma, reduces aggregation of thrombocytes and interferes with aggregation of erythrocytes. Similarity of structure of GEK to structure of a glycogen explains the high level of portability and practical lack of side reactions. 

Pharmacokinetics. After intravenous administration it is removed by kidneys (for 24 h - about 70% of the entered pentastarch dose) and with bile.

A small amount collects in reticuloendothelial system ( without having toxic effect on a liver, lungs, a spleen and lymph nodes) where it is split by amylase and further is removed by kidneys and through intestines.

Indications to use:

- Prevention and treatment of a hypovolemia (shock owing to acute blood loss, including intraoperative, injuries, burns, sepsis).
- Disturbance of microcirculation and therapeutic hemodilution, including izovolemichesky.

Route of administration and doses:

Enter intravenously kapelno or struyno. The dose and rate of administering are established individually depending on expressiveness of disturbances of a hemodynamics and weight of a condition of the patient.

In critical situation perhaps bystry introduction of 500 ml of solution (under pressure). At administration of drug under pressure all air has to be previously removed from a bottle (risk of development of an embolism).

The first  10-20  ml  should  be entered  slowly  (possibly development of anaphylactoid reactions).

The daily dose and rate of administering are calculated depending on the size of blood loss, an indicator of hemoglobin and a hematocrit. At patients without risk of emergence of cardiovascular and pulmonary complications duration of therapy is established on hematocrit level (there have to be not lower than 30%).

The maximum speed of infusions depends on initial indicators of a hemodynamics and makes 20 ml/kg/h. Speed at intraoperative introduction, and also at patients with burn and septic shock has to be reduced.

Prevention of a hypovolemia and shock: the maximum daily dose for 6% of solution - 33 ml/kg, 10% of solution - 20 ml/kg. Duration of use is defined by duration and level of a hypovolemia. At the developed shock the average daily dose makes 0,5-1,5 l, the maximum daily dose - 20 ml/kg of 10% of solution (1,5 l on 75 kg) or 33 ml/kg of 6% of solution. At hemorrhagic shock enter with a speed up to 20 ml/kg/h. At septic and burn shock the speed of infusions is slightly less.

The maximum daily dose makes - 33 ml/kg of 6% of solution or 20 ml/kg of 10% of solution.

Acute normovolemichesky hemodilution: for reduction of administration of donor blood at surgeries: 6% enter solution just before operation in the ratio 1:1 at a hematocrit indicator across Tsil after acute normovolemichesky hemodilution not lower than 30. Blood sampling - 2-3 times on 500 ml of own blood, a day dose 2-3 times on 500 ml of solution, blood sampling speed - 1 l in 15-30 min., drug rate of administering - 1 l in 15-30 min. Usually use single administration of drug just before operation. Repeated use is possible if the initial indicator of a hematocrit is in normal limits.

Hemodilution: administration of drug is carried out izovolemichesk (with an intake of own blood) or hypervolemically (without intake of own blood) at small (250 ml), averages (500 ml) and high daily doses (2 times on 500 ml). As criterion of efficiency serves the decrease in an indicator of a hematocrit defined for each patient. Speed of infusions: 250 ml for 0,5-2 h, 500 ml for 4-6 h, 2 times on 500 ml for 8-24 h. Duration of administration of solution - 10 days.

At therapeutic hemodilution the drug Volekam® GEK-200 is used according to multi-day or weeks-long infusional schemes.

Adaptation of the administered drug to hemodynamic and/or haemo rheological indicators is in most cases recommended (the central venous pressure - 15 mm Hg, a hematocrit - 38-42%, etc.).

Features of use:

Due to a possibility of development of allergic reactions introduction of the first 10-20 ml of solution is carried out slowly (kapelno), attentively controlling a condition of the patient.

Treatment should be carried out under control of OTsK, content of electrolytes, leukocytes, thrombocytes, hemoglobin, indicators of a blood coagulation, function of kidneys. At the beginning of therapy it is required to carry out control of content of creatinine in blood serum. At extreme values of content of creatinine (1,2-2 mg/dl or 106-177 µmol/l - the compensated renal failure) it is necessary to weigh carefully need of performing therapy and to exercise dynamic control of liquid balance. It must be kept in mind that Volekam can exert GEK-200 impact on kliniko-chemical indicators (glucose, protein, a blood sedimentation rate, cholesterol, fatty acids, a sorbitdegidrogenaza, specific weight of urine). Introduction of high doses of drug leads to decrease in a hematocrit, concentration of hemoglobin and protein of plasma. Values of hemoglobin are lower than 10 g of % and a hematocrit lower than 27% are considered as critical. Since indicators of crude protein less than 5 g/dl, administration of albumine is shown. At blood loss over 20-25% of OTsK additional introduction of a packed red cells is shown.
At the depressed cases caused by preferential loss of water and electrolytes (vomiting, diarrhea, burns) after initial treatment by drug further treatment should be carried out by means of the balanced solution of electrolytes.

Not to mix drug with other medicines in one capacity and in one system.

During treatment it is necessary to provide sufficient intake of liquid in an organism. At emergence of anaphylactoid reactions administration of drug has to be stopped. The patient needs to be transferred to situation "lying" with the lower extremities raised higher than the level of the head, to release respiratory tracts; to intravenously enter Epinephrinum. Previously having diluted 1 ml of solution (1:1 thousand) to 10 ml of Yosnachal it is necessary to enter slowly 1 ml of the received solution (0,1 mg), controlling at the same time pulse and arterial pressure. Introduction of Epinephrinum can be repeated. Then intravenously appoint 5% solution of human albumine (for completion of OTsK), glucocorticosteroid drugs (250-1000 mg of Prednisolonum), antihistaminic medicines. Patients have to be under continuous medical observation, additional therapeutic measures have to be taken depending on a condition of patients.

At treatment of patients whose blood group is not established it must be kept in mind that introduction of large volumes of Volekama® of GEK-200 can complicate interpretation of results of an agglutination test at blood typing.

After administration of drug activity of amylase considerably increases in blood which  is returned  to  norm  in  3-5  days  (can complicate laboratory diagnosis of pancreatitis, without influencing a clinical picture).

Side effects:

Allergic reactions: urticaria, a skin itch, it is rare - anaphylactoid reactions, nausea, vomiting, hypotonia, tachycardia, fervescence, a headache (it is necessary to stop administration of drug). Disturbances of a hemodynamics (at bystry introduction or use of high doses), a persistent reversible skin itch. Increase in activity of serumal amylase (it is not connected with clinical displays of pancreatitis).

Interaction with other medicines:

In need of mixing with other medicines      the full   asepsis has to be observed;   it is necessary   to be convinced of compatibility and good mixing of medicines. Pharmaceutical it is incompatible with solutions of other medicines.

Contraindications:

Hypersensitivity (including to starch), intracranial hypertensia, intracranial bleeding, dekompensirovanny chronic heart failure, an acute renal failure (oligo-, an anury), a cardiogenic fluid lungs, an overhydratation, a hypervolemia, dehydration (in need of correction of electrolytic exchange), the expressed disturbances of coagulant system of blood (including heavy hemorrhagic diathesis, hypocoagulation), a hyperchloremia, a hypernatremia, a hypopotassemia, children's age.

With care. Pregnancy, lactation period; the compensated chronic heart failure and a chronic renal failure, chronic diseases  of a liver,    an angiohemophilia,  hemorrhagic diathesis, a hypofibrinogenemia.

Overdose:

At bystry introduction in large volumes it is possible to provoke development of an acute left ventricular failure and fluid lungs.

In case of complaints to feeling of constraint in a breast, difficulty of breath, a back pain, and also at emergence of a fever, cyanosis, disturbance of blood circulation and breath it is necessary to stop administration of drug and to carry out the corresponding symptomatic therapy.

Storage conditions:

In the place protected from light, at a temperature not above 25 °C. Freezing of drug is not allowed. To store in the place, unavailable to children. Period of validity 3 years. Not to use after the expiry date specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Solution for infusions of 6%, 10%. On 200 ml or 400 ml place in bottles glass for blood, infusional and transfusion drugs with a capacity of 250 ml or 450 ml, respectively, corked by traffic jams from rubber mix and pressed out by aluminum caps. On 28 bottles on 200 ml, on 15 bottles on 400 ml together with 5-10 application instructions place in boxes from corrugated fibreboard (for hospitals).