Composition, form of production and packaging
Solution for infusion 1000 ml
Hydroxyethylated starch [m. 130 thousand Da, mol substitution 0.42] 100 g
potassium chloride 300 mg
calcium chloride dihydrate 370 mg
magnesium chloride hexahydrate 200 mg
sodium acetate trihydrate 327 mg
sodium chloride 6.25 g
malic acid 670 mg
1000 ml - plastic containers (10) - cardboard boxes.
250 ml - plastic containers (20) - cardboard boxes.
500 ml - polyethylene bottles (10) - cardboard boxes.
500 ml - plastic containers (20) - cardboard boxes.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2010.
PHARMACHOLOGIC EFFECT
Tetraspan 10 is a colloidal plasma-substituting solution containing 10% 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 0.42.
Tetraspan 10 is a hyperoncotic solution, so it has a pronounced volitional 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.
Tetraspan 10 can reduce hematocrit and plasma viscosity. The composition of the cations in Tetraspan 10 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 excreted in the process of glomerular filtration, and large molecules are subjected to enzymatic hydrolysis of α-amylase and are 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 injection of 1000 ml of Tetraspan 10, plasma clearance is 19 ml / min, and the area under the concentration-time curve is 58 mg / hr. T 1/2 of serum corresponds to 12 hours.
INDICATIONS
- prevention and treatment of relative and absolute hypovolemia, shock, developing due to bleeding or trauma, intra-operative blood loss, burns, sepsis;
- acute normovolemic hemodilution, therapeutic hemodilution;
filling the apparatus of extracorporeal circulation.
DOSING MODE
For intravenous administration.
The daily dose and rate of administration depend on the magnitude of hemorrhage and hemodynamic parameters.
The maximum daily dose:
For adults: up to 30 ml / kg of body weight of Tetraspan 10 (corresponding to 3.0 g / kg of HES body weight). This corresponds to 2000 ml of Tetraspan 10 for a patient with a body weight of 70 kg.
Maximum injection rate:
The maximum rate of administration depends on the clinical situation. Patients in the acute phase of shock can be administered up to 20 ml / kg body weight per hour (corresponding to 0.33 ml / kg body weight per minute or 2.0 g / kg body weight HES per hour).
In life-threatening conditions, a rapid injection of 500 ml of solution (under pressure) is possible.
Duration of therapy:
The duration of therapy depends on the duration and severity of hypovolemia, hemodynamic effect as a result of the therapy and the level of hemodilution.
SIDE EFFECT
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. Dilution of coagulation factors can also occur. Hypersensitivity reactions are very rare and do not depend on the dose.
Influence 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 of FVIII / vWF (vWF) decreases 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 О±-amylase in the 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. Therefore, all patients receiving HES solutions should be under the constant supervision of medical personnel for the occurrence of anaphylactic reactions. In case of occurrence of anaphylactic reactions, the administration should be stopped immediately and emergency therapy is prescribed.
CONTRAINDICATIONS
hyperhydration, including pulmonary edema;
- severe renal failure with oliguria or anuria;
- intracranial bleeding;
marked hyperkalemia;
severe hypernatremia or severe hyperchloremia;
Decompensated severe hepatic insufficiency;
congestive heart failure;
hypersensitivity to one or more of the components of the drug.
With caution: Tetraspan 10 should be used for bleeding disorders, especially if von Willebrand disease is identified or suspected.
PREGNANCY AND LACTATION
At present, there is no reliable clinical data on the use of Tetraspan 10 during pregnancy, therefore it is possible to use it in pregnant women only in cases where the expected benefit from the drug treatment exceeds the possible risk to the fetus (especially in the first trimester).
Since it is not known whether Tetraspan 10 is excreted in breast milk, it should be possible to stop breastfeeding while prescribing the drug to lactating women. Special studies of the efficacy and safety of Tetraspan 10 in pediatric practice have not been conducted.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated in severe renal failure with oliguria or anuria.
Always avoid volumetric overload, which can result from overdose, which is especially dangerous for patients with renal insufficiency.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated in decompensated severe hepatic insufficiency.
APPLICATION IN ELDERLY PATIENTS
Always avoid volumetric overload, which can result from overdose, which is especially dangerous for elderly patients.
SPECIAL INSTRUCTIONS
Since Tetraspan 10 is a hyperoncotic solution, it is necessary to take into account that the volume effect exceeds the volume of the injected 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.
The maintenance of electrolytes in blood serum, liquid balance and kidney function should be monitored.
In the case of severe dehydration, the water-electrolyte balance should be normalized initially by introducing balanced electrolyte solutions.
In order to compensate for the lack of extravascular fluid resulting from the movement of fluid from the interstitial to the intravascular space, adequate fluid delivery should be provided.
To correctly determine the group membership of the patient's blood, a blood sample must be taken before the administration of Tetraspan 10. For the earliest possible detection of the threat of anaphylactic reactions, the first 10-20 ml should be administered slowly and under the constant supervision of medical personnel.
OVERDOSE
An overdose of Tetraspan 10 can lead to hypervolemia. In this case, the drug should be discontinued immediately and, if necessary, diuretics introduced.
DRUG INTERACTION
To date, no interactions between Tetraspan 10 and other drugs or nutritional supplements have been identified.
TERMS OF RELEASE FROM PHARMACY
For use in hospitals.
TERMS AND CONDITIONS OF STORAGE
Store at a temperature not higher than 25 В° C in places inaccessible to children. Do not freeze! Shelf life - 2 years.
