Tetraspan 6 (Tetraspan 6)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspsolution for infusions
Composition:

1000 ml of the solution contain:

Active substances:

Dhydroxyethyl starchTO)

(Poly (O-2-hydroxyethyl) -starch)

(average molecular weight 130,000 daltons,

the degree of molar substitution is 0.42)

60,000 g

Sodium chloride

6,250 g

Potassium chloride

0.300 grams

Calcium chloride dihydrate

0.370 g

Magnesium chloride hexahydrate

0.200 g

Sodium acetate trihydrate

3.270 g

Apple acid (L-Apple acid)

0.670 g

Excipients:

A solution of sodium hydroxide 40%

1.197 g

Water for injections

up to 1000 ml

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

Physico-chemical characteristics:

Theoretical osmolality

296 mOsm / l

pH

from 5.6 to 6.4
Description:

Colorless or yellowish, slightly opalescent liquid.

Pharmacotherapeutic group:plasma-substituting agent
ATX: & nbsp
  • Hydroxyethyl starch
    • Pharmacodynamics:

    Tetraspan 6 is a colloidal plasma-substituting solution containing 6% 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 6 is an isononic solution with a volatile effect of 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.

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

    Tetraspan 6 can reduce hematocrit and plasma viscosity.

    With isovolemic introduction, the volume-replacing effect is maintained for at least 6 hours.

    The composition of the cations in Tetraspan 6 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 manat instead of lactates is due to 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 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 Tetraspan 6, the plasma clearance is 19 ml / min, and the area under the concentration-time curve is 58 mg / 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:

    - Xheart failure in decompensation;

    - intracranial hemorrhage, acute disturbance of cerebral circulation by hemorrhagic type;

    - severe hyperkalemia;

    - severe hypernatremia or severe hyperchloremia;

    - decompensated severe hepatic impairment;

    - severe bleeding disorders;

    - dehydration;

    - condition after organ transplantation.

    Carefully:

    Caution should be applied Tetraspan 6:

    - in patients with compensated heart failure;

    - in patients with intracranial hypertension;

    - with violations of blood coagulability, hemorrhagic diathesis, especially with the identified or suspected Willebrand disease.Cancel at the first sign of coagulopathy.

    Pregnancy and lactation:

    At present, there are no reliable clinical data on the use of Tetraspan 6 during pregnancy, so 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 HES in Tetraspan 6 is excreted in breast milk, it should be possible to stop breastfeeding while prescribing the drug to lactating women.

    Dosing and Administration:

    For intravenous administration.

    The daily dose and rate of administration depend on the magnitude of hemorrhage and hemodynamic parameters.

    The maximum daily intake for adults

    Up to 50 ml / kg of body weight of Tetraspan 6 (corresponding to 3.0 g / kg body weight HES). This corresponds to 3,500 ml of Tetraspan 6 for a patient weighing 70 kg.

    In the case of Tetraspan 6 in children, dosages should be individualized in accordance with hemodynamic status and concomitant diseases: in children aged 10-18 years the maximum daily dose is 33 ml / kg of body weight; in children 2-10 years the maximum daily dose is 25 ml / kg of body weight; in newborns and children under 2 years the maximum daily dose is 25 ml / kg of body weight.

    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 1.2 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 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 on the organization of transfusiological 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 introduction of HES solutions, a short-term increase in the level α-amylases in the blood serum, 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.If an anaphylactic reaction develops (swelling 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:

    An overdose of Tetraspan 6 can lead to hypervolemia. In this case, the drug should be discontinued immediately and, if necessary, diuretics introduced.

    Interaction:To date, no interactions between Tetraspan 6 and other drugs or nutritional supplements have been identified.
    Special instructions:

    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.

    Always avoid volumetric overload, which can result from overdose, which is especially dangerous for patients with concomitant cardiac pathology, as well as 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.

    Tetraspan 6 does not affect the determination 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.

    Form release / dosage:

    Solution for infusion.

    Packaging:

    500 ml bottles of low-density polyethylene with Euro-cap, meeting the requirements of the European Pharmacopoeia for infusion solutions.

    250 ml, 500 ml and 1000 ml in plastic containers of multilayer film of the brand Cryovac M 312 or 312 A, meeting the requirements of the European Pharmacopoeia for infusion solutions. The container is placed in a secondary transparent plastic bag.

    10 bottles of 500 ml, 20 containers of 250 ml or 500 ml, 10 ml container 1000 along with instructions for use in an appropriate amount in a carton (for hospitals).

    Storage conditions:Store at a temperature of no higher than 25 ° C? in places inaccessible to children.
    Do not freeze.
    Shelf life:

    3 years in bottles of polyethylene,

    2 years in plastic containers.

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

    Terms of leave from pharmacies:For hospitals
    Registration number:LSR-006272/08
    Date of registration:06.08.2008
    The owner of the registration certificate:B. Brown Mehlungen AGB. Brown Mehlungen AG Germany
    Manufacturer: & nbsp
    Representation: & nbspB. Brown Medikal, Open CompanyB. Brown Medikal, Open Company
    Information update date: & nbsp22.02.2016
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