Venofundin - instructions for use, dose, side effects, contraindications

1000 ml of the solution contain
Active substance: Hydroxyethyl starch (HES) (Poly (0-2-hydroxyethyl) -starch), the average molecular weight is 130,000 Daltons, the degree of molar substitution is 0.42)	60 grams
Excipients:
Sodium chloride	9.00 g
Water for injections	up to 1000 ml
Concentration of electrolytes:
Sodium	154.0 mmol / l
Chlorides	154.0 mmol / l
Physico-chemical characteristics:
Theoretical osmolality	309 mOsm / l
pH	from 4.0 to 6.5

Description:Colorless or pale yellow, slightly opalescent solution.

Pharmacotherapeutic group:Plasmasuberant

ATX: & nbsp

B.05.A.A.07 Hydroxyethyl starch

Pharmacodynamics:Hydroxyethyl starch (HES) are derived from amylopectin and are characterized by their molecular weight and degree of substitution. For the preparation Venofundin, the average molecular weight of HES is 130,000 Daltons, and the degree of substitution is 0.42. HES is structurally related to glycogen, which explains its high tolerance and low risk of anaphylactic reactions.

Venofundin is an isonicotic solution, i.e. intravascular volume of plasma with its infusion increases equivalent to the volume introduced.

The duration of the vollemic effect depends more on the degree of molar substitution and, to a lesser extent, on the molecular weight.

Hydrolysis of HES in the intravascular space leads to the formation of molecules with a lower molecular weight, which are also oncotically active until they are excreted by the kidneys.

Venofundin can reduce hematocrit and plasma viscosity.

The volemic effect resulting from isovolemic administration (the preparation of venofundin lasts at least 6 hours.

Pharmacokinetics:HES is a mixture of molecules with different degrees of molar substitution and different molecular weight, both of these values affect the rate of excretion. Small molecules are excreted by glomerular filtration, large molecules are subjected to enzymatic hydrolysis by a-amylase and subsequently excreted by the kidneys. The rate of hydrolysis is lower, the higher the degree of substitution. About 50% of the administered dose is excreted in the urine within 24 hours.

After a single administration of 1000 ml of Venofundin preparation, plasma clearance is 19 ml / min, AUC 58 mg ∙ h / ml, the area under the concentration-time curve is -58 mg ∙ h / 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:

Hypersensitivity to hydroxyethyl starch or other components of the drug;
Sepsis;
Renal failure with oliguria or anuria, not associated with hypovolemia;
Hemodialysis;
Hyperhydration, including pulmonary edema;
Hypervolaemia;
Chronic heart failure in the stage of decompensation;
Intracranial hemorrhage, acute disturbance of cerebral circulation by hemorrhagic type;
Severe hypernatremia or severe hyperchloremia;
Decompensated severe hepatic impairment;
Severe bleeding disorders;
Dehydration;
Condition after organ transplantation;
The first trimester of pregnancy.

Carefully:

With caution should be used Venofundin:

- In patients with hepatic insufficiency;

- In patients with compensated heart failure;

- In patients with intracranial hypertension;

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

- In the second and third trimester of pregnancy;

- Patients in critical condition, usually in the intensive care unit, intensive care unit.

Pregnancy and lactation:

At present, there is no sufficient clinical data on the use of Venofundin during pregnancy. The use of the drug Venofundin in the first trimester of pregnancy is contraindicated. Perhaps its use in pregnant women in the second and third trimesters of pregnancy only in cases where the expected benefit of treatment with the drug exceeds the possible risk of complications.

Since it is not known whether the HES contained in the preparation of Venofundin with breast milk is deduced, it is necessary to provide for the possibility of stopping 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 blood loss and hemodynamic parameters.

The highest daily dose

The highest daily dose of venofundin for adults should not exceed 50 ml / kg of body weight, which corresponds to 3 g of HES / kg of body weight (about 3500 ml for a patient with a body weight of 70 kg).

In the case of the use of the drug Venofundin in children, the dosage should be individualized in accordance with the hemodynamic status and the concomitant diseases;

in children aged 10-18 years, the highest daily dose is 33 ml / kg of body weight; in children 2-10 years the highest daily dose is 25 ml / kg of body weight; in newborns and children up to 2 years the highest daily dose is 25 ml / kg of body weight

Maximum injection rate

The maximum rate of administration depends on the clinical situation. In the acute stage of shock, a rate of administration of up to 20 ml / kg body weight / hour is recommended, which corresponds to 0.33 ml / kg body weight / min (1.2 g HES / kg body weight / hour). In a critical situation, a quick injection of 500 ml of solution (under pressure) is possible. When the preparation is administered under pressure, if Venofundin is used in plastic containers, all air from the containers and the administration system must be removed beforehand to avoid the risk of embolism.

The duration of therapy depends on the duration and severity of hypovolemia and the hemodynamic effect of the therapy and the level of hemodilution.

Side effects:

The following classification of incidence of side effects is used: Very frequent (≥1 / 10), frequent (≥1 / 100, <1/10), infrequent (≥1 / 1000, <1/100); Rare (≥1 / 10000, <1/1000); very rare (<1/10000).

The most common side effects are directly related to the main effects of HES solutions and the dose of the drug. Possible reduction in coagulation factors, due to hemodilution as a result of the introduction of solutions of HES without the parallel introduction of blood components.

Allergic reactions occur rarely and do not depend on the dose of the drug administered.

From the side of the blood and lymphatic system

Very Frequent: decrease in hematocrit and concentration of proteins in blood plasma due to hemodilution.

Frequent (depending on the dose administered): HES solutions in high doses can cause a decrease in the concentration of coagulation factors and, thus, affect blood coagulability. The bleeding time and the APTT index (Activated Partial Thromboplastin Time) may increase, and the FVIII / vWF activity (vWFE factor VIII) may decrease.

Anaphylactic reactions

Rare: when administering solutions of HES, anaphylactic reactions of varying severity occur. Therefore, all patients receiving HES solutions should be under constant supervision of medical personnel.If any anaphylactic reaction develops, the infusion should be stopped immediately and emergency therapy started.

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.

Influence on biochemical parameters

Introduction HES leads to an increase in the concentration of os-amylase in the plasma, which is associated with the formation of a complex of amylase with starch, which in turn is slowly excreted by the kidney and adrenal, which can be mistakenly regarded as a biochemical sign of pancreatitis.

Overdose:The main risk of acute overdose is associated with the possibility of hypervolemic overload. In this case, the administration of the drug Venofundin should immediately stop and prescribe, if necessary, diuretics.

Interaction:To avoid incompatibility, do not mix Venofundin with other drugs.

Special instructions:

Avoid bulk overload, which can occur due to an overdose of the drug. The dose of venofundin should be carefully selected in patients with concomitant cardiac disease.

Older patients also require constant monitoring and individual dose selection.

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.

Venofundin does not affect the definition of the blood group.

For the earliest possible detection of the threat of anaphylactic reactions, the first 10-20 ml of the preparation of venofundin should be administered slowly under the constant supervision of medical personnel.

Do not use if the solution is not transparent or contains visible mechanical inclusions if the bottle or container is damaged or pre-opened.

Form release / dosage:

Solution for infusion 6%

Packaging:

For 500 ml in bottles of low density polyethylene with euro-cap, which meet the requirements of the European Pharmacopoeia for parenteral preparations.

250 ml, 500 ml and 1000 ml in plastic containers made of Nexel Pharmaceutical M312 multilayer film meeting the requirements of the European Pharmacopoeia for parenteral preparations (Ecobag®). The container is placed in a secondary transparent plastic bag.

For 10 bottles of 500 ml, for 20 containers of 250 ml or 500 ml, for 10 containers of 1000 ml, along with instructions for use in the appropriate amount in a cardboard box (for hospitals).

Storage conditions:Store at temperatures between 2 ° C and 25 ° C. Do not freeze! Keep out of the reach of children.

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:LS-000657

Date of registration:24.05.2010 / 21.07.2016

Expiration Date:Unlimited

The owner of the registration certificate:B. Brown Mehlungen AGB. Brown Mehlungen AG Germany

Manufacturer: & nbsp

B. BRAUN MELSUNGEN, AG Germany

Representation: & nbspB. Brown Medikal, Open CompanyB. Brown Medikal, Open Company

Information update date: & nbsp26.01.2017

Illustrated instructions

Instructions

Venofundin (Venofundin)