Volyuven

Volyuven – the drug replacing plasma.

Form of release and structure

Dosage form – solution for infusions of 6%: colourless or weak-yellow color liquid with transparent or slightly opalescent structure (on 250 ml or 500 ml in the polyolefin "frifleks" containers, in a cardboard box of 15, 20 or 30 containers; on 500 ml in plastic bottles with a loop holder for a dropper, in a cardboard box of 10 or 20 containers).

Content of active agents is 1 l of solution:

• Pauly (Au - a 2-hydroxyethyl) starch (extent of molar substitution 0,4; the average molecular weight (Da) 130 000) – 60 g;
• Sodium chloride – 9 g;
• Na electrolyte + – 154 mmol/l;
• Cl-electrolyte – 154 mmol/l.

Theoretical osmolarity of solution – 308 ¼Äß¼/l, titrable acidity – is less than 1 mmol of NaOH/l, pH – 4,0-5,5.

Auxiliary components: sodium hydroxide, Acidum hydrochloricum, water for injections.

Indications to use

• Prevention and treatment of a hypovolemia of any etiology and the shock which arose owing to blood loss, an injury (including a backbone with injury of a spinal cord), a burn, multiorgan insufficiency, sepsis, acute adrenal insufficiency, in the period after surgery, an anaphylaxis and other states causing a collapse;
• Therapeutic hemodilution;
• Acute normovolemichesky hemodilution;
• Filling of the device of extracorporal blood circulation.

Contraindications

• Hypervolemia;
• Overhydratation;
• Congestive heart failure;
• Intracranial bleeding;
• Heavy disturbances of a blood coagulation;
• The condition of dehydration demanding correction of water and electrolytic balance;
• Use for the patients who are on a hemodialysis;
• The expressed renal failure with an anury or an oliguria;
• Hypernatremia;
• Hyperchloremia;
• Hypersensitivity to drug components.

With extra care it is necessary to use drug at the expressed liver failure.

As clinical data on a possibility of use of Volyuven during pregnancy and breastfeeding are absent, at pregnancy it is possible to appoint drug only in case the estimated advantage for mother surpasses possible threat for a fruit.

Route of administration and dosage

Solution is entered intravenously (in/in) way of long infusion.

The doctor appoints a daily dose and speed of infusion on the basis of clinical indications (blood loss degree, recovery or maintenance of a hemodynamics, hemodilution level (blood cultivation)).

Because of risk of emergence of anaphylactoid reactions, slow introduction of the first 10-20 ml of solution under careful control of a condition of the patient is recommended.

In emergency situations, for bystry completion of volume of the circulating blood and compensation of a hypovolemia, use solution in plastic containers on 500 ml under pressure (to avoid development of an air embolism before administration of solution air needs to be removed from a container).

At completion of volume of the circulating blood the daily dose of Volyuven should not exceed:

• Adults – from calculation for 50 ml on 1 kg of body weight of the patient;
• Patients from 10 to 18 years – on 33 ml on 1 kg of weight;
• Children of 2-10 years – on 25 ml on 1 kg of weight;
• Babies and children up to 2 years – on 25 ml on 1 kg of weight.

If necessary solution can be entered within several days repeatedly. Duration of therapy depends on weight and duration of a hypovolemia, hemodilution, hemodynamic efficiency of means.

Side effects

• Laboratory indicators: perhaps – increase in level of concentration of serumal amylase; at use of high doses – decrease in a hematocrit, proteins of plasma, coagulation factors, cultivation of components of blood; because of decrease of the activity of blood-coagulation factors of VIII (Villebrand) the bleeding time and other indicators of coagulability of blood which in 6 hours after the termination of infusion are recovered to initial level can increase;
• Dermatological reactions: against the background of long introduction of high doses – a skin itch;
• Others: allergic reactions.

Special instructions

During performing plasma substituting therapy of the patient it is necessary to limit in liquid reception. Patients with the expressed renal failures or heart failure are especially subject to risk of an overhydratation.

At heavy dehydration the patient should appoint saline solutions.

It is regularly necessary to control function of kidneys and level of liquid in an organism, to adhere to enough its receipt at patients with a heavy liver failure, disorder of fibrillation, including hard cases of an angiohemophilia.

Injections should be accompanied with control of electrolytes of blood serum.

High doses of Volyuven can exert impact on an agglutination test and at blood typing to yield false positive results. It should be considered at treatment of patients without the established blood group.

Increase in level of serumal amylase against the background of administration of hydroxyethylstarch (GEK) because of a delay of its removal through kidneys is possible.

Use of drug is shown to patients with a diabetes mellitus as it does not influence increase in content of glucose in blood serum after hydrolysis by alpha amylase.

When using in pediatrics the dose needs to be selected individually taking into account indicators of a hemodynamics, weight of a basic disease, a water balance, according to the need for colloids.

Volyuven's portability at use during performing surgeries (except cardiological) at children up to 2 years is comparable using 5% of albumine.

Medicinal interaction

It is recommended to avoid mixing of solution with other drugs. Mixing is allowed in exclusive situations, but in this case it is necessary to be convinced previously of compatibility of medicines (precipitation, opacification), it is good to mix solution and to follow rules of an asepsis.

Terms and storage conditions

To protect from children.

To store in the protected from light, dry place, at a temperature up to 25 °C, it is impossible to freeze.

Solution period of validity: in bottles – 5 years, in containers – 3 years.