Producer: Fresenius Kabi Gmbh (Frezenius Kabi) Germany
Code of automatic telephone exchange: B05AA
Pharm group: Plasma substituting and perfused solutions
Release form: Liquid dosage forms. Solution for infusions.
General characteristics. Structure:
Active ingredients: 60 g of hydroxyethylstarch 130/0.4 *, 4,63 g of sodium of acetate of trihydrate, 6,02 g of sodium of chloride, 300 mg of potassium of chloride, 300 mg of magnesium of chloride of hexahydrate, concentration of electrolytes: Na + 137 mmol/l, K+ of 4 mmol/l, Mg2 + 1.5 mmol/l, Cl-of 110 mmol/l, CH3COO-34 mmol/l, theoretical osmolarity 286.5 ¼Äß¼/l, titrable acidity <2.5 mmol of NaOH/l, pH 5.7-6.5.
* with extent of molar substitution 0.4 and with an average molecular weight of 130 kd
Excipients: Acidum hydrochloricum or sodium hydroxide - q.s. to pH 5.7-6.5, water for injections.
Pharmacodynamics. Plasma substituting drug. Волюлайт - an artificial colloid for completion of OTsK. Volyulayt's influence on OTsK and degree of hemodilution depend on characteristics of the hydroxyethylstarch (GEK) which is a part of drug: extents of molar substitution of hydroxyethyl groups (0.4), average molecular weight (130 000 Yes), nature of molar substitution of C2/C6 hydroxylic to groups (9:1), concentration of GEK (6%), and also doses and speeds of infusion.
Raw materials for the production of GEK 130/0.4 which is Volyulayt's part is starch of corn of wax ripeness.
The nature of substitution of C2/C6 influences volemichesky effect of drug. The indicator of substitution of C2/C6 at Volyulayt makes 9:1, i.e. hydroxylic groups located in more situation of stability of C2 in 9 times more than in situation C6. If in situation C2 there are ≥8 hydroxylic groups, then the volemichesky effect of GEK is stabler, than at other hydroxyethylstarches with this indicator less than 8.
GEK it is structurally related to a glycogen, than its high tolerance and low risk of anaphylactic reactions speaks. Волюлайт differs in high stability of solution and does not give flocculation at fluctuations of temperature.
The following electrolytes are a part of isotonic solution of drug of Volyulayt: sodium (Na+), potassium (To +), magnesium (Mg2+), chlorine (Sl-) and acetate an ion (SN3SOO-). The structure of cations is identical to physiological concentration of electrolytes in plasma. Acetate ion is oxidized in various bodies and has alkaline effect that allows to minimize risk of acidosis.
Ions of chlorine contain in the lowered quantity that interferes with development of a giperkhloremichesky metabolic acidosis. It is especially important at need of administration of drug for high doses and at the increased risk of a metabolic acidosis.
Волюлайт represents isooncotic plasma substituting solution, thanks to it, at its introduction the volume of intravascular liquid increases in proportion to the entered Volyulayt's volume.
The lasting volemichesky effect of Volyulayt makes 100% during 4 h from the moment of administration of drug in a vascular bed. The therapeutic effect proceeds to 6 h.
Pharmacokinetics. The pharmacokinetics of hydroxyethylstarches has difficult character and depends on the listed above molecular weight of GEK, extent of molar substitution and the nature of substitution of C2/C6 by hydroxylic groups.
Distribution. The average molecular weight of Volyulayt in in vivo blood plasma the first minutes after infusion makes 70 000-80 000 And remains above a threshold of renal filtering during the entire period of treatment.
At repeated introduction of 500 ml of solution of drug of GEK 130/0.4 6% within 10 days of essential accumulation of GEK in a blood plasma are not revealed.
Metabolism and removal. Later in/in introductions of GEK molecules weighing less than 60 000-70 000 Yes (a threshold of renal filtering) are quickly removed with urine, and larger molecules are split by blood plasma α-amylase, after that are also removed by kidneys. The extent of substitution of GEK is less, the quicker drug is hydrolyzed by α-amylase and removed from an organism, the accumulation in fabrics (in particular, in cells of immune system) and a blood plasma is less.
After introduction of 500 ml of Volyulayt the clearance makes 31.4 ml/min. of a blood plasma. After single introduction of 500 ml of drug of its T1/2 in the first phase of removal makes 1.4 h of a blood plasma, in the second phase - 12.1 h are also practically returned to reference values in 24 h.
Pharmacokinetics in special clinical cases. At patients with a stable renal failure (from weak to heavy) and KK <50 ml/min. of Cmax of GEK in blood was slightly above, than at patients with KK> 50 ml/min. at the same entered drug dose (500 ml). The renal failure did not influence T1/2 in a final phase of removal and at a size Cmax of GEK in a blood plasma. At KK> 30 ml/min. with urine 59% of the entered drug dose were removed, and at KK of 15-30 ml/min. - 51%.
Indications to use:
— treatment and prevention of a hypovolemia of any genesis and shock (owing to injuries, including a spine injury with injury of a spinal cord, blood loss, a burn, sepsis, multiorgan insufficiency, to the postoperative period, acute adrenal insufficiency, an anaphylaxis and other states which are followed by development of a collapse);
— acute normovolemichesky hemodilution;
— therapeutic hemodilution;
— filling of the device of extracorporal blood circulation.
Route of administration and doses:
Drug is intended for in/in infusion. Because of possible anaphylactic reactions the first 10-20 ml of Volyulayt need to be entered slowly and at careful observation of a condition of the patient. The daily dose and speed of infusion depend on blood loss, maintenance or recovery of a hemodynamics and on cultivation of blood (hemodilution).
For adults the maximum daily dose makes 50 ml/kg of mass of bodies/days that is equivalent to 3 g of GEK, 6.85 mmol of sodium and 0.2 mmol of potassium on body weight kg. The specified dose corresponds to 3500 ml of solution of Volyulayt for the patient with the body weight of 70 kg.
At Volyulayt's use for children, the dose should be selected individually, according to the hemodynamic status and associated diseases.
For completion of OTsK the maximum daily dose at children aged from 10 up to 18 years makes 33 ml/kg, aged from 2 up to 10 years - 25 ml/kg, aged up to 2 years and newborn - 25 ml/kg.
Волюлайт it is possible to enter repeatedly within several days, depending on needs of the patient. Duration of treatment depends on duration and weight of a hypovolemia, hemodynamic efficiency of therapy and on hemodilution.
Features of use:
Use at pregnancy and feeding by a breast. There are no clinical data on Volyulayt's use for pregnant women and nursing mothers. Volyulayt's use at pregnancy is possible only when the potential advantage of therapy for mother exceeds possible risk for a fruit.
Now there are no data on allocation of GEK and electrolytes with breast milk therefore, at Volyulayt's appointment it is necessary to provide a possibility of the termination of breastfeeding.
Use at abnormal liver functions. With care it is necessary to use drug at patients with a serious illness of a liver.
Use at renal failures. Use at a renal failure of heavy degree with an oliguria or an anury is contraindicated; to the patients who are on a hemodialysis.
Use for children. With care it is necessary to use drug at children under 2 years.
Special instructions. It is necessary to avoid an overload liquid. The risk of an overhydratation should be considered first of all at patients with heart failure and a heavy renal failure. In such cases Volyulayt's dose should be reduced. At heavy dehydration treatment is begun with administration of crystalloid solution for infusions.
At direct comparison of GEK of 130/0.4 6% in the balanced electrolytic solution (Волюлайт) and GEK of 130/0.4 6% in normal saline solution (Volyuven) similar efficiency and the general profile of safety were established.
At a metabolic alkalosis and also when it is necessary to avoid an alkalosis, use not of solution of Volyulayt, and the similar drug supporting GEK 130/0.4 (6%) in 0.9% chloride sodium solution is preferable (Volyuven). If it is necessary to avoid giperkhloremichesky acidosis, then Volyulayt's use (GEK 130/0.4 (6%) in the balanced solution of electrolytes) has advantages before other solutions.
At Volyulayt's appointment it is necessary to provide sufficient intake of liquid and to regularly monitorirovat function of kidneys and balance of liquid. It is necessary to control serumal concentration of electrolytes carefully.
Drug is intended only for single use. Before use it is necessary to remove an external protective bag. To use solution immediately after packaging opening. To use only transparent solution which is not containing mechanical inclusions from the unimpaired packaging. Unused solution should be destroyed.
Influence on ability to driving of motor transport and to control of mechanisms. Волюлайт does not exert impact on ability to drive the car and to use the equipment.
Determination of frequency of side reactions: very often (≥ 1/10), it is frequent (≥ 1/100-<1/10), infrequently (≥1/1000-<1/100), is rare (≥ 1/10 000-<1/1000).
From coagulant system of blood: seldom (in high doses) - blood coagulation disturbances which depend on a dose.
Allergic reactions: seldom - anaphylactic reactions (hypersensitivity, easy grippopodobny symptoms, bradycardia, tachycardia, a bronchospasm, not cardiogenic fluid lungs). In this case it is necessary to stop immediately administration of drug and to take necessary urgent measures.
Dermatological reactions: often (dozozavisimy reactions) at prolonged use in high doses - the itch which can develop several weeks later after introduction of the last dose of drug and sometimes remains several months.
From laboratory indicators: often (dozozavisimy reactions) - increase in content of serumal amylase (that complicates diagnosis of pancreatitis). Increase in activity of amylase is connected with formation of a complex amylase GEK which is slowly removed. Increase in activity of amylase does not demonstrate existence of pancreatitis. At introduction in high doses cultivation of blood can lead to cultivation of its components, such as factors of coagulation and other proteins of plasma, and decrease in gematokritny number.
Interaction with other medicines:
There are no data on interaction with other drugs therefore solution of Volyulayt should not be mixed with other medicines.
Introduction of GEK can lead to increase in activity of serumal amylase. This effect should be considered not as disturbance from function of a pancreas and as result of formation of a complex of GEK with amylase with the subsequent delay of its removal by kidneys. Now cases of such interaction are unknown.
Drug does not influence increase in concentration of glucose in blood serum after hydrolysis by α-amylase and can be applied at patients with a diabetes mellitus.
Care at co-administration of drugs which can cause a delay of potassium or sodium is necessary.
— heavy disturbances of coagulant system of blood;
— intracranial bleeding;
— the condition of dehydration demanding correction of water and electrolytic balance;
— a renal failure of heavy degree with an oliguria or an anury;
— the patients who are on a hemodialysis;
— hypersensitivity to drug components (including to starch).
With care it is necessary to use drug at patients with heavy electrolytic disturbances, such as a hyperpotassemia, a hypernatremia, a gipermagniyemiya and a hyperchloremia; at patients with a serious illness of a liver and a serious hemorrhagic illness, for example, an angiohemophilia; at children under 2 years.
Symptoms: are possible an overload of cardiovascular system (for example, edematization of lungs).
Treatment: to immediately stop administration of drug and if necessary to appoint "loopback" diuretics.
Drug should be stored in the place, unavailable to children, at a temperature not above 25 °C; not to freeze. A period of validity - 3 years.
According to the recipe
250 ml - the plastic packagings of the frifleks type (20) supplied with two polypropylene connecting ports - boxes cardboard.
250 ml - the plastic packagings of the frifleks type (30) supplied with two polypropylene connecting ports - boxes cardboard.
250 ml - the plastic packagings of the frifleks type (35) supplied with two polypropylene connecting ports - boxes cardboard.
250 ml - the plastic packagings of the frifleks type (40) supplied with two polypropylene connecting ports - boxes cardboard.
500 ml - the plastic packagings of the frifleks type (15) supplied with two polypropylene connecting ports - boxes cardboard.
500 ml - the plastic packagings of the frifleks type (20) supplied with two polypropylene connecting ports - boxes cardboard.