Hayes-Steril of 10%

General characteristics. Structure:

Active ingredient: 100 g of hydroxyethylstarch 200/0,5.

Including: Na + 154 mmol/l, Cl-of 154 mmol/l, рН 3.5-6.0, titrable acidity less than 1 mmol of NaOH/l, theoretical osmolarity 308 ¼Äß¼/l.

Excipients: sodium chloride, water for injections, sodium hydroxide - q.s. for correction pH.

Pharmacological properties:

Pharmacodynamics. Plasma substituting drug. Gidroksietilkrakhmal (GEK) receive from amylopectin and characterize on the molecular weight and extent of substitution. For Hayes-steril the average molecular weight of GEK makes 200 000 Yes, and extent of substitution - about 0.5 that means that 5 hydroxyethyl groups are the share of 10 glucosic remains of amylopectin. GEK it is structurally related to a glycogen that explains its high tolerance and low risk of anaphylactic reactions. Hayes-steril differs in high stability of solution and does not give flocculation at fluctuations of temperature.

Drug infusion Hayes-steril (500 ml in 15 min.) the examinee with a hypovolemia leads to increase in volume of plasma approximately by 100% of the entered volume (at Hayes-steril's infusions 6%) or for 145% (in case of Hayes-steril's infusions 10%) within 3-4 hours, Hayes-steril provides improvement of a hemodynamics and microcirculation for 3-4 hours.

Pharmacokinetics. Metabolism and removal. GEK is exposed to zymolysis blood alpha amylase that leads to education oligo-and polysaccharides of various molecular weight.

GEK has T1/2 from a blood channel about 4 hours. It is removed generally through kidneys; 50% of the entered dose are removed with urine less, than in 24 hours. A small amount of drug is temporarily deposited in fabrics, and only 10% continue to circulate in blood serum. Sodium chloride is removed preferential through kidneys, and a small amount is removed with then through skin.

Indications to use:

— treatment and prevention of a hypovolemia and shock at surgical interventions (hemorrhagic shock), traumatic defeats (traumatic shock), infections (septic shock), burns (burn shock);

— acute normovolemichesky hemodilution for reduction of administration of donor blood at surgical interventions;

— therapeutic hemodilution.

Route of administration and doses:

Hayes-steril of 6%, 10% is applied intravenously at adults and children is more senior than 3 years.

The doses applied to treatment and prevention of a hypovolemia and shock. Maximum daily dose:

6% solution: 33 ml/kg/days (=2500 ml on 75 kg of body weight a day or = 2 g of GEK/kg/days).

10% solution: 20 ml/kg/days (=1500 ml on 75 kg of body weight a day or = 2 g of GEK/kg/days).

Maximum speed of infusion:

6% solution: 20 ml/kg/h (= 1500 ml on 75 kg of body weight an hour or =1,2 g of GEK/kg/h).

10% solution: 20 ml/kg/h (= 1500 ml on 75 kg of body weight an hour or 2 g of GEK/kg/h).

At children aged up to 10 years the speed of infusion should not exceed 15 ml/kg/h.

Children are more senior than 12 years: an average daily dose - 33 ml/kg, the maximum daily dose - 33 ml/kg (2 g of hydroxyethylstarch on kg/days); to children from 3 to 12 years, respectively - 15-20 ml/kg and 33 ml/kg.

The doses applied to decrease in amount of donor blood at surgeries (acute normovolemichesky hemodilution).

For direct preoperative substitution of own blood simultaneous introduction of Hayes-steril of 6% in the ratio 1:1 is recommended (to a hematocrit indicator not lower than 30%).

Blood selection: 2-3 multiple on 500 ml of own blood.

Day dose: 2-3 injections on 500 ml of Hayes-steril of 6%.

Speed of capture of blood of 1000 ml in 15-30 min. Rate of administering of Hayes-steril of 6%-1000 ml in 15-30 min. The recommended doses for gemodilyutsionny therapy.

As criterion serves the decrease in an indicator of a hematocrit defined for each patient. Hayes-steril's infusion 6%, 10% can be performed izovolemichesk (with simultaneous selection of own blood) or hypervolemically (without selection of own blood) in small (250 ml), averages (500 ml) or high doses (500 ml twice). It is necessary to avoid a hypervolemia at too bystry administration and too high doses of drug, the limit dose makes 1.2 g GEK/kg/day.

Use the following daily doses and rate of administering:

Daily dose:

- 250 ml (low dose)

- 500 ml (average dose)

- 2 times on 500 ml a day (a high dose)

Infusion speed:

- 250 ml in 0.5 - 2 hours

- 500 ml in 4-6 hours

- 2 times on 500 ml in 8-24 hours.

Use duration. Treatment and prevention of a hypovolemia and shock: degree and duration of a hypovolemia define a daily dose and duration of use of Hayes-steril.

Decrease in use of donor blood at surgical interventions (acute normovolemichesky hemodilution).

Acute normovolemichesky hemodilution is applied once at surgical interventions. Repeated use of Hayes-steril is possible at normal values of a hematocrit (not lower than 30%).

Therapeutic hemodilution. Hayes-steril's use for gemodilyutsiony therapy is recommended within 10 days.

Features of use:

Use at pregnancy and feeding by a breast. There are no data on Hayes-steril's use for pregnant women and nursing mothers.

Use of drug during pregnancy and in the period of a lactation perhaps only according to vital indications.
 
Use at abnormal liver functions. With care: chronic diseases of a liver

Use at renal failures. It is contraindicated at an acute renal failure (an oligonuriya, an anury). With care: chronic renal failure.
 
Use for children. It is contraindicated to children up to 3 years.

Special instructions. In an initiation of treatment it is necessary to carry out control of concentration of creatinine in serum.

At boundary indicators of content of creatinine (106-177 µmol/l - the compensated renal failure) daily control of intracellular and extracellular balance of liquid and secretory function of kidneys is necessary.

In need of mixing with other medicines the full asepsis has to be observed. It is necessary to be convinced of compatibility of medicines and their good mixing.

Because of possible anaphylactic reactions the first 10-20 ml of Hayes-steril have to join slowly and at careful observation of a condition of the patient.

At use of drug regular control of water and electrolytic balance and quantity of leukocytes and thrombocytes is necessary.

Side effects:

Seldom - allergic reactions of various degrees of severity: skin rash, tachycardia, sharp decrease in the ABP, dizziness, nausea, vomiting, a bronchospasm, an acute anaphylaxis up to an apnoea and cordial activity. At emergence of allergic reactions administration of solution has to be immediately stopped, and holding the emergency actions depending on clinical symptoms and severity is at once begun. It is necessary to appoint antihistaminic and other drugs, glucocorticosteroids (Prednisolonum of 120 mg intravenously), Epinephrinum of 0.05-0.1 mg intravenously, administration of albumine of 5%.
 
Prolonged daily use of Hayes-steril in average and high doses often causes the itch which is difficult giving in to treatment. In these cases decrease in the maximum daily dose to 250 ml a day is recommended.
 
Occasionally - pains in lumbar area. In this case injection of drug should be stopped, to provide plentiful administration of liquid and frequent control of creatinine of serum. High doses of Hayes-steril as a result of effect of cultivation can cause increase in a bleeding time, however Hayes-steril's injection does not cause clinically significant bleedings. It is necessary to pay attention to possible decrease in a hematocrit and development of a hypoproteinemia. At Hayes-steril's use activity of serumal amylase can increase that can disturb in diagnosis of pancreatitis.

Interaction with other medicines:

Simultaneous use of hydroxyethylstarch with heparin or peroral to anti-coagulants can also increase a bleeding time.

Special attention needs to be paid to the patients accepting other medicines, especially at reception of beta-blockers and vasodilators as changes of the system ABP and ChSS can be not found despite objemozameshchayushchy therapy.

It must be kept in mind that GEK can exert impact on kliniko-chemical indicators (glucose, protein, SOE, fatty acid, cholesterol, a sorbitdegidrogenaza, specific weight of urine).

Any data on interaction of hydroxyethylstarch with foodstuff are absent.

Contraindications:

— intracranial hypertensia;
— arterial hypertension;
— intracranial bleeding;
— dekompensirovanny chronic heart failure;
— acute renal failure (oligonuriya, anury);
— heavy hemorrhagic diathesis;
— cardiogenic fluid lungs;
— hypocoagulation;
— coagulopathy;
— overhydratation;
— hypervolemia;
— dehydration (in need of correction of electrolytic exchange);
— hypofibrinogenemia;
— the expressed thrombocytopenia;
— hypernatremia;
— hemodialysis;
— children's age up to 3 years;
— hypersensitivity (including to starch).
 
With care: the lactation period, the compensated chronic heart failure, a chronic renal failure, chronic diseases of a liver, an angiohemophilia, hemorrhagic diathesis.

Overdose:

Drug overdose cases are not registered now.

Storage conditions:

Drug should be stored at a temperature not above 25 °C, in the place protected from light. Freezing is not allowed. To store in the place, unavailable to children. A period of validity - 5 years in glass or plastic bottles; 3 years - in the containers "frifleks".

Issue conditions:

According to the recipe

Packaging:

250 ml - bottles glass (10) - boxes cardboard.
250 ml - bottles glass with holders for a dropper (10) - a box cardboard.
250 ml - bottles plastic with a loop holder for a dropper (10) - a box cardboard.
250 ml - bottles plastic with a loop holder for a dropper (20) - a box cardboard.
250 ml - containers the polyolefin "фрифлекс" (1) - packages plastic (10) - boxes cardboard.
250 ml - containers the polyolefin "фрифлекс" (1) - packages plastic (15) - boxes cardboard.
250 ml - containers the polyolefin "фрифлекс" (1) - packages plastic (20) - boxes cardboard.
250 ml - containers the polyolefin "фрифлекс" (1) - packages plastic (30) - boxes cardboard.
500 ml - bottles glass (10) - boxes cardboard.
500 ml - bottles glass with holders for a dropper (10) - a box cardboard.
500 ml - bottles plastic with a loop holder for a dropper (10) - a box cardboard.
500 ml - bottles plastic with a loop holder for a dropper (20) - a box cardboard.
500 ml - containers the polyolefin "фрифлекс" (1) - packages plastic (10) - boxes cardboard.
500 ml - containers the polyolefin "фрифлекс" (1) - packages plastic (15) - boxes cardboard.
500 ml - containers the polyolefin "фрифлекс" (1) - packages plastic (20) - boxes cardboard.
500 ml - containers the polyolefin "фрифлекс" (1) - packages plastic (30) - boxes cardboard.